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Outcome of Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty for Early Medial Compartment Arthritis: A Randomized Study
Accepted Manuscript Outcome of Unicondylar Knee Replacement Versus Total Knee Replacement for Early Medial Compartment Arthritis: A Randomized Study Vikas Kulshrestha, MS (Orth), Barun Datta, MS (Orth), Santhosh Kumar, DNB (Orth), Gaurav Mittal, MS (Orth) PII:
S0883-5403(16)30899-3
DOI:
10.1016/j.arth.2016.12.014
Reference:
YARTH 55545
To appear in:
The Journal of Arthroplasty
Received Date: 17 August 2016 Revised Date:
1 December 2016
Accepted Date: 12 December 2016
Please cite this article as: Kulshrestha V, Datta B, Kumar S, Mittal G, Outcome of Unicondylar Knee Replacement Versus Total Knee Replacement for Early Medial Compartment Arthritis: A Randomized Study, The Journal of Arthroplasty (2017), doi: 10.1016/j.arth.2016.12.014. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Title: Outcome of Unicondylar Knee Replacement Versus Total Knee Replacement for Early Medial Compartment Arthritis: A Randomized Study
Author :
1.
Vikas Kulshrestha, MS (Orth)*
2.
Barun Datta, MS (Orth) ^
3.
Santhosh Kumar, DNB (Orth)
4.
Gaurav Mittal, MS (Orth)
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Short Title: “Outcomes Bilateral TKR Vs UKR; A Randomized study”
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#
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* Senior Advisor Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India. Email : [email protected]. +918826292986
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^ Senior Advisor Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India. Email : [email protected] +919818212669 + Classified Specialist Orthopaedics, Department Of Orthopaedics, Air Force Hospital, Jorhat, India. Email : [email protected] +919986663511 #
Graded Specialist Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India. Email: [email protected] +919717393460
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No financial support received from any outside agency.
Research carried out at Army Hospital Research & Referral, New Delhi with institutional resources.
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No conflict of interests
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Corresponding Author :
Dr Vikas Kulshrestha Joint Replacement Centre
Army Hospital Research & Referral Delhi Cantt New Delhi – 110010 Email Id: [email protected] Mobile: +918826292986
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Title: Outcome of Unicondylar Knee Replacement Versus Total Knee Replacement for Early
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Abstract:
Medial Compartment Arthritis: A Randomized Study
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Background: With increasing number of patients with early osteoarthritis of knee opting for
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Key Words: unicondylar knee replacement, total knee replacement, patient reported outcome,
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to them would improve outcomes. Methods: Primary objective of our study was to look for any difference in patient reported outcome and function at two year follow up in patients undergoing UKR as compared to TKR. Our study was a randomized study with parallel assignment conducted at a high volume specialized Arthroplasty Centre. Eighty patients with
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bilateral isolated medial compartment knee arthritis were randomized into simultaneous twoteam bilateral TKR (n=40) and UKR (n=40) group. We finally analyzed 36 patients in each group. Main outcome measure was improvement in Knee Outcome Survey – Activity Of Daily
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Living Scale (KOS – ADLS) and High Activity Arthroplasty Score (HAAS) obtained at two-year follow up. Results: Improvement in KOS-ADLS and HAAS at two year was similar (p = 0.2143 & 0.2010) in both groups. Performance as assessed with Delaware index was also similar. Length of hospital stay was less in UKR group (6.6 days as against 5.4 days). Complications and readmission rates were more in TKR group (Nil in UKR group; 08 in TKR group). Conclusion: At two year follow up, UKR provides similar improvement in patient reported outcomes, function and performance as compared to TKR when performed in
complications.
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patients with early arthritis. However, UKR patients have shorter hospital stay and fewer
high activity, performance
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surgical outcomes. It is being presumed that offering Unicondylar Knee Replacement (UKR)
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Total Knee Replacement (TKR) surgery, there has been increase in patients dissatisfied with
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patients with arthritic knees are opting for total knee replacement (TKR) [1]. An improved surgical technique, safe anesthetic procedures, effective pain control, and accelerated rehabilitation coupled with a modern implant design have ensured predictable outcomes in TKR [2]. Therefore, arthroplasty surgeons are suggesting TKR to patients with early arthritis.
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To avoid pain and maintain the quality of life, even patients are opting for this surgery at an early stage of the disease [3]. However, 15%–20% patients are unsatisfied with their surgical outcome [3,4]. Unicondylar knee replacement (UKR) has excellent functional outcomes with high patient satisfaction, but concern persists regarding its durability and need for revision surgery [5-10]. Because of a limited surgical volume, complex surgical technique, and steep
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learning curve, only a few arthroplasty surgeons are offering this option to their patients [9,11]. More than 30% of patients considered for TKR are candidates for UKR, but only 5% of all knee replacements performed are Unicondylar.
Currently, both procedures remain the
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standard of care for disabling early medial compartmental osteoarthritis. Few studies have shown the superiority of UKR over TKR in terms of early outcomes and functional restoration, whereas others have highlighted their midterm revisions because of technical failures [12,13]. Most of these studies are retrospective cohort studies, which are observational in nature. This study was conducted at a high-volume joint replacement center. Since 2012, two senior fellowship-trained arthroplasty surgeons who perform more than 1000 procedures/year (10% UKR) began offering UKR to patients with disabling early arthritis. This randomized
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Because of its proven success and growing popularity, an increasing number of
study compared the functional outcomes, activity levels, and performance of simultaneous bilateral UKR and TKR in patients with bilateral early medial compartment osteoarthritis. Material and Methods
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Introduction
The study was a single-center, superiority-type randomized trial, in which patients from February 2013 to May 2014 were enrolled after obtaining ethical approval.
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Eligibility: All patients with medial compartment bilateral arthritis who opted for surgery were enrolled in the study after appropriate counseling (Fig. 1, 2). The trial had an equipoise approach because a single operating team consisting of two fellowship-trained arthroplasty surgeons with adequate experience in both fixed-bearing limited-incision UKR and conventional TKR performed all procedures. Surgeons selected suitable patients who could be offered either simultaneous bilateral UKR or TKR and accordingly informed them. Only patients who understood the trial procedure and consented to random selection were recruited after anesthetic clearance. At this stage, the study coordinator in the outpatient department used a computer-generated sequence in a sealed envelope to implement randomization. The patient was informed whether the procedure was a planned UKR or TKR. All
patients
underwent
preoperative
education,
optimization
of
comorbidities,
and
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rehabilitation training. At any time in the trial, patients had the option of choosing the type of
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Inclusion criteria: (a) Medial compartment osteoarthritis with a complete loss of joint space
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Exclusion criteria: (a) Fixed varus deformity in any knee. (b) A more than 10-degree, fixed
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Sample size calculation: According to our literature review, the minimum clinically relevant
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Surgical procedure: As an institutional protocol, all patients who planned to undergo joint
surgery (TKR or UKR). Patients also understood and permitted the operating surgeon to make a final decision regarding UKR or TKR depending on the perioperative findings.
observed on anteroposterior or lateral radiographs of both knees. (b) No clinical or functional anterior cruciate ligament (ACL) laxity in any knee. (c) Radiographically normal lateral
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compartment joint space in both knees. (d) A less than 15-degree, correctable varus deformity in both knees.
flexion deformity in any knee. (c) Currently suffering from or a history of inflammatory/infective
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joint disease. (d) The presence of other lower limb bone or joint pathologies. (e) Patellofemoral arthritis with the involvement of the lateral facet of any knee. (f) A history of
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previous knee surgery. (g) An inability to participate in follow-up.
difference in knee outcome survey–activity of daily living scale (KOS–ADLS) scores is 7.14 points [14-16]. This was considered our primary outcome and was used to calculate the sample size. Because this was a superiority trial, we hypothesized that at 2 years postoperatively, the difference in the mean improvement in KOS–ADLS scores in the simultaneous UKR group compared with in the TKR group would be more than 7.14 points
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[15]. Using Stata Version 12 (StataCorp LP, Texas, USA), we calculated that at a one-sided alpha error of 0.05 and 90% power, 31 patients would be required in each group to obtain significant differences. Taking into account that 10%–15% patients may be lost to follow-up, we planned to enroll 35 patients in each group. We also expected that some patients,
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depending on their perioperative findings, may receive TKR on one side and UKR on the other and would be dropped out from analysis; presuming that this occurs in 10% patients, we
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increased the sample size to 40 in each group.
replacement surgery were advised daily chlorhexidine wash, which was to be initiated at 3 days prior to surgery. Patients were admitted on the evening prior to surgery for undergoing partial preparation, with the overnight use of chlorhexidine wipes. On the evening before surgery, the study nurse, surgeon, and anesthesia resident reconfirmed patient optimization. All diabetic patients were reviewed by an endocrinologist to ensure good perioperative blood glucose
control.
A
color-coded
flag
system
was
used
to
label
patients
with
cardiac/pulmonary/renal/delirium risks. Appropriate risk instructions were carried out in the perioperative period. As pre-emptive pain control, on the morning of surgery a buprenorphine skin patch was applied, and oral drugs, including acetaminophen, a cox-2 selective inhibitor, and gabapentin, were administered. Risk screening for deep vein thrombosis (DVT) was
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ACCEPTED MANUSCRIPT performed on the evening before surgery to plan the combination of chemoprophylaxis (oral aspirin or inj low molecular weight heparin) and mechanical prophylaxis [17]. All surgeries were performed under single-shot spinal anesthesia. At induction, all patients received weight- and comorbidity-adjusted doses of cefazolin or cefuroxime and an aminoglycoside. In all patients one more dose of antibiotic was repeated at 8 h after surgery. All patients received tranexamic acid (1 gm inj.) at induction and one repeated dose at 3 h after surgery. To
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minimize postoperative nausea and vomiting and to improve pain control, dexamethasone (8 mg inj.) was administered at induction and repeated after 24 h [18]. All surgeries in the TKR group were performed through a midline skin incision, followed by a medial parapatellar arthrotomy. All UKR surgeries were performed through a limited medial parapatellar incision, without entering the rectus tendon. All surgeries were simultaneously performed on the right
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and left sides by two surgical teams, but a tourniquet was used only on one side. In patients who planned to undergo UKR, after exposure, the surgeons examined the integrity of the ACL, assessed for any arthritic changes in the lateral knee compartment and lateral
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patellofemoral joint. In case of any evidence of arthritis in these compartments or loss of ACL, the surgery was converted to TKR on one or both sides, depending on the findings. Medial patellofemoral arthritis was ignored while performing UKR. All TKRs were performed using a cemented posterior stabilized implant without patellar resurfacing, and UKRs were performed using a fixed-bearing design. Mechanical alignment principles were applied in TKR by using an intramedullary guide for the femur and an extramedullary guide for the tibial cut. In UKR, an extramedullary guide was used for the tibial cut, and the tibial block technique was used
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for the distal femur cut, without opening the femoral canal. No patellar resurfacing was performed. The arthrotomy was closed using a barbed suture, without the placement of a drain, and all wounds were dressed using silver impregnated hydrocolloid dressing. Postoperatively, the limb was elevated with the knee placed in a flexed position for 24 h. All patients were made to perform regular ankle pumps as soon as the effect of regional
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anesthesia wore off. A pneumatic sequential compression device or electrical stimulation of the calf was used for mechanical prophylaxis. Oral aspirin or low molecular weight heparin was used for chemoprophylaxis, as per the risk score. Patients were ambulated on the first
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postoperative day and were put on an accelerated rehabilitation protocol. Blood transfusion was avoided by not following any transfusion trigger. Effective pain control was achieved through the initiation of pre-emptive multimodal pain medications, which were continued postoperatively. Narcotics and injectable nonsteroidal anti-inflammatory drugs were sparingly used as rescue analgesia. Being a state-sponsored hospital we had an attached rehabilitation center; hence, most patients were discharged at 3–7 days postoperatively after the completion of early rehabilitation goals. Plain anteroposterior and lateral radiographs as well as standing full-length hip, knee, and ankle radiographs were taken to confirm appropriate implant alignment and fixation (Fig. 1, 2). Patients and their caregivers were trained regarding the home rehabilitation program, which focused on pain control, range of movement,
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quadriceps strengthening. and functional mobility. Patients were followed up at 2 and 6 weeks
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Enrolment and Follow-up: Eighty patients with isolated bilateral medial compartment knee
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Statistical Analysis: Statistical analysis was performed using Stata Version 12 (StataCorp LP,
postoperatively for wound care and early rehabilitation.
arthritis were recruited between February 2013 and April 2014; 40 patients each were parallelly assigned into the simultaneous bilateral UKR and TKR groups. After randomization, two patients from the UKR group opted for TKR; however, their results were analyzed in the
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UKR group, in accordance with the intention-to-treat (ITT) principle. Four patients in the UKR group in whom one knee underwent UKR and the other TKR were dropped and not included in analysis. At 2 years postoperatively, the follow-up rate was more than 90%, but four patients in the TKR group could not attend follow-up visits because they relocated. Through telephonic interviews, they reported their level of satisfaction and occurrence of any
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complications; however, KOS–ADLS scoring could not be completed, and the final range of motion could not be recorded so they were dropped from analysis (Fig. 3). Because of random selection, both the TKR and UKR groups were similar in demographics and
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comorbidities (Table 1). The mean age in the UKR group was 59.7 years, which was similar to that in the TKR group (i.e., 62.2 years). The number of females was higher in both groups (UKR: n = 30, 83%; TKR: n = 26, 72%). Most patients were overweight and had an average 2
body mass index of 28 (18–38) kg/m . More than 60% patients in both groups had one or more comorbidities. Except for one, all patients were accepted as ASA I/II in the preanesthetic checkup. The mean preoperative hemoglobin level was more than 12 gm% in both
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groups. The primary outcome measures for the study were KOS-ADLS, high activity arthroplasty score (HAAS), and patient satisfaction. KOS–ADLS is a patient-reported outcome measure specifically designed to assess outcomes after TKR surgery; it is a validated measure of change over time [16]. HAAS is a highly consistent, reproducible, and validated scoring system with the specific advantage of its ability to discriminate the activity level of
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younger patients undergoing TKR without any ceiling effect [19]. In addition, we objectively assessed their performance using the Delaware index [20]. We also recorded the Oxford knee and European Quality of Life index (EQ5D) scores [21]. A trained physiotherapist
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performed the baseline scoring and follow-up assessment. Regarding secondary outcomes, we compared complications, length of hospital stay, readmissions/revision surgery, and final range of movements at 2 years of follow-up (Fig. 3).
Texas, USA). Outcome assessment was performed according to the ITT principle [22]. Patients who received TKR on one side and UKR on the other were excluded from analysis. Patient demographics, including the functional co-morbidity index scores, were compared between the study groups to identify any differences that might confound the outcome comparisons. Mean, standard deviation, and range were presented for continuous parameters. A two-sample independent t-test or nonparametric Mann-Whitney–Wilcoxon test was used to compare continuous variables between the two groups, according to the
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distribution of the variables. The gain in KOS-ADLS, HAAS, and satisfaction at 2 years of
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Results
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KOS–ADLS, HAAS, and Patient satisfaction.
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(Table 2). KOS–ADLS scores in the UKR and TKR groups were 40.4 and 42.9, respectively (p = 0.172). In addition, the HAAS (UKR, 9.1; TKR, 8.9) and preoperative patient satisfaction (UKR, 37.4; TKR, 40.4) scores were similar between the two groups. At the 2-year follow-up, performance was objectively assessed using the Delaware index and was found to be
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comparable between the two groups. The UKR and TKR groups had similar KOS–ADLS scores (90.4 and 89.9, respectively) (; Table 3). At 2 years postoperatively, the mean
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improvement in KOS–ADLS scores in the UKR group was 50 (range, 33–70), which was closely matched by that in TKR group (47; range, 17–74); a mean difference of 3.0 points was documented (p = 0.2143), but this difference was clinically not significant. The gain in HAAS score was very similar between the two groups (UKR, 3.1; TKR, 2.8; p = 0.2010). Preoperatively, patient satisfaction in the UKR group was 37%, which improved to 89% at 2 years; in the TKR group, it improved from 40% to 86%. In addition, the gain in performance (as assessed by Delaware score; Table 3) and the improvement in Oxford and EQ5D scores were similar between the two groups. Surgical details
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Preoperative baseline function and performance were similar between the two groups
The average operative time for the two teams to perform simultaneous bilateral UKR was 65 min (range, 43–105 min), which was similar to that for TKR (56 min; range, 30–83 min). In the UKR group, tibial spine avulsion (n = 1) and a chip fracture of the medial tibia
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Mann-Whitney–Wilcoxon test to identify significant differences between the two groups.
plateau (n = 1), which was fixed using K wires and lag screws, were observed. However, the postoperative protocol was unaltered as fixation was stable. According to DVT risk
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follow-up compared with the values at baseline was subjected to statistical analysis using
assessment, 5 and 11 patients in the UKR and TKR groups received injections of low molecular weight heparin as chemoprophylaxis. The remaining patients received aspirin and mechanical prophylaxis. The length of hospital stay, including early rehabilitation, was significantly less in the UKR group (5.4 days) than that (6.6 days) in the TKR group (p = 0.0212).
Complications and Reoperation In the UKR group, no postoperative complications or readmissions were observed (Table 4). In the postoperative period in the TKR group, one patient experienced respiratory failure secondary to narcotic overdose and was successfully managed with noninvasive ventilation, two underwent blood transfusion for severe anemia, one had peri-prosthetic
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fracture and was readmitted for fixation, one complained of stiff knees at 6 weeks and was
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Discussion
successfully managed with dressing.
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Over the last two decades, TKR has been established as the most successful surgical procedure [1]. Because of its growing popularity and satisfying outcomes, an increasing number of patients with knee osteoarthritis are opting for TKR. Although the surgery is offered to patients with moderate-to-advanced knee arthritis, the threshold for surgery depends on patients’ symptoms and disability [23]. UKR is an established procedure
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for early knee arthritis. Until recently, its use was limited because of questionable longevity [24-26]. Because of a modern implant design, improved surgical technique, and better case selection, a renewed interest in UKR has been observed [27]. Numerous retrospective data
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analyses have reported improved functional outcomes and decreased morbidity and mortality but increased revision rates at midterm follow-up after UKR compared with after TKR [24-26]. Accordingly, surgeons have begun offering UKR to patients with early isolated medial compartment arthritis to improve patient satisfaction after knee replacement. However, the evidence in favor of UKR remains weak because most of the studies are retrospective database reviews [8, 28-40]. Furthermore, most studies have compared absolute outcome scores and not the variation from baseline scores. Many studies also did not match the
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baseline disease severity of the patients undergoing UKR with those undergoing TKR. Most studies have compared unilateral procedures and not considered the extent of disease/disability of the other knee, which would hamper outcome comparisons. Only one randomized study, which was performed 20 years previously [8], has compared the patient reported outcomes of unilateral UKR and TKR, and none have compared the outcomes of the
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and were managed conservatively, and two had delayed wound healing and were
simultaneous bilateral procedure.
This is the first study to assess the subjective outcomes, activity levels, and performance of simultaneous bilateral UKR or TKR in randomly allocated patients. Because it
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readmitted for manipulation, two complained of anterior knee pain with occasional crepitus
is a minimally invasive procedure, UKR provides early recovery of function compared with TKR [41,42]. However, the optimal recovery of function in patients undergoing TKR required 1–2 years [43], according to a comparison of outcomes between the groups. Contrary to findings of multiple database analysis and observational cohort studies [8,28-40], TKR and UKR demonstrated similar patient reported functional recovery, activity levels, and satisfaction at 2 years of follow-up, as assessed by KOS-ADLS, HAAS, and patient satisfaction scores. KOS–ADLS scores in both groups were 90 points (out of a 100 points). In both groups, these scores were almost doubled compared with the baseline (UKR, 40; TKR, 43) scores. Lombardi et al. [42] reported improved functional recovery during early follow-up in matched patients who underwent UKR compared with those who underwent TKR, but at 2 years postoperatively, both groups had similar patient reported functional outcomes. In their
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retrospective matched patient analysis of databases, Lim et al. [44] and Mathew et al. [45]
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Our study showed that compared with UKR patients, TKR patients had a longer
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at early, mid-, and long-term follow-up. Howell et al. [46] eliminated selection bias by comparing patients who were all selected for UKR, but some of whom to undergo TKR because of intraoperative findings; they reported comparable functional outcomes in both groups. Our study dispels the belief that UKR provides better patient reported functional
improvement in function, activity, and satisfaction.
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outcomes than does TKR. At 2 years of follow-up, both UKR and TKR provided a similar
length of hospital stay and a higher number of complications and readmissions at 2 years of follow-up. These results differed from those of Winder et al. [47], who reported a similar rate
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of early complications at 90 days postoperatively. By contrast, Liddle et al. [48] and Lim, who conducted a large database analysis of more than one lakh patients from the English and Wales registry, reported similar results to ours [25]. A higher postoperative morbidity in TKR
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patients than in UKR patients was revealed through a well-performed meta-analysis by Brown et al. [49]. Similar to our findings, Riff demonstrated that UKR (a minimally invasive surgery) is clearly safer than TKR in terms of mortality and morbidity. Carlos reported a 4% incidence of postoperative complications in UKR patients compared with 11% in TKR patients. Elderly patients with comorbidities who suffer from early knee osteoarthritis disabling enough to require surgical intervention can be offered UKR as a safer option, which provides equivalent
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functional restoration, as does TKR.
The major strength of our study is its randomized design, which we could conducted in an equipoise fashion because the surgical team was experienced in performing both TKR and UKR with equal comfort. Because this was a single-center study conducted in one
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arthroplasty unit, all surgeries were performed using similar surgical techniques, implants, and postoperative protocols. The selection of bilateral cases made outcome analysis easier by eliminating the interference caused by the healthy limb (which may have been variably affected by the arthritis). Our study assessed the change in functional status compared with
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recently reported similar findings of equivalent functional outcomes in UKR and TKR patients
the baseline and not absolute recovery, which reduced the bias introduced through the difference in baseline function. Our study used multiple validated subjective and objective scores, including the assessment of high activity levels, to improve the outcome evaluation. Because this was a military care facility with a dependent population, a more than 90% 2-year follow-up rate was observed. Our study has a few limitations. Our results can only be generalized for applicability in cemented cruciate-substituting fixed-bearing TKR implants and cemented fixed-bearing UKR implants. The patients could not be blinded. However, the outcome assessment was blinded by using a trained physiotherapist who was unaware of the type of surgery performed. As this was an early-outcome study, the midterm failures of UKR, which are reportedly more than those of TKR, could not be assessed. We are currently following up these cohorts to identify
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midterm failures, which we plan to report in a future study. We eagerly await the results of a
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In summary, our study shows that, contrary to common belief, at the 2-year follow-up,
large multi-center trial (TOPKAT), which completed recruitment in 2013 and is presently collecting follow-up data (until 2018); this study will report on functional outcomes, including midterm failures [50].
both UKR and TKR performed for isolated medial compartment arthritis provided similar
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patient reported functional outcomes, activity levels, performance, and satisfaction. However, because of decreased complications, rapid early rehabilitation, and ease of revision, UKR may be a more suitable option for younger patients with isolated medial compartment disease
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BIBLIOGRAPHY
311 312 313 314
[1]
315 316 317
[2]
318 319 320
[3]
321 322 323 324
[4]
325 326 327 328
[5]
329 330 331 332
[6]
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and, similarly, for elderly patients with multiple comorbidities.
O'Donnell T, Neil MJ. The Repicci II® unicondylar knee arthroplasty: 9-year
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survivorship and function. Clin Orthop Relat Res. 2010 Nov;468(11):3094-102. doi: 10.1007/s11999-010-1474-6. Epub 2010 Aug 13. PubMed PMID: 20706814; PubMed Central PMCID: PMC2947673.
Bourne RB. Measuring tools for functional outcomes in total knee arthroplasty. Clin
Orthop Relat Res. 2008 Nov;466(11):2634-8. doi: 10.1007/s11999-008-0468-0. Epub 2008
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Sep 9. PubMed PMID: 18780136; PubMed Central PMCID: PMC2565042. Sutton PM, Holloway ES. The young osteoarthritic knee: dilemmas in management.
BMC Med. 2013 Jan 18;11:14. doi: 10.1186/1741-7015-11-14. PubMed PMID: 23331908; PubMed Central PMCID: PMC3567986.
EP
Von Keudell A, Sodha S, Collins J, Minas T, Fitz W, Gomoll AH. Patient satisfaction
after primary total and unicompartmental knee arthroplasty: an age-dependent analysis.
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Knee. 2014 Jan;21(1):180-4. doi: 10.1016/j.knee.2013.08.004. Epub 2013 Aug 15. PubMed PMID: 24148793.
Panni AS, Vasso M, Cerciello S, Felici A. Unicompartmental knee replacement
provides early clinical and functional improvement stabilizing over time. Knee Surg Sports Traumatol Arthrosc. 2012 Mar;20(3):579-85. doi: 10.1007/s00167-011-1613-y. Epub 2011 Jul 12. PubMed PMID: 21748391. W-Dahl A, Robertsson O, Lidgren L, Miller L, Davidson D, Graves S.
Unicompartmental knee arthroplasty in patients aged less than 65. Acta Orthop. 2010 Feb;81(1):90-4. doi: 10.3109/17453671003587150. PubMed PMID: 20175656; PubMed Central PMCID: PMC2856210.
9
ACCEPTED MANUSCRIPT 333 334 335 336
[7]
337 338 339 340
[8]
341 342 343 344 345
[9]
346 347 348
[10]
349 350 351 352
[11]
353 354 355 356
[12]
357 358 359 360
[13]
361 362 363 364 365
[14]
Newman J, Pydisetty RV, Ackroyd C. Unicompartmental or total knee replacement:
the 15-year results of a prospective randomised controlled trial. J Bone Joint Surg Br. 2009 Jan;91(1):52-7. doi: 10.1302/0301-620X.91B1.20899. Erratum in: J Bone Joint Surg Br. 2009 May;91(5):701. PubMed PMID: 19092004. Newman JH, Ackroyd CE, Shah NA. Unicompartmental or total knee replacement?
Five-year results of a prospective, randomised trial of 102 osteoarthritic knees with
RI PT
unicompartmental arthritis. J Bone Joint Surg Br. 1998 Sep;80(5):862-5. PubMed PMID: 9768899.
Niinimäki T, Eskelinen A, Mäkelä K, Ohtonen P, Puhto AP, Remes V.
Unicompartmental knee arthroplasty survivorship is lower than TKA survivorship: a 27-year registry
study.
Clin
Orthop
Relat
Res.
2014
May;472(5):1496-501.
SC
Finnish
doi:
10.1007/s11999-013-3347-2. Epub 2013 Nov 19. PubMed PMID: 24249531; PubMed Central
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PMCID: PMC3971215.
Collier MB, Eickmann TH, Sukezaki F, McAuley JP, Engh GA. Patient, implant, and
alignment factors associated with revision of medial compartment unicondylar arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):108-15. PubMed PMID: 16950071. Baker P, Jameson S, Critchley R, Reed M, Gregg P, Deehan D. Center and surgeon
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volume influence the revision rate following unicondylar knee replacement: an analysis of 23,400 medial cemented unicondylar knee replacements. J Bone Joint Surg Am. 2013 Apr 17;95(8):702-9. doi: 10.2106/JBJS.L.00520. PubMed PMID: 23595068. Choy WS, Kim KJ, Lee SK, Yang DS, Lee NK. Mid-term results of oxford medial
EP
unicompartmental knee arthroplasty. Clin Orthop Surg. 2011 Sep;3(3):178-83. doi: 10.4055/cios.2011.3.3.178. Epub 2011 Aug 19. PubMed PMID: 21909464; PubMed Central
AC C
PMCID: PMC3162197.
Rodriguez-Merchant EC. Medial Unicompartmental Osteoarthritis (MUO) of the Knee:
Unicompartmental Knee Replacement (UKR) or Total Knee Replacement (TKR). Arch Bone Jt Surg. 2014 Sep;2(3):137-40. Epub 2014 Sep 15. Review. PubMed PMID: 25386571; PubMed Central PMCID: PMC4225015. Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L.
Measuring functional improvement after total knee arthroplasty requires both performancebased and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20. PubMed PMID: 20851566; PubMed Central PMCID: PMC3008304.
10
ACCEPTED MANUSCRIPT 366 367 368 369
[15]
370 371 372
[16]
373 374
[17]
375
10.1016/j.arth.2013.05.025. Epub 2013 Jun 21. PubMed PMID: 23796558.
376 377 378 379
[18]
380 381 382
[19]
383 384 385
[20]
386 387
[21]
388 389 390
[22]
391 392 393
[23]
394 395
[24]
Piva SR, Gil AB, Moore CG, Fitzgerald GK. Responsiveness of the activities of daily
living scale of the knee outcome survey and numeric pain rating scale in patients with patellofemoral pain. J Rehabil Med. 2009 Feb;41(3):129-35. doi: 10.2340/16501977-0295. PubMed PMID: 19229444. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and
Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure.
RI PT
J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. PubMed PMID: 9699158.
Kulshrestha V, Kumar S. DVT prophylaxis after TKA: routine anticoagulation vs risk
SC
screening approach - a randomized study. J Arthroplasty. 2013 Dec;28(10):1868-73. doi:
Backes JR, Bentley JC, Politi JR, Chambers BT. Dexamethasone reduces length of
M AN U
hospitalization and improves postoperative pain and nausea after total joint arthroplasty: a prospective, randomized controlled trial. J Arthroplasty. 2013 Sep;28(8 Suppl):11-7. doi: 10.1016/j.arth.2013.05.041. Epub 2013 Aug 9. PubMed PMID: 23937923. Zeni, J. A., Axe, M. J., & Snyder-Mackler, L. Clinical predictors of elective total joint
replacement in persons with end-stage knee osteoarthritis. BMC Musculoskeletal Disorders. 2010; 11(1), 1–8. http://doi.org/10.1186/1471-2474-11-86
TE D
Talbot, S., Hooper, G., Stokes, A., & Zordan, R. (2016). Use of a New High-Activity
Arthroplasty Score to Assess Function of Young Patients With Total Hip or Knee Arthroplasty. J Arthroplasty. 2016; 25(2), 268–273. http://doi.org/10.1016/j.arth.2008.09.019
EP
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality
of life. Health Policy. 1990 Dec;16(3):199-208. PubMed PMID: 10109801
AC C
Fisher LD, Dixon DO, Herson J, Frankowski RK, Hearron MS, Peace KE. Intention to
treat in clinical trials. In: Peace KE, editor. Statistical issues in drug research and development. New York: Marcel Dekker; 1990. pp. 331–50. Rönn K, Reischl N, Gautier E, Jacobi M. Current surgical treatment of knee
osteoarthritis. Arthritis. 2011;2011:454873. doi: 10.1155/2011/454873. Epub 2011 Apr 26. PubMed PMID: 22046517; PubMed Central PMCID: PMC3200113. Australian Orthopaedic Association National Joint Replacement Registry Annual
Report. 2013.
11
ACCEPTED MANUSCRIPT 396 397
[25]
398
[26]
The Swedish Knee Arthroplasty Register Annual Report. 2012.
399 400 401
[27]
Riff AJ, Sah AP, Della Valle CJ. Outcomes and complications of unicondylar
402 403 404 405
[28]
406 407 408 409
[29]
410 411 412
[30]
413 414 415
[31]
416 417 418
[32]
419 420 421
[33]
422 423
[34]
424 425 426
[35]
National Joint Registry for England, Wales and Northern Ireland 10th Annual
Report. 2013.
arthroplasty. Clin Sports Med. 2014 Jan;33(1):149-60. doi: 10.1016/j.csm.2013.06.005. Epub
RI PT
2013 Aug 28. Review. PubMed PMID: 24274852.
Noticewala MS, Geller JA, Lee JH, Macaulay W. Unicompartmental knee arthroplasty
relieves pain and improves function more than total knee arthroplasty. J Arthroplasty. 2012 Sep;27(8 Suppl):99-105. doi: 10.1016/j.arth.2012.03.044. Epub 2012 May 31. PubMed PMID:
SC
22658232.
Manzotti A, Confalonieri N, Pullen C. Unicompartmental versus computer-assisted
M AN U
total knee replacement for medial compartment knee arthritis: a matched paired study. Int Orthop. 2007 Jun;31(3):315-9. Epub 2006 Aug 2. PubMed PMID: 16896871; PubMed Central PMCID: PMC2267582.
Weale AE, Halabi OA, Jones PW, White SH. Perceptions of outcomes after
unicompartmental and total knee replacements. Clin Orthop Relat Res. 2001 Jan;(382):143-
TE D
53. PubMed PMID: 11153982.
Laurencin CT, Zelicof SB, Scott RD, Ewald FC. Unicompartmental versus total knee
arthroplasty in the same patient. A comparative study. Clin Orthop Relat Res. 1991
EP
Dec;(273):151-6. PubMed PMID: 1959264.
Ackroyd CE, Whitehouse SL, Newman JH, Joslin CC. A comparative study of the
medial St Georg sled and kinematic total knee arthroplasties. Ten-year survivorship. J Bone
AC C
Joint Surg Br. 2002 Jul;84(5):667-72. PubMed PMID: 12188481. Hassaballa MA, Porteous AJ, Learmonth ID. Functional outcomes after different
types of knee arthroplasty: kneeling ability versus descending stairs. Med Sci Monit. 2007 Feb;13(2):CR77-81. PubMed PMID: 17261986. Borus T, Thornhill T. Unicompartmental knee arthroplasty. J Am Acad Orthop Surg.
2008 Jan;16(1):9-18. Review. PubMed PMID: 18180388. Robertsson
O,
Borgquist
L,
Knutson
K,
Lewold
S,
Lidgren
L.
Use
of
unicompartmental instead of tricompartmental prostheses for unicompartmental arthrosis in the knee is a cost-effective alternative. 15,437 primary tricompartmental prostheses were
12
ACCEPTED MANUSCRIPT 427 428
compared with 10,624 primary medial or lateral unicompartmental prostheses. Acta Orthop
429 430 431
[36]
432 433 434
[37]
435 436 437
[38]
438 439 440
[39]
441 442 443
[40]
444 445 446 447 448
[41]
449 450 451 452
[42]
453 454 455
[43]
456 457
[44]
Scand. 1999 Apr;70(2):170-5. PubMed PMID: 10366919. Walton NP, Jahromi I, Lewis PL, Dobson PJ, Angel KR, Campbell DG. Patient-
perceived outcomes and return to sport and work: TKA versus mini-incision unicompartmental knee arthroplasty. J Knee Surg. 2006 Apr;19(2):112-6. PubMed PMID: 16642887.
RI PT
Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and
unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64. PubMed PMID: 1959265.
Amin AK, Patton JT, Cook RE, Gaston M, Brenkel IJ. Unicompartmental or total knee
SC
arthroplasty?: Results from a matched study. Clin Orthop Relat Res. 2006 Oct;451:101-6. PubMed PMID: 16760806.
M AN U
Price AJ, Waite JC, Svard U. Long-term clinical results of the medial Oxford
unicompartmental knee arthroplasty. Clin Orthop Relat Res. 2005 Jun;(435):171-80. PubMed PMID: 15930935.
McAllister CM. The role of unicompartmental knee arthroplasty versus total knee
arthroplasty in providing maximal performance and satisfaction. J Knee Surg. 2008
TE D
Oct;21(4):286-92. Review. PubMed PMID: 18979931.
Nerhus TK, Heir S, Svege I, Skråmm I, Jervidalo T, Madsen JE, Ekeland A. Time-
dependent improvement in functional outcome following Oxford medial unicompartmental knee arthroplasty. A prospective longitudinal multicenter study involving 96 patients. Acta
EP
Orthop. 2012 Feb;83(1):46-52. doi: 10.3109/17453674.2011.652890. Epub 2012 Jan 17. PubMed PMID: 22248171; PubMed Central PMCID: PMC3278657.
AC C
Lombardi AV Jr, Berend KR, Walter CA, Aziz-Jacobo J, Cheney NA. Is recovery
faster for mobile-bearing unicompartmental than total knee arthroplasty? Clin Orthop Relat Res. 2009 Jun;467(6):1450-7. doi: 10.1007/s11999-009-0731-z. Epub 2009 Feb 19. PubMed PMID: 19225852; PubMed Central PMCID: PMC2674171. Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time
course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. PubMed PMID: 16108583. Lim JW, Cousins GR, Clift BA, Ridley D, Johnston LR. Oxford unicompartmental knee
arthroplasty versus age and gender matched total knee arthroplasty - functional outcome and
13
ACCEPTED MANUSCRIPT 458 459
survivorship
460 461 462 463
[45]
464 465 466 467
[46]
468 469 470
[47]
471 472 473 474
[48]
475 476 477 478
[49]
479 480 481 482
[50]
J
Arthroplasty.
2014
Sep;29(9):1779-83.
doi:
10.1016/j.arth.2014.03.043. Epub 2014 Apr 5. PubMed PMID: 24805827. Lyons
MC,
MacDonald
SJ,
Somerville
LE,
Naudie
DD,
McCalden
RW.
Unicompartmental versus total knee arthroplasty database analysis: is there a winner? Clin Orthop Relat Res. 2012 Jan;470(1):84-90. doi: 10.1007/s11999-011-2144-z. PubMed PMID:
RI PT
22038173; PubMed Central PMCID: PMC3237994. Howell RE, Lombardi AV Jr, Crilly R, Opolot S, Berend KR. Unicompartmental Knee
Arthroplasty: Does a Selection Bias Exist? J Arthroplasty. 2015 May 12. pii: S08835403(15)00375-7. doi: 10.1016/j.arth.2015.05.010. [Epub ahead of print] PubMed PMID:
SC
26002297.
Winder RP, Severson EP, Trousdale RT, Pagnano MW, Wood-Wentz CM, Sierra RJ.
No difference in 90-day complications between bilateral unicompartmental and total knee
M AN U
arthroplasty. Am J Orthop (Belle Mead NJ). 2014 Feb;43(2):E30-3. PubMed PMID: 24551868. Liddle AD, Judge A, Pandit H, Murray DW. Adverse outcomes after total and
unicompartmental knee replacement in 101,330 matched patients: a study of data from the National Joint Registry for England and Wales. Lancet. 2014 Oct 18; 384(9952):1437-45. Erratum in: Lancet. 2015 Feb 28;385(9970):774. PubMed PMID: 25012116.
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Brown NM, Sheth NP, Davis K, Berend ME, Lombardi AV, Berend KR, et al. Total
knee arthroplasty has higher postoperative morbidity than unicompartmental knee arthroplasty: a multicenter analysis. J Arthroplasty. 2012 Sep;27(8 Suppl):86-90. doi:
EP
10.1016/j.arth.2012.03.022. Epub 2012 May 4. PubMed PMID: 22560653. Beard D, Price A, Cook J, Fitzpatrick R, Carr A, Campbell M, et al. Total or Partial
Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial. Trials. 2013 Sep 12;14:292. doi: 10.1186/1745-6215-14-292. PubMed PMID: 24028414; PubMed
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483
analysis.
Central PMCID: PMC3848560.
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ACCEPTED MANUSCRIPT Acknowledgments: The authors would like to thank Mr Balwant & Mr Kamalnath (Research Assistants) and Miss Hemlata (Physiotherapist) for their valuable contributions in data collection and outcome assessment without which this study would not have been possible.
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Financial Disclosures: No financial support received from any agency.
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Table 2 Pre-Operative function, performance & satisfaction
SD
n
36
116
8.9
36
113
11.1
0.1015
0.30
t-test
KOS-ADLS (Max 100)
c
36
40.4
9.0
36
42.9
12.7
0.1725
0.23
t-test
Oxford Score
36
24.8
6.2
36
23.2
7.1
0.2241
0.24
t-test
HAASd
36
9.1
2.2
36
8.9
2.5
0.5619
0.08
t-test
Time Up & Go (Sec)
36
7.7
2.4
36
7.43
2.1
0.2314
0.13
t-test
Stair Climb test (Sec)
36
14.2
6.2
36
13.62
7.8
0.2871
0.09
t-test
Self paced walk test (sec)
36
Chair to stand test (Sec)
36
36`
P-value
Test
26.8
7.6
36
28.4
8.1
0.1764
0.18
t-test
15.4
6.7
36
16.3
7.7
0.1932
0.13
t-test
36.4
11.7
36
34.4
12.5
0.1444
0.17
t-test
33.3
13.9
36
31.4
11.9
0.3331
0.15
t-test
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EQ 5D (VAS)e
36
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Satisfaction (%)
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Delaware Index
SD
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mean
Knee Flexion
mean
Effect size
n
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Parameter
TKRb
SC
UKRa
_________________________________________________________________________________________________________________________ a
UKR = Unicondylar Knee replacement; b TKR = Total Knee Replacement; c KOS –ADLS = Knee Outcome Scale – Activity of Daily Living Scale; dHAAS= High Activity Arthroplasty Score; e EQ5D (VAS)= European Quality of Life index (Visual Analogue Scale)
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Table 1 Pre-Operative demographic and comorbidities
SD
n
mean
years
36
59.72
8.7
36
62.19
Male Female
36 06 30
Gender
BMI
c
d
FCI e ASA Gr I Gr II Gr III Haemoglobin (% %)
36 10 26
36
28.3
3.4
36 36 8 28 0
1.02
1.1
36
12.67
1,26
SD
6.4
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mean
P-value
0.2143
0.15
0.3961
0.34
Fisher's exact
0.29
t-test
27.5
4.3
0.8310
36 36 4 31 1
1.28
1.0
0.4663 0.3431
12.72
1.22
0.5679
36
Effect size
Test Two-sample Wilcoxon rank-sum (MannWhitney) test
36
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Age
n
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Parameter
TKRb
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UKRa
Fisher's exact Fischer exact
t-test 0.34
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__________________________________________________________________________________________________________________________ UKR = Unicondylar Knee replacement; b TKR = Total Knee Replacement; c BMI = Body Mass Index; d FCI = Functional Comorbidity index;
e
ASA = American Society of Anaesthesiologist (grading of anaesthesia risks); f KOS-ADLS = Knee Outcome Score – Activity Of Daily Living Scale
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a
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Table 3 Outcome at Two years follow up (Gain in scores)
n
mean
SD
n
36
4.9
9.1
36
^KOS-ADLS (Max 100)
36
50.0
9.8
36
^HAASd
36
3.1
1.6
36
^Oxford Score
36
17.1
4.1
Time Up & Go (Sec)
36
7.7
2.7
Stair Climb test (Sec)
36
Self paced walk test (sec)
36
Chair to stand test (Sec)
36
c
^EQ 5D (VAS)e
36`
SD
P-value
Effect size
Test
13.5
47.0
13.0
0.2143
0.27
t-test
2.8
1.7
0.2010
0.18
t-test
36
16.8
5.5
36
6.9
2.7
0.7699
0.36
t-test
8.8
3.5
36
7.2
2.9
6.2
3.4
36
4.9
1.7
3.0
0.8
36
2.9
0.7
59.0
8.3
36
55.7
9.9
43.3
13.9
36
39.4
11.8
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^Satisfaction (%)
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^Delaware Index
5.8
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^ Knee Flexion
mean
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Parameter
TKRb
SC
UKRa
_________________________________________________________________________________________________________________________ ^ Gain at 2 yrs of follow up; a UKR = Unicondylar Knee replacement; b TKR = Total Knee Replacement; c KOS –ADLS = Knee Outcome Scale – Activity of Daily Living Scale; dHAAS= High Activity Arthroplasty Score; e EQ5D (VAS)= European Quality of Life index (Visual Analogue Scale)
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Table 4 Complications in Unicondylar (UKR) as against Total Knee Replacement (TKR) group S No.
Complication
Group
No. of Cases
n
%
Respiratory Failure
TKR UKR
40 36
01 00
2.5% 0.0%
2.
Blood transfusion
TKR UKR
40 36
02 00
5.0% 0.0%
3.
Wound Complications
TKR UKR
40 36
02 00
5.0% 0.0%
4.
Periprosthetic fracture
TKR UKR
40 36
01 00
2.5% 0.0%
40 36
01 00
2.5% 0.0%
36 36
02 00
6.0% 0.0%
TKR UKR
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Anterior Knee Pain & crepitus
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TKR UKR
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Stiff Knee 5.
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Legends
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Fig 3 CONSORT diagram of the study
18 19 20 21 22 23 24 25 26 27 28 29 30
Tables
Fig 1 (a) Preoperative plain radiographs of patient with isolated medial compartment arthritis who underwent bilateral Total Knee Replacement
(b & c) Postoperative plain radiographs of the same patient. Standing Hip, knee and ankle radiograph to evaluate limb alignment.
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(d)
Fig 2 (a & b) Preoperative plain radiographs of patient with isolated medial compartment arthritis who underwent bilateral Medial Compartment Unicondylar Knee Replacement.
Standing Hip, knee and ankle radiograph to evaluate limb alignment.
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(d)
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(c) Postoperative plain radiographs of the same patient.
Table 1: Patient demographics including Functional Comorbidity Index (FCI) in bilateral Total
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Knee Replacement & Unicondylar Knee Replacement group.
Table 2 : Baseline patient reported activity, function and performance in bilateral Total Knee Replacement & Unicondylar Knee Replacement group.
Table 3: Patient reported activity, function and performance in bilateral Total Knee
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Replacement & Unicondylar Knee Replacement group at two years of follow up.
Table 4: Complications in Total Knee Replacement as against Unicondylar Knee
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Figures
Replacement group.
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Eligible (100):
1. Patients with bilateral medial compartment arthritis opting for surgery 2. Selected by surgeon as appropriate for simultaneous bilateral TKA/UKA 3. Patient Consenting to undergo UKA/TKA
Enrolled (N= 80 )
Secondary objectives Delaware Index Oxford Score EQ 5D (VAS)
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Baseline KOS ADLS, HAAS, Satisfaction
Random Allocation
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(a) With fixed Varus deformity in any knee (b) More than 10 degree fixed flexion deformity in any knee (c) Suffering from or history of inflammatory / infective joint disease. (d) Have any other lower limb bone or joint pathology. (e) Patellofemoral arthritis with involvement of lateral facet in any knee (f) History of previous surgery on any knee (g) Inability to follow up for the study.
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Excluded (20):
Simultaneous Bilateral UKR n= 40
Simultaneous Bilateral TKR n= 40
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Dropped (04): Per-operatively found to have lateral compartment involvement in one knee and the same was converted to TKA
02 weeks n = 40
Suture removal Clinical assessment (Safety check) Complication review Rehab goals
02 weeks n = 40
Clinical assessment Complication Review ROM and functional goals
24 months n = 36 Clinical assessment Complications KOOS-ADLS /HAAS/Satisfaction Delaware index /Oxford/ EQ5D (VAS) Plain Radiographs
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06 weeks, 3 & 6 month n = 36
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Suture removal Clinical assessment (Safety check) Complication review Rehab goals
06 weeks, 3 & 6 month n = 40 Clinical assessment Complication Review ROM and functional goals
Loss to Follow up = 04
Analysed n = 36
24 months n = 36 Clinical assessment Complications KOOS-ADLS /HAAS/Satisfaction Delaware index /Oxford/ EQ5D (VAS) Plain Radiographs
S0883-5403(16)30899-3
DOI:
10.1016/j.arth.2016.12.014
Reference:
YARTH 55545
To appear in:
The Journal of Arthroplasty
Received Date: 17 August 2016 Revised Date:
1 December 2016
Accepted Date: 12 December 2016
Please cite this article as: Kulshrestha V, Datta B, Kumar S, Mittal G, Outcome of Unicondylar Knee Replacement Versus Total Knee Replacement for Early Medial Compartment Arthritis: A Randomized Study, The Journal of Arthroplasty (2017), doi: 10.1016/j.arth.2016.12.014. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Title: Outcome of Unicondylar Knee Replacement Versus Total Knee Replacement for Early Medial Compartment Arthritis: A Randomized Study
Author :
1.
Vikas Kulshrestha, MS (Orth)*
2.
Barun Datta, MS (Orth) ^
3.
Santhosh Kumar, DNB (Orth)
4.
Gaurav Mittal, MS (Orth)
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Short Title: “Outcomes Bilateral TKR Vs UKR; A Randomized study”
+
#
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* Senior Advisor Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India. Email : [email protected]. +918826292986
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^ Senior Advisor Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India. Email : [email protected] +919818212669 + Classified Specialist Orthopaedics, Department Of Orthopaedics, Air Force Hospital, Jorhat, India. Email : [email protected] +919986663511 #
Graded Specialist Orthopaedics, Joint Replacement Centre, Army Hospital R & R, New Delhi, India. Email: [email protected] +919717393460
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No financial support received from any outside agency.
Research carried out at Army Hospital Research & Referral, New Delhi with institutional resources.
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No conflict of interests
------------------------------------------------------------------------------------------------------
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Corresponding Author :
Dr Vikas Kulshrestha Joint Replacement Centre
Army Hospital Research & Referral Delhi Cantt New Delhi – 110010 Email Id: [email protected] Mobile: +918826292986
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Title: Outcome of Unicondylar Knee Replacement Versus Total Knee Replacement for Early
3
Abstract:
Medial Compartment Arthritis: A Randomized Study
4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Background: With increasing number of patients with early osteoarthritis of knee opting for
23 24
Key Words: unicondylar knee replacement, total knee replacement, patient reported outcome,
27 28 29
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to them would improve outcomes. Methods: Primary objective of our study was to look for any difference in patient reported outcome and function at two year follow up in patients undergoing UKR as compared to TKR. Our study was a randomized study with parallel assignment conducted at a high volume specialized Arthroplasty Centre. Eighty patients with
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bilateral isolated medial compartment knee arthritis were randomized into simultaneous twoteam bilateral TKR (n=40) and UKR (n=40) group. We finally analyzed 36 patients in each group. Main outcome measure was improvement in Knee Outcome Survey – Activity Of Daily
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Living Scale (KOS – ADLS) and High Activity Arthroplasty Score (HAAS) obtained at two-year follow up. Results: Improvement in KOS-ADLS and HAAS at two year was similar (p = 0.2143 & 0.2010) in both groups. Performance as assessed with Delaware index was also similar. Length of hospital stay was less in UKR group (6.6 days as against 5.4 days). Complications and readmission rates were more in TKR group (Nil in UKR group; 08 in TKR group). Conclusion: At two year follow up, UKR provides similar improvement in patient reported outcomes, function and performance as compared to TKR when performed in
complications.
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patients with early arthritis. However, UKR patients have shorter hospital stay and fewer
high activity, performance
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surgical outcomes. It is being presumed that offering Unicondylar Knee Replacement (UKR)
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Total Knee Replacement (TKR) surgery, there has been increase in patients dissatisfied with
30 31 32 33
1
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patients with arthritic knees are opting for total knee replacement (TKR) [1]. An improved surgical technique, safe anesthetic procedures, effective pain control, and accelerated rehabilitation coupled with a modern implant design have ensured predictable outcomes in TKR [2]. Therefore, arthroplasty surgeons are suggesting TKR to patients with early arthritis.
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To avoid pain and maintain the quality of life, even patients are opting for this surgery at an early stage of the disease [3]. However, 15%–20% patients are unsatisfied with their surgical outcome [3,4]. Unicondylar knee replacement (UKR) has excellent functional outcomes with high patient satisfaction, but concern persists regarding its durability and need for revision surgery [5-10]. Because of a limited surgical volume, complex surgical technique, and steep
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learning curve, only a few arthroplasty surgeons are offering this option to their patients [9,11]. More than 30% of patients considered for TKR are candidates for UKR, but only 5% of all knee replacements performed are Unicondylar.
Currently, both procedures remain the
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standard of care for disabling early medial compartmental osteoarthritis. Few studies have shown the superiority of UKR over TKR in terms of early outcomes and functional restoration, whereas others have highlighted their midterm revisions because of technical failures [12,13]. Most of these studies are retrospective cohort studies, which are observational in nature. This study was conducted at a high-volume joint replacement center. Since 2012, two senior fellowship-trained arthroplasty surgeons who perform more than 1000 procedures/year (10% UKR) began offering UKR to patients with disabling early arthritis. This randomized
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Because of its proven success and growing popularity, an increasing number of
study compared the functional outcomes, activity levels, and performance of simultaneous bilateral UKR and TKR in patients with bilateral early medial compartment osteoarthritis. Material and Methods
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Introduction
The study was a single-center, superiority-type randomized trial, in which patients from February 2013 to May 2014 were enrolled after obtaining ethical approval.
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Eligibility: All patients with medial compartment bilateral arthritis who opted for surgery were enrolled in the study after appropriate counseling (Fig. 1, 2). The trial had an equipoise approach because a single operating team consisting of two fellowship-trained arthroplasty surgeons with adequate experience in both fixed-bearing limited-incision UKR and conventional TKR performed all procedures. Surgeons selected suitable patients who could be offered either simultaneous bilateral UKR or TKR and accordingly informed them. Only patients who understood the trial procedure and consented to random selection were recruited after anesthetic clearance. At this stage, the study coordinator in the outpatient department used a computer-generated sequence in a sealed envelope to implement randomization. The patient was informed whether the procedure was a planned UKR or TKR. All
patients
underwent
preoperative
education,
optimization
of
comorbidities,
and
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rehabilitation training. At any time in the trial, patients had the option of choosing the type of
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Inclusion criteria: (a) Medial compartment osteoarthritis with a complete loss of joint space
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Exclusion criteria: (a) Fixed varus deformity in any knee. (b) A more than 10-degree, fixed
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Sample size calculation: According to our literature review, the minimum clinically relevant
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Surgical procedure: As an institutional protocol, all patients who planned to undergo joint
surgery (TKR or UKR). Patients also understood and permitted the operating surgeon to make a final decision regarding UKR or TKR depending on the perioperative findings.
observed on anteroposterior or lateral radiographs of both knees. (b) No clinical or functional anterior cruciate ligament (ACL) laxity in any knee. (c) Radiographically normal lateral
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compartment joint space in both knees. (d) A less than 15-degree, correctable varus deformity in both knees.
flexion deformity in any knee. (c) Currently suffering from or a history of inflammatory/infective
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joint disease. (d) The presence of other lower limb bone or joint pathologies. (e) Patellofemoral arthritis with the involvement of the lateral facet of any knee. (f) A history of
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previous knee surgery. (g) An inability to participate in follow-up.
difference in knee outcome survey–activity of daily living scale (KOS–ADLS) scores is 7.14 points [14-16]. This was considered our primary outcome and was used to calculate the sample size. Because this was a superiority trial, we hypothesized that at 2 years postoperatively, the difference in the mean improvement in KOS–ADLS scores in the simultaneous UKR group compared with in the TKR group would be more than 7.14 points
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[15]. Using Stata Version 12 (StataCorp LP, Texas, USA), we calculated that at a one-sided alpha error of 0.05 and 90% power, 31 patients would be required in each group to obtain significant differences. Taking into account that 10%–15% patients may be lost to follow-up, we planned to enroll 35 patients in each group. We also expected that some patients,
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depending on their perioperative findings, may receive TKR on one side and UKR on the other and would be dropped out from analysis; presuming that this occurs in 10% patients, we
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increased the sample size to 40 in each group.
replacement surgery were advised daily chlorhexidine wash, which was to be initiated at 3 days prior to surgery. Patients were admitted on the evening prior to surgery for undergoing partial preparation, with the overnight use of chlorhexidine wipes. On the evening before surgery, the study nurse, surgeon, and anesthesia resident reconfirmed patient optimization. All diabetic patients were reviewed by an endocrinologist to ensure good perioperative blood glucose
control.
A
color-coded
flag
system
was
used
to
label
patients
with
cardiac/pulmonary/renal/delirium risks. Appropriate risk instructions were carried out in the perioperative period. As pre-emptive pain control, on the morning of surgery a buprenorphine skin patch was applied, and oral drugs, including acetaminophen, a cox-2 selective inhibitor, and gabapentin, were administered. Risk screening for deep vein thrombosis (DVT) was
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ACCEPTED MANUSCRIPT performed on the evening before surgery to plan the combination of chemoprophylaxis (oral aspirin or inj low molecular weight heparin) and mechanical prophylaxis [17]. All surgeries were performed under single-shot spinal anesthesia. At induction, all patients received weight- and comorbidity-adjusted doses of cefazolin or cefuroxime and an aminoglycoside. In all patients one more dose of antibiotic was repeated at 8 h after surgery. All patients received tranexamic acid (1 gm inj.) at induction and one repeated dose at 3 h after surgery. To
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minimize postoperative nausea and vomiting and to improve pain control, dexamethasone (8 mg inj.) was administered at induction and repeated after 24 h [18]. All surgeries in the TKR group were performed through a midline skin incision, followed by a medial parapatellar arthrotomy. All UKR surgeries were performed through a limited medial parapatellar incision, without entering the rectus tendon. All surgeries were simultaneously performed on the right
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and left sides by two surgical teams, but a tourniquet was used only on one side. In patients who planned to undergo UKR, after exposure, the surgeons examined the integrity of the ACL, assessed for any arthritic changes in the lateral knee compartment and lateral
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patellofemoral joint. In case of any evidence of arthritis in these compartments or loss of ACL, the surgery was converted to TKR on one or both sides, depending on the findings. Medial patellofemoral arthritis was ignored while performing UKR. All TKRs were performed using a cemented posterior stabilized implant without patellar resurfacing, and UKRs were performed using a fixed-bearing design. Mechanical alignment principles were applied in TKR by using an intramedullary guide for the femur and an extramedullary guide for the tibial cut. In UKR, an extramedullary guide was used for the tibial cut, and the tibial block technique was used
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for the distal femur cut, without opening the femoral canal. No patellar resurfacing was performed. The arthrotomy was closed using a barbed suture, without the placement of a drain, and all wounds were dressed using silver impregnated hydrocolloid dressing. Postoperatively, the limb was elevated with the knee placed in a flexed position for 24 h. All patients were made to perform regular ankle pumps as soon as the effect of regional
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anesthesia wore off. A pneumatic sequential compression device or electrical stimulation of the calf was used for mechanical prophylaxis. Oral aspirin or low molecular weight heparin was used for chemoprophylaxis, as per the risk score. Patients were ambulated on the first
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postoperative day and were put on an accelerated rehabilitation protocol. Blood transfusion was avoided by not following any transfusion trigger. Effective pain control was achieved through the initiation of pre-emptive multimodal pain medications, which were continued postoperatively. Narcotics and injectable nonsteroidal anti-inflammatory drugs were sparingly used as rescue analgesia. Being a state-sponsored hospital we had an attached rehabilitation center; hence, most patients were discharged at 3–7 days postoperatively after the completion of early rehabilitation goals. Plain anteroposterior and lateral radiographs as well as standing full-length hip, knee, and ankle radiographs were taken to confirm appropriate implant alignment and fixation (Fig. 1, 2). Patients and their caregivers were trained regarding the home rehabilitation program, which focused on pain control, range of movement,
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quadriceps strengthening. and functional mobility. Patients were followed up at 2 and 6 weeks
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Enrolment and Follow-up: Eighty patients with isolated bilateral medial compartment knee
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Statistical Analysis: Statistical analysis was performed using Stata Version 12 (StataCorp LP,
postoperatively for wound care and early rehabilitation.
arthritis were recruited between February 2013 and April 2014; 40 patients each were parallelly assigned into the simultaneous bilateral UKR and TKR groups. After randomization, two patients from the UKR group opted for TKR; however, their results were analyzed in the
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UKR group, in accordance with the intention-to-treat (ITT) principle. Four patients in the UKR group in whom one knee underwent UKR and the other TKR were dropped and not included in analysis. At 2 years postoperatively, the follow-up rate was more than 90%, but four patients in the TKR group could not attend follow-up visits because they relocated. Through telephonic interviews, they reported their level of satisfaction and occurrence of any
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complications; however, KOS–ADLS scoring could not be completed, and the final range of motion could not be recorded so they were dropped from analysis (Fig. 3). Because of random selection, both the TKR and UKR groups were similar in demographics and
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comorbidities (Table 1). The mean age in the UKR group was 59.7 years, which was similar to that in the TKR group (i.e., 62.2 years). The number of females was higher in both groups (UKR: n = 30, 83%; TKR: n = 26, 72%). Most patients were overweight and had an average 2
body mass index of 28 (18–38) kg/m . More than 60% patients in both groups had one or more comorbidities. Except for one, all patients were accepted as ASA I/II in the preanesthetic checkup. The mean preoperative hemoglobin level was more than 12 gm% in both
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groups. The primary outcome measures for the study were KOS-ADLS, high activity arthroplasty score (HAAS), and patient satisfaction. KOS–ADLS is a patient-reported outcome measure specifically designed to assess outcomes after TKR surgery; it is a validated measure of change over time [16]. HAAS is a highly consistent, reproducible, and validated scoring system with the specific advantage of its ability to discriminate the activity level of
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younger patients undergoing TKR without any ceiling effect [19]. In addition, we objectively assessed their performance using the Delaware index [20]. We also recorded the Oxford knee and European Quality of Life index (EQ5D) scores [21]. A trained physiotherapist
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performed the baseline scoring and follow-up assessment. Regarding secondary outcomes, we compared complications, length of hospital stay, readmissions/revision surgery, and final range of movements at 2 years of follow-up (Fig. 3).
Texas, USA). Outcome assessment was performed according to the ITT principle [22]. Patients who received TKR on one side and UKR on the other were excluded from analysis. Patient demographics, including the functional co-morbidity index scores, were compared between the study groups to identify any differences that might confound the outcome comparisons. Mean, standard deviation, and range were presented for continuous parameters. A two-sample independent t-test or nonparametric Mann-Whitney–Wilcoxon test was used to compare continuous variables between the two groups, according to the
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distribution of the variables. The gain in KOS-ADLS, HAAS, and satisfaction at 2 years of
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Results
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KOS–ADLS, HAAS, and Patient satisfaction.
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(Table 2). KOS–ADLS scores in the UKR and TKR groups were 40.4 and 42.9, respectively (p = 0.172). In addition, the HAAS (UKR, 9.1; TKR, 8.9) and preoperative patient satisfaction (UKR, 37.4; TKR, 40.4) scores were similar between the two groups. At the 2-year follow-up, performance was objectively assessed using the Delaware index and was found to be
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comparable between the two groups. The UKR and TKR groups had similar KOS–ADLS scores (90.4 and 89.9, respectively) (; Table 3). At 2 years postoperatively, the mean
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improvement in KOS–ADLS scores in the UKR group was 50 (range, 33–70), which was closely matched by that in TKR group (47; range, 17–74); a mean difference of 3.0 points was documented (p = 0.2143), but this difference was clinically not significant. The gain in HAAS score was very similar between the two groups (UKR, 3.1; TKR, 2.8; p = 0.2010). Preoperatively, patient satisfaction in the UKR group was 37%, which improved to 89% at 2 years; in the TKR group, it improved from 40% to 86%. In addition, the gain in performance (as assessed by Delaware score; Table 3) and the improvement in Oxford and EQ5D scores were similar between the two groups. Surgical details
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Preoperative baseline function and performance were similar between the two groups
The average operative time for the two teams to perform simultaneous bilateral UKR was 65 min (range, 43–105 min), which was similar to that for TKR (56 min; range, 30–83 min). In the UKR group, tibial spine avulsion (n = 1) and a chip fracture of the medial tibia
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Mann-Whitney–Wilcoxon test to identify significant differences between the two groups.
plateau (n = 1), which was fixed using K wires and lag screws, were observed. However, the postoperative protocol was unaltered as fixation was stable. According to DVT risk
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follow-up compared with the values at baseline was subjected to statistical analysis using
assessment, 5 and 11 patients in the UKR and TKR groups received injections of low molecular weight heparin as chemoprophylaxis. The remaining patients received aspirin and mechanical prophylaxis. The length of hospital stay, including early rehabilitation, was significantly less in the UKR group (5.4 days) than that (6.6 days) in the TKR group (p = 0.0212).
Complications and Reoperation In the UKR group, no postoperative complications or readmissions were observed (Table 4). In the postoperative period in the TKR group, one patient experienced respiratory failure secondary to narcotic overdose and was successfully managed with noninvasive ventilation, two underwent blood transfusion for severe anemia, one had peri-prosthetic
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fracture and was readmitted for fixation, one complained of stiff knees at 6 weeks and was
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Discussion
successfully managed with dressing.
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Over the last two decades, TKR has been established as the most successful surgical procedure [1]. Because of its growing popularity and satisfying outcomes, an increasing number of patients with knee osteoarthritis are opting for TKR. Although the surgery is offered to patients with moderate-to-advanced knee arthritis, the threshold for surgery depends on patients’ symptoms and disability [23]. UKR is an established procedure
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for early knee arthritis. Until recently, its use was limited because of questionable longevity [24-26]. Because of a modern implant design, improved surgical technique, and better case selection, a renewed interest in UKR has been observed [27]. Numerous retrospective data
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analyses have reported improved functional outcomes and decreased morbidity and mortality but increased revision rates at midterm follow-up after UKR compared with after TKR [24-26]. Accordingly, surgeons have begun offering UKR to patients with early isolated medial compartment arthritis to improve patient satisfaction after knee replacement. However, the evidence in favor of UKR remains weak because most of the studies are retrospective database reviews [8, 28-40]. Furthermore, most studies have compared absolute outcome scores and not the variation from baseline scores. Many studies also did not match the
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baseline disease severity of the patients undergoing UKR with those undergoing TKR. Most studies have compared unilateral procedures and not considered the extent of disease/disability of the other knee, which would hamper outcome comparisons. Only one randomized study, which was performed 20 years previously [8], has compared the patient reported outcomes of unilateral UKR and TKR, and none have compared the outcomes of the
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and were managed conservatively, and two had delayed wound healing and were
simultaneous bilateral procedure.
This is the first study to assess the subjective outcomes, activity levels, and performance of simultaneous bilateral UKR or TKR in randomly allocated patients. Because it
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readmitted for manipulation, two complained of anterior knee pain with occasional crepitus
is a minimally invasive procedure, UKR provides early recovery of function compared with TKR [41,42]. However, the optimal recovery of function in patients undergoing TKR required 1–2 years [43], according to a comparison of outcomes between the groups. Contrary to findings of multiple database analysis and observational cohort studies [8,28-40], TKR and UKR demonstrated similar patient reported functional recovery, activity levels, and satisfaction at 2 years of follow-up, as assessed by KOS-ADLS, HAAS, and patient satisfaction scores. KOS–ADLS scores in both groups were 90 points (out of a 100 points). In both groups, these scores were almost doubled compared with the baseline (UKR, 40; TKR, 43) scores. Lombardi et al. [42] reported improved functional recovery during early follow-up in matched patients who underwent UKR compared with those who underwent TKR, but at 2 years postoperatively, both groups had similar patient reported functional outcomes. In their
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retrospective matched patient analysis of databases, Lim et al. [44] and Mathew et al. [45]
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Our study showed that compared with UKR patients, TKR patients had a longer
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at early, mid-, and long-term follow-up. Howell et al. [46] eliminated selection bias by comparing patients who were all selected for UKR, but some of whom to undergo TKR because of intraoperative findings; they reported comparable functional outcomes in both groups. Our study dispels the belief that UKR provides better patient reported functional
improvement in function, activity, and satisfaction.
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outcomes than does TKR. At 2 years of follow-up, both UKR and TKR provided a similar
length of hospital stay and a higher number of complications and readmissions at 2 years of follow-up. These results differed from those of Winder et al. [47], who reported a similar rate
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of early complications at 90 days postoperatively. By contrast, Liddle et al. [48] and Lim, who conducted a large database analysis of more than one lakh patients from the English and Wales registry, reported similar results to ours [25]. A higher postoperative morbidity in TKR
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patients than in UKR patients was revealed through a well-performed meta-analysis by Brown et al. [49]. Similar to our findings, Riff demonstrated that UKR (a minimally invasive surgery) is clearly safer than TKR in terms of mortality and morbidity. Carlos reported a 4% incidence of postoperative complications in UKR patients compared with 11% in TKR patients. Elderly patients with comorbidities who suffer from early knee osteoarthritis disabling enough to require surgical intervention can be offered UKR as a safer option, which provides equivalent
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functional restoration, as does TKR.
The major strength of our study is its randomized design, which we could conducted in an equipoise fashion because the surgical team was experienced in performing both TKR and UKR with equal comfort. Because this was a single-center study conducted in one
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arthroplasty unit, all surgeries were performed using similar surgical techniques, implants, and postoperative protocols. The selection of bilateral cases made outcome analysis easier by eliminating the interference caused by the healthy limb (which may have been variably affected by the arthritis). Our study assessed the change in functional status compared with
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recently reported similar findings of equivalent functional outcomes in UKR and TKR patients
the baseline and not absolute recovery, which reduced the bias introduced through the difference in baseline function. Our study used multiple validated subjective and objective scores, including the assessment of high activity levels, to improve the outcome evaluation. Because this was a military care facility with a dependent population, a more than 90% 2-year follow-up rate was observed. Our study has a few limitations. Our results can only be generalized for applicability in cemented cruciate-substituting fixed-bearing TKR implants and cemented fixed-bearing UKR implants. The patients could not be blinded. However, the outcome assessment was blinded by using a trained physiotherapist who was unaware of the type of surgery performed. As this was an early-outcome study, the midterm failures of UKR, which are reportedly more than those of TKR, could not be assessed. We are currently following up these cohorts to identify
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midterm failures, which we plan to report in a future study. We eagerly await the results of a
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In summary, our study shows that, contrary to common belief, at the 2-year follow-up,
large multi-center trial (TOPKAT), which completed recruitment in 2013 and is presently collecting follow-up data (until 2018); this study will report on functional outcomes, including midterm failures [50].
both UKR and TKR performed for isolated medial compartment arthritis provided similar
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patient reported functional outcomes, activity levels, performance, and satisfaction. However, because of decreased complications, rapid early rehabilitation, and ease of revision, UKR may be a more suitable option for younger patients with isolated medial compartment disease
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BIBLIOGRAPHY
311 312 313 314
[1]
315 316 317
[2]
318 319 320
[3]
321 322 323 324
[4]
325 326 327 328
[5]
329 330 331 332
[6]
SC
and, similarly, for elderly patients with multiple comorbidities.
O'Donnell T, Neil MJ. The Repicci II® unicondylar knee arthroplasty: 9-year
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survivorship and function. Clin Orthop Relat Res. 2010 Nov;468(11):3094-102. doi: 10.1007/s11999-010-1474-6. Epub 2010 Aug 13. PubMed PMID: 20706814; PubMed Central PMCID: PMC2947673.
Bourne RB. Measuring tools for functional outcomes in total knee arthroplasty. Clin
Orthop Relat Res. 2008 Nov;466(11):2634-8. doi: 10.1007/s11999-008-0468-0. Epub 2008
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Sep 9. PubMed PMID: 18780136; PubMed Central PMCID: PMC2565042. Sutton PM, Holloway ES. The young osteoarthritic knee: dilemmas in management.
BMC Med. 2013 Jan 18;11:14. doi: 10.1186/1741-7015-11-14. PubMed PMID: 23331908; PubMed Central PMCID: PMC3567986.
EP
Von Keudell A, Sodha S, Collins J, Minas T, Fitz W, Gomoll AH. Patient satisfaction
after primary total and unicompartmental knee arthroplasty: an age-dependent analysis.
AC C
Knee. 2014 Jan;21(1):180-4. doi: 10.1016/j.knee.2013.08.004. Epub 2013 Aug 15. PubMed PMID: 24148793.
Panni AS, Vasso M, Cerciello S, Felici A. Unicompartmental knee replacement
provides early clinical and functional improvement stabilizing over time. Knee Surg Sports Traumatol Arthrosc. 2012 Mar;20(3):579-85. doi: 10.1007/s00167-011-1613-y. Epub 2011 Jul 12. PubMed PMID: 21748391. W-Dahl A, Robertsson O, Lidgren L, Miller L, Davidson D, Graves S.
Unicompartmental knee arthroplasty in patients aged less than 65. Acta Orthop. 2010 Feb;81(1):90-4. doi: 10.3109/17453671003587150. PubMed PMID: 20175656; PubMed Central PMCID: PMC2856210.
9
ACCEPTED MANUSCRIPT 333 334 335 336
[7]
337 338 339 340
[8]
341 342 343 344 345
[9]
346 347 348
[10]
349 350 351 352
[11]
353 354 355 356
[12]
357 358 359 360
[13]
361 362 363 364 365
[14]
Newman J, Pydisetty RV, Ackroyd C. Unicompartmental or total knee replacement:
the 15-year results of a prospective randomised controlled trial. J Bone Joint Surg Br. 2009 Jan;91(1):52-7. doi: 10.1302/0301-620X.91B1.20899. Erratum in: J Bone Joint Surg Br. 2009 May;91(5):701. PubMed PMID: 19092004. Newman JH, Ackroyd CE, Shah NA. Unicompartmental or total knee replacement?
Five-year results of a prospective, randomised trial of 102 osteoarthritic knees with
RI PT
unicompartmental arthritis. J Bone Joint Surg Br. 1998 Sep;80(5):862-5. PubMed PMID: 9768899.
Niinimäki T, Eskelinen A, Mäkelä K, Ohtonen P, Puhto AP, Remes V.
Unicompartmental knee arthroplasty survivorship is lower than TKA survivorship: a 27-year registry
study.
Clin
Orthop
Relat
Res.
2014
May;472(5):1496-501.
SC
Finnish
doi:
10.1007/s11999-013-3347-2. Epub 2013 Nov 19. PubMed PMID: 24249531; PubMed Central
M AN U
PMCID: PMC3971215.
Collier MB, Eickmann TH, Sukezaki F, McAuley JP, Engh GA. Patient, implant, and
alignment factors associated with revision of medial compartment unicondylar arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):108-15. PubMed PMID: 16950071. Baker P, Jameson S, Critchley R, Reed M, Gregg P, Deehan D. Center and surgeon
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volume influence the revision rate following unicondylar knee replacement: an analysis of 23,400 medial cemented unicondylar knee replacements. J Bone Joint Surg Am. 2013 Apr 17;95(8):702-9. doi: 10.2106/JBJS.L.00520. PubMed PMID: 23595068. Choy WS, Kim KJ, Lee SK, Yang DS, Lee NK. Mid-term results of oxford medial
EP
unicompartmental knee arthroplasty. Clin Orthop Surg. 2011 Sep;3(3):178-83. doi: 10.4055/cios.2011.3.3.178. Epub 2011 Aug 19. PubMed PMID: 21909464; PubMed Central
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PMCID: PMC3162197.
Rodriguez-Merchant EC. Medial Unicompartmental Osteoarthritis (MUO) of the Knee:
Unicompartmental Knee Replacement (UKR) or Total Knee Replacement (TKR). Arch Bone Jt Surg. 2014 Sep;2(3):137-40. Epub 2014 Sep 15. Review. PubMed PMID: 25386571; PubMed Central PMCID: PMC4225015. Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L.
Measuring functional improvement after total knee arthroplasty requires both performancebased and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20. PubMed PMID: 20851566; PubMed Central PMCID: PMC3008304.
10
ACCEPTED MANUSCRIPT 366 367 368 369
[15]
370 371 372
[16]
373 374
[17]
375
10.1016/j.arth.2013.05.025. Epub 2013 Jun 21. PubMed PMID: 23796558.
376 377 378 379
[18]
380 381 382
[19]
383 384 385
[20]
386 387
[21]
388 389 390
[22]
391 392 393
[23]
394 395
[24]
Piva SR, Gil AB, Moore CG, Fitzgerald GK. Responsiveness of the activities of daily
living scale of the knee outcome survey and numeric pain rating scale in patients with patellofemoral pain. J Rehabil Med. 2009 Feb;41(3):129-35. doi: 10.2340/16501977-0295. PubMed PMID: 19229444. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and
Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure.
RI PT
J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. PubMed PMID: 9699158.
Kulshrestha V, Kumar S. DVT prophylaxis after TKA: routine anticoagulation vs risk
SC
screening approach - a randomized study. J Arthroplasty. 2013 Dec;28(10):1868-73. doi:
Backes JR, Bentley JC, Politi JR, Chambers BT. Dexamethasone reduces length of
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hospitalization and improves postoperative pain and nausea after total joint arthroplasty: a prospective, randomized controlled trial. J Arthroplasty. 2013 Sep;28(8 Suppl):11-7. doi: 10.1016/j.arth.2013.05.041. Epub 2013 Aug 9. PubMed PMID: 23937923. Zeni, J. A., Axe, M. J., & Snyder-Mackler, L. Clinical predictors of elective total joint
replacement in persons with end-stage knee osteoarthritis. BMC Musculoskeletal Disorders. 2010; 11(1), 1–8. http://doi.org/10.1186/1471-2474-11-86
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Talbot, S., Hooper, G., Stokes, A., & Zordan, R. (2016). Use of a New High-Activity
Arthroplasty Score to Assess Function of Young Patients With Total Hip or Knee Arthroplasty. J Arthroplasty. 2016; 25(2), 268–273. http://doi.org/10.1016/j.arth.2008.09.019
EP
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality
of life. Health Policy. 1990 Dec;16(3):199-208. PubMed PMID: 10109801
AC C
Fisher LD, Dixon DO, Herson J, Frankowski RK, Hearron MS, Peace KE. Intention to
treat in clinical trials. In: Peace KE, editor. Statistical issues in drug research and development. New York: Marcel Dekker; 1990. pp. 331–50. Rönn K, Reischl N, Gautier E, Jacobi M. Current surgical treatment of knee
osteoarthritis. Arthritis. 2011;2011:454873. doi: 10.1155/2011/454873. Epub 2011 Apr 26. PubMed PMID: 22046517; PubMed Central PMCID: PMC3200113. Australian Orthopaedic Association National Joint Replacement Registry Annual
Report. 2013.
11
ACCEPTED MANUSCRIPT 396 397
[25]
398
[26]
The Swedish Knee Arthroplasty Register Annual Report. 2012.
399 400 401
[27]
Riff AJ, Sah AP, Della Valle CJ. Outcomes and complications of unicondylar
402 403 404 405
[28]
406 407 408 409
[29]
410 411 412
[30]
413 414 415
[31]
416 417 418
[32]
419 420 421
[33]
422 423
[34]
424 425 426
[35]
National Joint Registry for England, Wales and Northern Ireland 10th Annual
Report. 2013.
arthroplasty. Clin Sports Med. 2014 Jan;33(1):149-60. doi: 10.1016/j.csm.2013.06.005. Epub
RI PT
2013 Aug 28. Review. PubMed PMID: 24274852.
Noticewala MS, Geller JA, Lee JH, Macaulay W. Unicompartmental knee arthroplasty
relieves pain and improves function more than total knee arthroplasty. J Arthroplasty. 2012 Sep;27(8 Suppl):99-105. doi: 10.1016/j.arth.2012.03.044. Epub 2012 May 31. PubMed PMID:
SC
22658232.
Manzotti A, Confalonieri N, Pullen C. Unicompartmental versus computer-assisted
M AN U
total knee replacement for medial compartment knee arthritis: a matched paired study. Int Orthop. 2007 Jun;31(3):315-9. Epub 2006 Aug 2. PubMed PMID: 16896871; PubMed Central PMCID: PMC2267582.
Weale AE, Halabi OA, Jones PW, White SH. Perceptions of outcomes after
unicompartmental and total knee replacements. Clin Orthop Relat Res. 2001 Jan;(382):143-
TE D
53. PubMed PMID: 11153982.
Laurencin CT, Zelicof SB, Scott RD, Ewald FC. Unicompartmental versus total knee
arthroplasty in the same patient. A comparative study. Clin Orthop Relat Res. 1991
EP
Dec;(273):151-6. PubMed PMID: 1959264.
Ackroyd CE, Whitehouse SL, Newman JH, Joslin CC. A comparative study of the
medial St Georg sled and kinematic total knee arthroplasties. Ten-year survivorship. J Bone
AC C
Joint Surg Br. 2002 Jul;84(5):667-72. PubMed PMID: 12188481. Hassaballa MA, Porteous AJ, Learmonth ID. Functional outcomes after different
types of knee arthroplasty: kneeling ability versus descending stairs. Med Sci Monit. 2007 Feb;13(2):CR77-81. PubMed PMID: 17261986. Borus T, Thornhill T. Unicompartmental knee arthroplasty. J Am Acad Orthop Surg.
2008 Jan;16(1):9-18. Review. PubMed PMID: 18180388. Robertsson
O,
Borgquist
L,
Knutson
K,
Lewold
S,
Lidgren
L.
Use
of
unicompartmental instead of tricompartmental prostheses for unicompartmental arthrosis in the knee is a cost-effective alternative. 15,437 primary tricompartmental prostheses were
12
ACCEPTED MANUSCRIPT 427 428
compared with 10,624 primary medial or lateral unicompartmental prostheses. Acta Orthop
429 430 431
[36]
432 433 434
[37]
435 436 437
[38]
438 439 440
[39]
441 442 443
[40]
444 445 446 447 448
[41]
449 450 451 452
[42]
453 454 455
[43]
456 457
[44]
Scand. 1999 Apr;70(2):170-5. PubMed PMID: 10366919. Walton NP, Jahromi I, Lewis PL, Dobson PJ, Angel KR, Campbell DG. Patient-
perceived outcomes and return to sport and work: TKA versus mini-incision unicompartmental knee arthroplasty. J Knee Surg. 2006 Apr;19(2):112-6. PubMed PMID: 16642887.
RI PT
Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and
unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64. PubMed PMID: 1959265.
Amin AK, Patton JT, Cook RE, Gaston M, Brenkel IJ. Unicompartmental or total knee
SC
arthroplasty?: Results from a matched study. Clin Orthop Relat Res. 2006 Oct;451:101-6. PubMed PMID: 16760806.
M AN U
Price AJ, Waite JC, Svard U. Long-term clinical results of the medial Oxford
unicompartmental knee arthroplasty. Clin Orthop Relat Res. 2005 Jun;(435):171-80. PubMed PMID: 15930935.
McAllister CM. The role of unicompartmental knee arthroplasty versus total knee
arthroplasty in providing maximal performance and satisfaction. J Knee Surg. 2008
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Oct;21(4):286-92. Review. PubMed PMID: 18979931.
Nerhus TK, Heir S, Svege I, Skråmm I, Jervidalo T, Madsen JE, Ekeland A. Time-
dependent improvement in functional outcome following Oxford medial unicompartmental knee arthroplasty. A prospective longitudinal multicenter study involving 96 patients. Acta
EP
Orthop. 2012 Feb;83(1):46-52. doi: 10.3109/17453674.2011.652890. Epub 2012 Jan 17. PubMed PMID: 22248171; PubMed Central PMCID: PMC3278657.
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Lombardi AV Jr, Berend KR, Walter CA, Aziz-Jacobo J, Cheney NA. Is recovery
faster for mobile-bearing unicompartmental than total knee arthroplasty? Clin Orthop Relat Res. 2009 Jun;467(6):1450-7. doi: 10.1007/s11999-009-0731-z. Epub 2009 Feb 19. PubMed PMID: 19225852; PubMed Central PMCID: PMC2674171. Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time
course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. PubMed PMID: 16108583. Lim JW, Cousins GR, Clift BA, Ridley D, Johnston LR. Oxford unicompartmental knee
arthroplasty versus age and gender matched total knee arthroplasty - functional outcome and
13
ACCEPTED MANUSCRIPT 458 459
survivorship
460 461 462 463
[45]
464 465 466 467
[46]
468 469 470
[47]
471 472 473 474
[48]
475 476 477 478
[49]
479 480 481 482
[50]
J
Arthroplasty.
2014
Sep;29(9):1779-83.
doi:
10.1016/j.arth.2014.03.043. Epub 2014 Apr 5. PubMed PMID: 24805827. Lyons
MC,
MacDonald
SJ,
Somerville
LE,
Naudie
DD,
McCalden
RW.
Unicompartmental versus total knee arthroplasty database analysis: is there a winner? Clin Orthop Relat Res. 2012 Jan;470(1):84-90. doi: 10.1007/s11999-011-2144-z. PubMed PMID:
RI PT
22038173; PubMed Central PMCID: PMC3237994. Howell RE, Lombardi AV Jr, Crilly R, Opolot S, Berend KR. Unicompartmental Knee
Arthroplasty: Does a Selection Bias Exist? J Arthroplasty. 2015 May 12. pii: S08835403(15)00375-7. doi: 10.1016/j.arth.2015.05.010. [Epub ahead of print] PubMed PMID:
SC
26002297.
Winder RP, Severson EP, Trousdale RT, Pagnano MW, Wood-Wentz CM, Sierra RJ.
No difference in 90-day complications between bilateral unicompartmental and total knee
M AN U
arthroplasty. Am J Orthop (Belle Mead NJ). 2014 Feb;43(2):E30-3. PubMed PMID: 24551868. Liddle AD, Judge A, Pandit H, Murray DW. Adverse outcomes after total and
unicompartmental knee replacement in 101,330 matched patients: a study of data from the National Joint Registry for England and Wales. Lancet. 2014 Oct 18; 384(9952):1437-45. Erratum in: Lancet. 2015 Feb 28;385(9970):774. PubMed PMID: 25012116.
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Brown NM, Sheth NP, Davis K, Berend ME, Lombardi AV, Berend KR, et al. Total
knee arthroplasty has higher postoperative morbidity than unicompartmental knee arthroplasty: a multicenter analysis. J Arthroplasty. 2012 Sep;27(8 Suppl):86-90. doi:
EP
10.1016/j.arth.2012.03.022. Epub 2012 May 4. PubMed PMID: 22560653. Beard D, Price A, Cook J, Fitzpatrick R, Carr A, Campbell M, et al. Total or Partial
Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial. Trials. 2013 Sep 12;14:292. doi: 10.1186/1745-6215-14-292. PubMed PMID: 24028414; PubMed
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analysis.
Central PMCID: PMC3848560.
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ACCEPTED MANUSCRIPT Acknowledgments: The authors would like to thank Mr Balwant & Mr Kamalnath (Research Assistants) and Miss Hemlata (Physiotherapist) for their valuable contributions in data collection and outcome assessment without which this study would not have been possible.
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Financial Disclosures: No financial support received from any agency.
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Table 2 Pre-Operative function, performance & satisfaction
SD
n
36
116
8.9
36
113
11.1
0.1015
0.30
t-test
KOS-ADLS (Max 100)
c
36
40.4
9.0
36
42.9
12.7
0.1725
0.23
t-test
Oxford Score
36
24.8
6.2
36
23.2
7.1
0.2241
0.24
t-test
HAASd
36
9.1
2.2
36
8.9
2.5
0.5619
0.08
t-test
Time Up & Go (Sec)
36
7.7
2.4
36
7.43
2.1
0.2314
0.13
t-test
Stair Climb test (Sec)
36
14.2
6.2
36
13.62
7.8
0.2871
0.09
t-test
Self paced walk test (sec)
36
Chair to stand test (Sec)
36
36`
P-value
Test
26.8
7.6
36
28.4
8.1
0.1764
0.18
t-test
15.4
6.7
36
16.3
7.7
0.1932
0.13
t-test
36.4
11.7
36
34.4
12.5
0.1444
0.17
t-test
33.3
13.9
36
31.4
11.9
0.3331
0.15
t-test
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EQ 5D (VAS)e
36
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Satisfaction (%)
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Delaware Index
SD
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mean
Knee Flexion
mean
Effect size
n
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Parameter
TKRb
SC
UKRa
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UKR = Unicondylar Knee replacement; b TKR = Total Knee Replacement; c KOS –ADLS = Knee Outcome Scale – Activity of Daily Living Scale; dHAAS= High Activity Arthroplasty Score; e EQ5D (VAS)= European Quality of Life index (Visual Analogue Scale)
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Table 1 Pre-Operative demographic and comorbidities
SD
n
mean
years
36
59.72
8.7
36
62.19
Male Female
36 06 30
Gender
BMI
c
d
FCI e ASA Gr I Gr II Gr III Haemoglobin (% %)
36 10 26
36
28.3
3.4
36 36 8 28 0
1.02
1.1
36
12.67
1,26
SD
6.4
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mean
P-value
0.2143
0.15
0.3961
0.34
Fisher's exact
0.29
t-test
27.5
4.3
0.8310
36 36 4 31 1
1.28
1.0
0.4663 0.3431
12.72
1.22
0.5679
36
Effect size
Test Two-sample Wilcoxon rank-sum (MannWhitney) test
36
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Age
n
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TKRb
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UKRa
Fisher's exact Fischer exact
t-test 0.34
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__________________________________________________________________________________________________________________________ UKR = Unicondylar Knee replacement; b TKR = Total Knee Replacement; c BMI = Body Mass Index; d FCI = Functional Comorbidity index;
e
ASA = American Society of Anaesthesiologist (grading of anaesthesia risks); f KOS-ADLS = Knee Outcome Score – Activity Of Daily Living Scale
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Table 3 Outcome at Two years follow up (Gain in scores)
n
mean
SD
n
36
4.9
9.1
36
^KOS-ADLS (Max 100)
36
50.0
9.8
36
^HAASd
36
3.1
1.6
36
^Oxford Score
36
17.1
4.1
Time Up & Go (Sec)
36
7.7
2.7
Stair Climb test (Sec)
36
Self paced walk test (sec)
36
Chair to stand test (Sec)
36
c
^EQ 5D (VAS)e
36`
SD
P-value
Effect size
Test
13.5
47.0
13.0
0.2143
0.27
t-test
2.8
1.7
0.2010
0.18
t-test
36
16.8
5.5
36
6.9
2.7
0.7699
0.36
t-test
8.8
3.5
36
7.2
2.9
6.2
3.4
36
4.9
1.7
3.0
0.8
36
2.9
0.7
59.0
8.3
36
55.7
9.9
43.3
13.9
36
39.4
11.8
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^Satisfaction (%)
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^Delaware Index
5.8
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^ Knee Flexion
mean
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Parameter
TKRb
SC
UKRa
_________________________________________________________________________________________________________________________ ^ Gain at 2 yrs of follow up; a UKR = Unicondylar Knee replacement; b TKR = Total Knee Replacement; c KOS –ADLS = Knee Outcome Scale – Activity of Daily Living Scale; dHAAS= High Activity Arthroplasty Score; e EQ5D (VAS)= European Quality of Life index (Visual Analogue Scale)
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Table 4 Complications in Unicondylar (UKR) as against Total Knee Replacement (TKR) group S No.
Complication
Group
No. of Cases
n
%
Respiratory Failure
TKR UKR
40 36
01 00
2.5% 0.0%
2.
Blood transfusion
TKR UKR
40 36
02 00
5.0% 0.0%
3.
Wound Complications
TKR UKR
40 36
02 00
5.0% 0.0%
4.
Periprosthetic fracture
TKR UKR
40 36
01 00
2.5% 0.0%
40 36
01 00
2.5% 0.0%
36 36
02 00
6.0% 0.0%
TKR UKR
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TKR UKR
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Legends
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Fig 3 CONSORT diagram of the study
18 19 20 21 22 23 24 25 26 27 28 29 30
Tables
Fig 1 (a) Preoperative plain radiographs of patient with isolated medial compartment arthritis who underwent bilateral Total Knee Replacement
(b & c) Postoperative plain radiographs of the same patient. Standing Hip, knee and ankle radiograph to evaluate limb alignment.
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Fig 2 (a & b) Preoperative plain radiographs of patient with isolated medial compartment arthritis who underwent bilateral Medial Compartment Unicondylar Knee Replacement.
Standing Hip, knee and ankle radiograph to evaluate limb alignment.
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(d)
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(c) Postoperative plain radiographs of the same patient.
Table 1: Patient demographics including Functional Comorbidity Index (FCI) in bilateral Total
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Knee Replacement & Unicondylar Knee Replacement group.
Table 2 : Baseline patient reported activity, function and performance in bilateral Total Knee Replacement & Unicondylar Knee Replacement group.
Table 3: Patient reported activity, function and performance in bilateral Total Knee
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Replacement & Unicondylar Knee Replacement group at two years of follow up.
Table 4: Complications in Total Knee Replacement as against Unicondylar Knee
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Figures
Replacement group.
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Eligible (100):
1. Patients with bilateral medial compartment arthritis opting for surgery 2. Selected by surgeon as appropriate for simultaneous bilateral TKA/UKA 3. Patient Consenting to undergo UKA/TKA
Enrolled (N= 80 )
Secondary objectives Delaware Index Oxford Score EQ 5D (VAS)
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Baseline KOS ADLS, HAAS, Satisfaction
Random Allocation
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(a) With fixed Varus deformity in any knee (b) More than 10 degree fixed flexion deformity in any knee (c) Suffering from or history of inflammatory / infective joint disease. (d) Have any other lower limb bone or joint pathology. (e) Patellofemoral arthritis with involvement of lateral facet in any knee (f) History of previous surgery on any knee (g) Inability to follow up for the study.
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Excluded (20):
Simultaneous Bilateral UKR n= 40
Simultaneous Bilateral TKR n= 40
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Dropped (04): Per-operatively found to have lateral compartment involvement in one knee and the same was converted to TKA
02 weeks n = 40
Suture removal Clinical assessment (Safety check) Complication review Rehab goals
02 weeks n = 40
Clinical assessment Complication Review ROM and functional goals
24 months n = 36 Clinical assessment Complications KOOS-ADLS /HAAS/Satisfaction Delaware index /Oxford/ EQ5D (VAS) Plain Radiographs
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06 weeks, 3 & 6 month n = 36
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Suture removal Clinical assessment (Safety check) Complication review Rehab goals
06 weeks, 3 & 6 month n = 40 Clinical assessment Complication Review ROM and functional goals
Loss to Follow up = 04
Analysed n = 36
24 months n = 36 Clinical assessment Complications KOOS-ADLS /HAAS/Satisfaction Delaware index /Oxford/ EQ5D (VAS) Plain Radiographs