Femoral Stem Survivorship in Dorr Type A Femurs After Total Hip Arthroplasty Using a Cementless Tapered Wedge Stem: A Matched Comparative Study With Type B Femurs

Femoral Stem Survivorship in Dorr Type A Femurs After Total Hip Arthroplasty Using a Cementless Tapered Wedge Stem: A Matched Comparative Study With Type B Femurs

Accepted Manuscript Femoral Stem Survivorship in Dorr Type A Femurs Following Total Hip Arthroplasty Using a Cementless Tapered Wedge Stem: A Matched ...

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Accepted Manuscript Femoral Stem Survivorship in Dorr Type A Femurs Following Total Hip Arthroplasty Using a Cementless Tapered Wedge Stem: A Matched Comparative Study with Type B Femurs Chan-Woo Park, MD, Hyeon-Jun Eun, MD, Sung-Hak Oh, MD, Hyun-Jun Kim, MD, Seung-Jae Lim, MD, Youn-Soo Park, MD PII:

S0883-5403(18)31117-3

DOI:

https://doi.org/10.1016/j.arth.2018.11.004

Reference:

YARTH 56900

To appear in:

The Journal of Arthroplasty

Received Date: 19 September 2018 Revised Date:

16 October 2018

Accepted Date: 2 November 2018

Please cite this article as: Park C-W, Eun H-J, Oh S-H, Kim H-J, Lim S-J, Park Y-S, Femoral Stem Survivorship in Dorr Type A Femurs Following Total Hip Arthroplasty Using a Cementless Tapered Wedge Stem: A Matched Comparative Study with Type B Femurs, The Journal of Arthroplasty (2018), doi: https://doi.org/10.1016/j.arth.2018.11.004. 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.

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Femoral Stem Survivorship in Dorr Type A Femurs Following Total Hip Arthroplasty Using a

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Cementless Tapered Wedge Stem: A Matched Comparative Study with Type B Femurs

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Chan-Woo Park, MD, Hyeon-Jun Eun, MD, Sung-Hak Oh, MD, Hyun-Jun Kim, MD, Seung-Jae

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Lim, MD, Youn-Soo Park, MD

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Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of

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Medicine, Seoul, Korea

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Concise Title: Stem Survivorship in Dorr Type A Femurs Following Primary THA

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Please address all correspondence to:

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Youn-Soo Park, MD

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Department of Orthopedic Surgery, Samsung Medical Center

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81 Irwon-ro, Gangnam-gu

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Seoul 06351

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South Korea.

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Phone: 82-2-3410-3504

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Fax: 82-2-3410-0061

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Email: [email protected]

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Femoral Stem Survivorship in Dorr Type A Femurs Following Total Hip Arthroplasty Using a

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Cementless Tapered Wedge Stem: A Matched Comparative Study with Type B Femurs

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Abstract

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Background: There is a lack of understanding on relationship between the femoral geometry and outcomes of total hip

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arthroplasty (THA). We investigated clinical and radiographic outcomes of THA using a cementless tapered

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wedge stem in patients with Dorr type A proximal femoral morphology, and compared with those of type B

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femurs at a minimum follow-up of 5 years.

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Methods:

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We analyzed 1089 hips (876 patients) that underwent THA using an identical cementless tapered wedge

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stem. We divided all femurs into 3 types (Dorr type A, B and C). Type A and B femurs were statistically

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matched with age, gender, body mass index and diagnosis by using propensity score matching. Clinical,

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radiographic results and stem survivorship were compared between the matched two groups.

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Results:

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A total of 611 femurs (56%) were classified as type A, 427 (39%) as type B, and 51 (5%) as type C. More

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radiolucent lines around femoral stems were found in type A femurs (7.8%) than in type B femurs (2.5%)

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(P<0.001). Patients with radiolucency showed worse Harris hip score (86.2 points) compared to those

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without radiolucency (93.0 points) (P<0.001). The stem survivorship of type A femur (97.8%) was lower

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than that of type B femur (99.5%) (P=0.041). The reasons for femoral revision in type A femurs were

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periprosthetic fracture (67%), aseptic loosening (22%), and deep infection (11%).

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Conclusions: This study showed a higher rate of complications following THAs using a cementless tapered wedge stem in Dorr type A femurs than those performed in type B femurs.

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Keywords: Dorr classification, tapered wedge stem, periprosthetic femoral fracture, stem survivorship, total

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hip arthroplasty

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Abbreviations

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THA, total hip arthroplasty; PFF, periprosthetic femoral fracture; BMI, body mass index; HHS, Harris hip

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score; UCLA, University of California at Los Angeles; ONFH, osteonecrosis of the femoral head; BMD,

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bone mineral density

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Introduction The use of cementless tapered wedge stems with a broaching procedure is common in contemporary total

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hip arthroplasty (THA). Because of a recent trend in sparing the maximum bone stock and achieving

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proximal fixation, tapered wedge stems are gaining more popularity[1-4]. However, with this type of stem,

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the shape of the individual proximal femur is more important than with the traditional fit-and-fill stem.

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Tapered wedge stems require tight initial fixation at the proximal metaphysis mediolaterally and three-point

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fixation anteroposteriorly without the help of reaming[1,4].

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Anatomic variations in proximal femurs exist. The geometry of the proximal femur was previously

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classified into 3 types by Dorr et al.[5]. Although various shapes of femoral implants have been introduced,

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most were developed based on the femurs with an average canal dimension close to that of type B femurs. As

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a result, each implant does not perfectly match all types of femur. For type A femurs, which have thick

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cortices with champagne flute canals, this dimensional mismatch can be more severe. There is a high chance

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of tight distal fixation with insufficient metaphyseal contact with this type of femur[6,7].

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There are also concerns of increased risks of periprosthetic femoral fracture (PFF) in THA with cementless

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implants[8-11]. Recently, in a systemic review, Carli et al.[12] reported a three-fold increase in rates of PFF

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with cementless tapered wedge stems. Although type A femurs have been considered safe in terms of

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PFFs[13], recent studies have reported a high incidence of PFF in femurs with narrow canals as well[14,15].

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Despite its significance, there is a lack of understanding regarding the relationship between the femoral

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geometry and outcomes of the femoral implant. We questioned whether a cementless tapered wedge stem for

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THA would be as safe to use in Dorr type A femurs as in ordinary type B femurs. In this study, we compared

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the clinical and radiographic outcomes of THA using a tapered wedge stem between Dorr types A and

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B femurs after a minimum follow-up of 5 years.

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Materials and Methods

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Patient cohort

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This study was conducted under the approval of our institutional ethics committee review board. Between

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January 2007 and December 2012, a total of 2108 consecutive THAs (1682 patients) were performed by a

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single senior surgeon in our institution. We identified 1013 patients (1264 hips) who underwent primary

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cementless THA utilizing an identical double tapered wedge stem. Femurs with any radiographic evidence of

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proximal deformity below the level of anatomical neck were excluded, and patients with hereditary disease

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affecting the skeletal system were also excluded from the study.

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Of 1013 patients, 27 patients (32 hips) died for reasons unrelated to the surgery, and 76 (107 hips) were

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lost to follow-up before reaching a minimum of 5 years. Thirty-four patients (36 hips) were excluded

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because of femoral deformities caused by infection, tumor, trauma, genetic disorder and previous surgeries.

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Full clinical and radiographic data were available for 876 patients (1089 hips) who were enrolled in this

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study.

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Surgical characteristics All surgeries were performed through the anterolateral approach by a single experienced surgeon.

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Preoperative templating was conducted in all cases using standard radiographs with magnification markers.

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Femoral preparations were performed by only the broaching technique.

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The same prosthesis was used in all surgeries. The femoral implant was a cementless Bencox stem

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(Corentec, Cheon-An, South Korea) made of titanium alloy (Fig. 1). The geometry of this stem is similar to

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the CLS Spotorno stem (Zimmer, Warsaw, IN, USA), which has a double tapered wedge design with a

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rectangular cross-section and a slim diaphyseal part. The stem has a neck-shaft angle of 135° and a taper of

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12-14 mm in diameter with a circular cross-section. Various stem sizes are available, ranging from 1 to 13.

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The surface was treated by grit-blasting and the micro-arc oxidation method. This stem can be classified as

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type 3C according to the classification suggested by Mont et al.[1]. The acetabular component was a

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cementless Bencox cup (Corentec), which is made of titanium alloy and coated using the plasma spray

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method. The operator used a ceramic-on-ceramic bearing in all cases.

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Clinical assessments

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The Harris hip scores (HHSs) and University of California at Los Angeles (UCLA) activity scores were

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recorded preoperatively. Clinical outcome was evaluated at each outpatient visit scheduled at 2, 6, and 12

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months postoperatively and then annually. If patients experienced any postoperative pain, the location of

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pain (e.g., the thigh, trochanteric area, groin, and buttocks) was recorded in their medical record. We

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identified major postoperative complications such as PFF, dislocation, aseptic loosening, infection, nerve

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palsy, and any reoperations retrospectively.

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Radiographic measurements

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All radiographs were measured twice each by 2 independent orthopedic surgeons who were fellows of hip

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arthroplasty and had not participated in the surgery. The measurement was performed after removing all

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identifying information of the patients. For continuous variables (e.g., the canal width), the average values

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were used. For categorical variables, the value of the majority was used. The investigators used a picture

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archiving and communication system (Centricity Enterprise Web V3.0, GE Medical Systems, Barrington, IL).

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The radiographs obtained at the last follow-up were used for postoperative radiographic comparison. We

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identified radiolucency of >1 mm around the femoral stem by using the Gruen zones[16] of the femur. Gruen

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zones 1, 7, 8, and 14 were considered as proximal zones, and zones 3, 4, 5, 10, 11, and 12 as distal zones.

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The alignment of the femoral component was classified as varus (>3°), valgus (>3°), or neutral. Subsidence

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of the femoral component >4 mm was considered clinically meaningful. The mode of fixation of the stem

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was categorized as bone ingrown, fibrous stable, or unstable using Engh et al.’s classification[17], and PFFs

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were categorized based on the Vancouver classification[18].

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Determination of bone types

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Femoral geometries were categorized according to the classification system of Dorr et al.[5] by using

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standard preoperative anteroposterior radiographs. The calcar width was measured at the middle level of the

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lesser trochanter, and the canal width was measured at 10 cm below the lesser trochanter (Fig. 2). The

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calcar-to-canal ratio was used to determine the bone types[19,20]. Femurs with a ratio of 0-0.500 were

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considered as type A, 0.501-0.750 as type B, and 0.751-1 as type C (Fig. 3). The intraclass correlation

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coefficient (ICC) was used to evaluate the reliability of the canal width ratio. The ICC for intraobserver

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agreement was 91.4% (95% confidence interval [CI], 88.5%-94.3%), and ICC for interobserver agreement

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was 88.7% (95% CI, 85.2%-92.2%).

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Statistical analysis

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To reduce possible confounding factors, groups with types A and B femurs were statistically matched by

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age, sex, body mass index (BMI), follow-up period, and diagnosis. One-way analysis of variance was used to

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compare continuous variables, and the chi-square or Fisher’s exact test was used to compare categorical

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variables among 3 groups. Groups with types A and B femurs were matched using propensity score matching,

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as generated by logistic regression analysis. The paired t-test was used to analyze improvements in clinical

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scores for each group. To compare 2 groups, the Student’s t-test and Wilcoxon rank sum test were used for

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continuous variables. Survivorship analysis was performed with the Kaplan-Meier estimator using the end

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point of stem revision for any reason. Statistical analysis was performed using SPSS statistics software,

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version 24.0 (IBM Corp., Armonk, NY, USA), and P<0.05 was considered statistically significant.

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Results

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Patient characteristics There were 418 men (519 hips, 47.7%) and 458 women (570 hips, 52.3%) with a mean age of 52.5 years

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(range, 16-81 year) at the index operation. The mean BMI was 24.4 kg/m2 (range, 15.3-37.9 kg/m2). Primary

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diagnoses for THA included osteonecrosis of the femoral head (ONFH) (520 hips, 47.8%), osteoarthritis

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(469 hips, 43.1%), and inflammatory arthritis, fracture, and others (100 hips, 9.2%). The mean follow-up

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period was 84 months (range, 60-133 months).

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Characteristics of bone types

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Among 1089 hips, 611 femurs (56.0%) were classified as type A, 427 (39.3%) as type B, and 51 (4.7%) as

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type C. There were significant differences in age, sex, and diagnosis between the 3 groups (Table I). Patients

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with type A femurs were the youngest (mean, 50.6 years), and those with type C femurs were the oldest

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(mean, 64.7 years). There was a slight male predominance (54.7 %) in the type B femur group, whereas the

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other groups showed female predominance. The most common diagnosis for patients with type C femurs was

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osteoarthritis, whereas that for patients with the other 2 types was ONFH. There were also differences

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between the 3 groups in implant size selection. After one-to-one propensity score matching was performed

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for type A and B femurs, no meaningful difference was found in all patient characteristics (Table II). All

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clinical and radiographic results, complications, and revision rates were compared between the matched 2

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groups.

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Clinical outcomes

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In both groups, clinical scores improved significantly after THA (Table III). For type A femurs, the mean

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HHS increased from 45.1 points preoperatively to 92.3 points postoperatively. The mean UCLA score

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improved from 3.16 points to 6.44 points. After THA, type B femurs also showed improvement in HHSs

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(from 44.0 to 92.9) and UCLA scores (from 3.10 to 6.46). Patients with type A femurs experienced more

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thigh pain than those with type B femurs (P=0.008). No significant differences were found regarding

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postoperative HHSs and UCLA scores at the final follow-up.

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Radiographic features

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More femoral radiolucent lines were found in type A femurs than in type B femurs (7.8% versus [vs.]

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2.5%) (P<0.001) (Table IV). Those were mostly limited to proximal zones (93.8%) (Fig. 4A-D). Stems in

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type A femurs showed more neutral alignments than those in type B femurs (95.6% vs. 89.5%) (P<0.001).

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More radiographic osteointegration was found in type B femurs than in type A femurs (94.9% vs. 90.7%)

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(P=0.026). The patients with radiolucency felt more thigh pain (31%) and groin pain (16.7%) than those

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without radiolucency (Table V), and the postoperative HHS was significantly lower in these patients

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(P<0.001).

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Complications and revisions

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There were more PFFs in patients with type A femurs than in those with type B femurs (3.2% vs. 1.0%)

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(P=0.027) (Table VI). Of them, 4 fractures were caused intraoperatively, whereas no intraoperative fracture

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occurred in patients with type B femurs. There were 9 postoperative Vancouver B2 fractures, all of which

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were revised using a distal fixating prosthesis (Fig. 5A-C). Two patients with type A femurs showed

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radiolucency with persistent thigh pain and underwent revision with a different type of stem. One patient

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developed periprosthetic infection and required 2-stage revision.

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Type A femurs (9 hips, 2.2%) showed a higher femoral revision rate than type B femurs (2 hips, 0.5%)

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(P=0.034). In type A femurs, reasons for stem revision were PFF (6 hips, 66.7%), aseptic loosening (2 hips,

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22.2%), and infection (1 hip, 11.1%). All type B femurs were revised because of the occurrence of PFFs.

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Stem survivorship

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Kaplan-Meier curves for stem survivorship with the end point of revision for any reason are shown in

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Figures 6 and 7. Matched type A femurs (97.8%) showed a lower stem survival rate than matched type B

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femurs (99.5%) at a mean follow-up of 7 years (log rank, P=0.041). Including unmatched cases, the overall

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stem survival rate was 98.5% (type A femurs, 98.0%; type B femurs, 99.5%; and type C femurs, 96.1%).

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Discussion

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The prevalence of type A femurs was higher than we expected. Patients’ age seemed to have a substantial

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impact on the femoral morphology. Nash et al.[21] reported a prevalence rate for type A femurs of 16.9%

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after analyzing patients with a mean age of 85 years. However, Issa et al.[19] reported a similar prevalence

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(63.0%) to ours in a study of younger patients (mean age, 53.5 years). Kim et al.[22] reported even higher

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incidence of type A femurs (85%) after investigating 871 patients with a mean age of 52.9 years. We also

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found a tendency of age progression in patients from type A femurs to types B and C femurs. This result is

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supported by previous studies about age-related changes in the geometry of the femur based on CT

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findings[23,24]. Another explanation for this result is that we studied on Asian patients. Several studies have

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reported a smaller canal diameter in femurs of Asian women[25,26].

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PFFs following THA are devastating complications associated with cementless tapered wedge stems.

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There have been conflicting reports regarding the risk of periprosthetic fractures in femurs with thick cortices

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and narrow canals[12-15,18]. This discrepancy might have resulted from differences in the patient

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characteristics. PFFs frequently occur in women of advanced age with compromised bone quality. Patients

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with type A femurs were usually younger and had a higher bone mineral density (BMD)[4]. Without

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considering the bias caused by patient factors, the result would be affected by the bone quality rather than the

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geometry of the femur. We were unable to obtain data on preoperative BMD; thus, we focused more on the

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pure dimensional difference of the femur by matching age, sex, BMI, and diagnosis.

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From the geometric viewpoint, type A femurs would not be a favorable bone type for the broaching

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procedure. A sharp narrowing of the proximal canal carries a higher risk of intraoperative fracture during

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impaction of the implant. To obtain an interface that fits in the proximal femur, the operator would have to

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give a higher stress to the narrow canal. In this situation, a rectangular cross-sectional shape of the implant

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can cause a sudden increase in hoop tension on the cortex due to the wedge effect[14], which may eventually

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lead to a fracture. If the implant is oversized or malpositioned, the stress can be even greater. Postoperatively,

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a tight diaphyseal fixation[6,7] may contribute to an increased hoop stress when the sudden rotational or

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axial force is delivered before sufficient osteointegration is made. There is also a possibility of overlooking

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intraoperative damage on the cortex that progresses to an obvious fracture line caused by minor stresses. In

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this study, most type A fractures were caused by low energy trauma, and they frequently occurred before 3

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months postoperatively. However, more biomechanical evidence is needed to support this hypothesis.

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In the present study, more radiolucent lines were found in type A femurs than in type B femurs. These

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lines were typically found in the proximal zones (Gruen zones 1, 7, 8, and 14) as shown in figures 4C and D.

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This can serve as evidence for the mismatch between the metaphysis and diaphysis of the femur[6,7,27,28].

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During stem insertion, tight distal fixation can prevent ideal compaction of cancellous bone in the

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metaphyseal region. Additionally, this phenomenon is partially due to undersizing of the implant[29].

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Operators tend to choose smaller stems to prevent causing intraoperative fracture of narrow femoral

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canals[14]. Wangen et al.[28] reported 22 cases (18%) of radiolucent lines in 93 tapered wedge stems.

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However, they could not find a correlation with the hip score, pain, function, and loosening rate. Probably

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because of a larger volume, we found inferior clinical scores and more thigh pain in patients with radiolucent

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lines than in those without radiolucent lines. We performed 2 femoral revisions in patients with a

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combination of radiolucency and progressive thigh pain. Micromotion in the proximal region can be

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generated by bending moment when the axial loading is delivered[6]. This can cause thigh pain, especially

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when a higher weight is applied. Herein, we found several patients with proximal radiolucency complaining

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of thigh pain only when they were lifting a heavy object. Some other patients experienced varying degrees of

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pain caused during the few initial steps when they were walking. Longer follow-ups will be necessary to

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clarify whether the symptoms in these patients will eventually require additional revisions.

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The current study has several important take-away messages. A type A femur is not a rare type of femur

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among young individuals, and it may not be a favorable candidate for tapered wedge stems. There are

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possibilities of unexpected early failures and unpleasant clinical outcomes. For this type of femur, we

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recommend that surgeons pay more attention when choosing, templating, sizing, and implanting tapered

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wedge stems. Experience with various femoral implants would help determine the best suitable implant. A

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distal reaming technique can also be helpful to reduce the proximal/distal discrepancy and ensure optimal

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metaphyseal filling of the implant. Although not included in this series, we performed distal reaming on a

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few recent cases with narrow femoral canal, especially when a tight distal fixation was perceived before

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reaching the desired size of the broach. However, a caution should be made not to ream out the host bone

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excessively and disturb natural contact area of tapered wedge stems.

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To the best of our knowledge, this study is the first matched comparative study about the relationship

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between the femoral bone type and stem survivorship. The strengths of this study include the large volume,

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completeness of clinical and radiographic data, reduction of confounding factors, and homogeneity of the

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implant choice.

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There are also some limitations to the present study. First, this was a retrospective study. However, a

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prospective randomization would be not feasible because of the inherent nature of the femoral geometry.

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Second, the femoral geometry was classified using only the Dorr classification. Although this classification

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is simple and widely accepted, it is based on plain radiographs, which can be inaccurate, and it does not

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reflect multiple aspects of femoral geometry. Future studies using more precise modalities, such as CT, will

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be needed. Third, a large number of young patients with osteonecrosis were included. These patient

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characteristics might have affected the overall outcome of our study. Fourth, the mean follow-up period of 7

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years was relatively short, particularly for a cohort of young patients. Follow-up studies with a longer

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observation period will be necessary for a long-term comparison. Lastly, this was a single-center study, in

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which all operations were performed by a single senior surgeon using the same type of implant. There may

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be a surgeon factor as well as an implant factor that affected the current study’s result.

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In conclusion, this study showed a lower stem survivorship and higher complication rates following THAs

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using a cementless tapered wedge stem in Dorr type A femurs than those performed in type B femurs. The

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most common reason for stem revision in type A femurs was the periprosthetic femoral fracture.

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Conflict of interest: None.

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References

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1.

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arthroplasty. J Bone Joint Surg Am 2011;93:500. 2.

253 254

McLaughlin JR, Lee KR. Uncemented total hip arthroplasty using a tapered femoral component in obese patients: an 18-27 year follow-up study. J Arthroplasty 2014;29:1365.

3.

RI PT

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Khanuja HS, Vakil JJ, Goddard MS, et al. Cementless femoral fixation in total hip

Grant TW, Lovro LR, Licini DJ, et al. Cementless Tapered Wedge Femoral Stems Decrease

255

Subsidence in Obese Patients Compared to Traditional Fit-and-Fill Stems. J Arthroplasty

256

2017;32:891.

257

4.

Oba M, Inaba Y, Kobayashi N, et al. Effect of femoral canal shape on mechanical stress distribution and adaptive bone remodelling around a cementless tapered-wedge stem. Bone

259

Joint Res 2016;5:362. 5.

261 262

Dorr LD, Faugere MC, Mackel AM, et al. Structural and cellular assessment of bone quality of proximal femur. Bone 1993;14:231.

6.

M AN U

260

SC

258

Ishii S, Homma Y, Baba T, et al. Does the Canal Fill Ratio and Femoral Morphology of Asian

263

Females Influence Early Radiographic Outcomes of Total Hip Arthroplasty With an

264

Uncemented Proximally Coated, Tapered-Wedge Stem? J Arthroplasty 2016;31:1524. 7.

266 267

Cooper HJ, Jacob AP, Rodriguez JA. Distal fixation of proximally coated tapered stems may predispose to a failure of osteointegration. J Arthroplasty 2011;26:78.

8.

Colacchio ND, Robbins CE, Aghazadeh MS, et al. Total Hip Intraoperative Femur Fracture:

TE D

265

268

Do the Design Enhancements of a Second-Generation Tapered-Wedge Stem Reduce the

269

Incidence? J Arthroplasty 2017;32:3163.

270

9.

Lim SJ, Lee KJ, Min BW, et al. High incidence of stem loosening in association with periprosthetic femur fractures in previously well-fixed cementless grit-blasted tapered-

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wedge stems. Int Orthop 2015;39:1689.

273

10.

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Song JSA, Dillman D, Wilson D, et al. Higher periprosthetic fracture rate associated with use of modern uncemented stems compared to cemented stems in femoral neck fractures. Hip

275

Int 2018:1120700018772291.

276

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Zhang Z, Zhuo Q, Chai W, et al. Clinical characteristics and risk factors of periprosthetic

277

femoral fractures associated with hip arthroplasty: A retrospective study. Medicine

278

(Baltimore) 2016;95:e4751.

279

12.

Carli AV, Negus JJ, Haddad FS. Periprosthetic femoral fractures and trying to avoid them:

280

what is the contribution of femoral component design to the increased risk of periprosthetic

281

femoral fracture? Bone Joint J 2017;99-b:50.

282

13.

Gromov K, Bersang A, Nielsen CS, et al. Risk factors for post-operative periprosthetic

283

fractures following primary total hip arthroplasty with a proximally coated double-tapered

284

cementless femoral component. Bone Joint J 2017;99-b:451.

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14.

Bonnin MP, Neto CC, Aitsiselmi T, et al. Increased incidence of femoral fractures in small

286

femurs and women undergoing uncemented total hip arthroplasty - why? Bone Joint J

287

2015;97-b:741. 15.

290

intraoperative fracture of the femoral bone. Ortop Traumatol Rehabil 2010;12:237. 16.

291 292

components: a radiographic analysis of loosening. Clin Orthop Relat Res 1979:17. 17.

293 294

Engh CA, Bobyn JD, Glassman AH. Porous-coated hip replacement. The factors governing bone ingrowth, stress shielding, and clinical results. J Bone Joint Surg Br 1987;69:45.

18.

295 296

Gruen TA, McNeice GM, Amstutz HC. "Modes of failure" of cemented stem-type femoral

RI PT

289

Dorman T, Sibinski M, Kmiec K, et al. Cementless hip joint alloplasty complicated by

Duncan CP, Masri BA. Fractures of the femur after hip replacement. Instr Course Lect 1995;44:293.

19.

SC

288

Issa K, Stroh AD, Mont MA, et al. Effect of bone type on clinical and radiographic outcomes of a proximally-coated cementless stem in primary total hip arthroplasties. J Orthop Res

298

2014;32:1214.

299

20.

M AN U

297

Dossick PH, Dorr LD, Gruen T, et al. Techniques for preoperative planning and

300

postoperative evaluation of noncemented hip arthroplasty. Techniques in Orthopaedics

301

1991;6:1.

302

21.

Nash W, Harris A. The Dorr type and cortical thickness index of the proximal femur for predicting peri-operative complications during hemiarthroplasty. J Orthop Surg (Hong Kong)

304

2014;22:92.

305

22.

306 307

TE D

303

Kim YH, Park JW, Kim JS. Long-Term Results of Third-Generation Ceramic-on-Ceramic Bearing Cementless Total Hip Arthroplasty in Young Patients. J Arthroplasty 2016;31:2520.

23.

Ito M, Nakata T, Nishida A, et al. Age-related changes in bone density, geometry and biomechanical properties of the proximal femur: CT-based 3D hip structure analysis in

309

normal postmenopausal women. Bone 2011;48:627.

310

24.

EP

308

Yuen KW, Kwok TC, Qin L, et al. Characteristics of age-related changes in bone compared between male and female reference Chinese populations in Hong Kong: a pQCT study. J

312

Bone Miner Metab 2010;28:672.

313

25.

314 315

26.

27.

Lass R, Kolb A, Skrbensky G, et al. A cementless hip system with a new surface for osseous integration. Int Orthop 2014;38:703.

28.

320 321

Umer M, Sepah YJ, Khan A, et al. Morphology of the proximal femur in a Pakistani population. J Orthop Surg (Hong Kong) 2010;18:279.

318 319

Cho HJ, Kwak DS, Kim IB. Morphometric Evaluation of Korean Femurs by Geometric Computation: Comparisons of the Sex and the Population. Biomed Res Int 2015;2015:730538.

316 317

AC C

311

Wangen H, Nordsletten L, Boldt JG, et al. The Corail stem as a reverse hybrid survivorship and x-ray analysis at 10 years. Hip Int 2017;27:354.

29.

Dundon JM, Felberbaum DL, Long WJ. Femoral stem size mismatch in women undergoing

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total hip arthroplasty. J Orthop 2018;15:293.

323 324 325 326

RI PT

327 328 329 330 331

SC

332 333 334

M AN U

335 336 337 338 339 340

344 345 346 347 348 349 350 351 352

EP

343

AC C

342

TE D

341

353 354 355 356 357 358

19

ACCEPTED MANUSCRIPT Legends to figures

360

Fig. 1. A double tapered wedge stem with a grit-blasted surface treatment. (Bencox; Corentec, Cheon-An,

361

South Korea)

362

Fig. 2. Radiographic features of different bone types by the Dorr classification (type A, B and C)

363

Fig. 3. Determination of bone types using femoral canal width (FW) and calcar width (CW). The value of

364

calcar-to-canal ratio (FW/CW) was used for the classification.

365

Figs. 4. Postoperative radiographs of a 49-year old female with type A femur who had undergone THA due

366

to secondary osteoarthritis. Figs. 4-A and 4-B Two-month postoperative images show minimal proximal

367

radiolucent lines. Figs. 4-C and 4-D More obvious proximal radiolucent lines were found with hypertrophic

368

distal cortices 65 months after the index operation.

369

Figs. 5. A 65-year old man with type A femur underwent THA owing to secondary osteoarthritis. Fig. 5-A

370

Immediate postoperative radiograph demonstrates stable stem fixation. Fig. 5-B Femoral radiograph shows

371

periprosthetic fracture (Vancouver B2) resulted from a minor trauma 1 month after the surgery. Fig. 5-C

372

Isolated stem revision was performed using a distal fixating modular stem.

373

Fig. 6. Stem survival curves for matched type A and B femurs (log rank, P=0.041).

374

Fig. 7. Stem survival curves for type A, B and C femurs (log rank, P=0.047).

AC C

EP

TE D

M AN U

SC

RI PT

359

20

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2

Fig. 1. A double tapered wedge stem with a grit-blasted surface treatment. (Bencox; Corentec, Cheon-An,

3

South Korea)

4

Fig. 2. Radiographic features of different bone types by the Dorr classification (type A, B and C)

5

Fig. 3. Determination of bone types using femoral canal width (FW) and calcar width (CW). The value of

6

calcar-to-canal ratio (FW/CW) was used for the classification.

7

Figs. 4. Postoperative radiographs of a 49-year old female with type A femur who had undergone THA due

8

to secondary osteoarthritis. Figs. 4-A and 4-B Two-month postoperative images show minimal proximal

9

radiolucent lines. Figs. 4-C and 4-D More obvious proximal radiolucent lines were found with hypertrophic

M AN U

SC

RI PT

1

distal cortices 65 months after the index operation.

11

Figs. 5. A 65-year old man with type A femur underwent THA owing to secondary osteoarthritis. Fig. 5-A

12

Immediate postoperative radiograph demonstrates stable stem fixation. Fig. 5-B Femoral radiograph shows

13

periprosthetic fracture (Vancouver B2) resulted from a minor trauma 1 month after the surgery. Fig. 5-C

14

Isolated stem revision was performed using a distal fixating modular stem.

15

Fig. 6. Stem survival curves for matched type A and B femurs (log rank, P=0.041).

16

Fig. 7. Stem survival curves for type A, B and C femurs (log rank, P=0.047).

AC C

EP

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10

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ACCEPTED MANUSCRIPT Table I. Baseline characteristics of three groups Type A (N = 611)

Type B (N = 427)

Type C (N = 51)

495

340

41

50.6 ± 13.6

54.0 ± 13.8

64.7 ± 12.0

0.001

RI PT

1

0.001

Number of patients Patient age* (yr) Gender† Male

266 (43.6%)

234 (54.7%)

Female

345 (56.4%)

193 (45.3%)

289 (47.4%)

Osteoarthritis

282 (46.1%)

Fracture & Others

40 (6.6%)

Ethnicity† 608 (99.5%)

Others BMI* (kg/m²)

Stem size* (number)

<0.001

16 (31.4%)

162 (38.1%)

25 (49.0%)

50 (11.7%)

10 (19.6%) 0.709 51 (100%)

3 (0.5%)

1 (0.2%)

0 (0%)

24.4 ± 3.4

24.3 ± 3.3

24.1 ± 3.1

0.901

83.8 ± 23.7

85.1 ± 25.1

75.7 ± 21.8

0.520

4.4 ± 1.7

5.6 ± 1.7

6.4 ± 2.0

0.002

EP

Follow-up duration* (mo)

32 (62.7%)

426 (99.8%)

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Asian

215 (50.2%)

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ONFH‡

19 (37.3%)

SC

Diagnosis†

P Value

*The values are given as the mean and the standard deviation. †The values are given as the number of hips

3

with the percentage in parentheses. ‡ ONFH = Osteonecrosis of femoral head.

4 5

AC C

2

6 7 8 9

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Type B (N = 408)

328

328

53.3 ± 13.7

53.6 ± 13.4

Number of patients Patient age* (yr)

P Value

0.947

RI PT

1

Gender†

1.000

219 (53.7%)

219 (53.7%)

Female

189 (46.3%)

189 (46.3%)

SC

Male

Diagnosis†

0.091

197 (48.3%)

Osteoarthritis

181 (44.4%)

156 (38.2%)

30 (7.4%)

44 (10.8%)

BMI* (kg/m²)

24.3 ± 3.4

24.4 ± 3.3

0.555

Follow-up duration* (mo)

87.8 ± 18.5

85.2 ± 20.5

0.058

5.6 ± 1.8

<0.001

TE D

Fracture & Others

Stem size* (number)

208 (51.0%)

M AN U

ONFH

4.5 ± 1.7

*The values are given as the mean and the standard deviation. †The values are given as the number of hips

3

with the percentage in parentheses. ‡ ONFH = Osteonecrosis of femoral head.

5 6 7 8

AC C

4

EP

2

9 10 11

1

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Table III. Clinical outcomes of matched two groups Type A (n=408)

Type B (n=408)

P Value

Preoperative

45.3 ± 13.1

44.0 ± 14.6

0.176

Postoperative

92.3 ± 9.17

92.9 ± 7.36

0.242

Preoperative

3.11 ± 0.97

3.00 ± 0.95

0.947

Postoperative

6.44 ± 1.28 19 (4.7%)

Postoperative groin pain†

20 (4.9%)

6.46 ± 1.13

0.772

6 (1.5%)

0.008

M AN U

Postoperative thigh pain†

SC

UCLA activity score*

RI PT

Harris hip score*

12 (2.9%)

0.149

2

*The values are given as the mean and the standard deviation. †The values are given as the number of hips

3

with the percentage in parentheses.

7 8 9 10 11 12

EP

6

AC C

5

TE D

4

13 14 15 16

1

ACCEPTED MANUSCRIPT Table IV. Radiographic features of matched two groups Type B (n=408)

P Value

32 (7.8%)

10 (2.5%)

<0.001

30 (7.4%)

7 (1.7%)

0 (0%)

2 (0.5%)

2 (0.5%)

1 (0.2%)

Radiolucent lines Proximal zones only Distal zones only Proximal & distal zones Stem position

<0.001

Neutral

390 (95.6%)

365 (89.5%)

Varus

16 (3.9%)

43 (10.5%)

Valgus

2 (0.5%) 16 (3.9%)

Stem stability

5 6 7 8

0.571 0.026

387 (94.9%)

Fibrous stable

36 (8.8%)

21 (5.1%)

Unstable

2 (0.5%)

0 (0%)

Subsidence

7 (1.7%)

1 (0.2%)

0.069

Heterotrophic ossification

33 (8.1%)

46 (11.3%)

0.124

TE D

370 (90.7%)

The values are given as the number of hips with the percentage in parentheses.

EP

4

13 (3.2%)

Bone ingrowth

AC C

3

0 (0%)

M AN U

Cortical hypertrophy

2

RI PT

Type A (n=408)

SC

1

9 10 11 12

1

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Table V. Clinical outcomes of femurs with and without radiolucency With radiolucency (n=42)

Without radiolucency (n=774)

P Value

Preoperative

42.5 ± 12.7

44.8 ± 13.9

0.299

Postoperative

86.2 ± 15.7

RI PT

Harris hip score*

Preoperative

3.14 ± 0.95

Postoperative

6.00 ± 1.61 13 (31%)

Postoperative groin pain†

7 (16.7%)

3.05 ± 0.96

0.549

6.47 ± 1.18

0.067

12 (1.6%)

<0.001

25 (3.2%)

0.001

M AN U

Postoperative thigh pain†

<0.001

SC

UCLA activity score*

93.0 ± 7.6

2

*The values are given as the mean and the standard deviation. †The values are given as the number of hips

3

with the percentage in parentheses.

7 8 9 10 11 12

EP

6

AC C

5

TE D

4

13 14 15 16

1

ACCEPTED MANUSCRIPT Table VI. Major complications and revision rates of matched two groups Type B (n=408)

P Value

13 (3.2%)

4 (1.0%)

0.027

4 (1.0%)

0 (0%)

0.124

4 (1.0%)

0 (0%)

9 (2.2%)

4 (1.0%)

Vancouver AG

1 (0.2%)

1 (0.2%)

Vancouver B1

1 (0.2%)

Vancouver B2

7 (1.7%)

Periprosthetic femoral fracture Intraoperative Vancouver A2

2 (0.5%)

0 (0%)

0.499

Aseptic cup loosening

2 (0.5%)

1 (0.2%)

1.000

Deep infection

3 (0.7%)

1 (0.2%)

0.624

0 (0%)

0 (0%)

1.000

3 (0.7%)

1 (0.2%)

0.624

9 (2.2%)

2 (0.5%)

0.034

3 (0.7%)

1 (0.2%)

0.624

0 (0%)

1.000

TE D

Dislocation Stem revision

EP

Cup revision Revision of both components

4 5

1 (0.2%)

The values are given as the number of hips with the percentage in parentheses.

AC C

3

2 (0.5%)

Aseptic stem loosening

Nerve palsy

2

0.162

1 (0.2%)

M AN U

Postoperative

RI PT

Type A (n=408)

SC

1

6 7 8

1

AC C

EP

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