Fibular Collateral Ligament Reconstruction Graft Options: Clinical and Radiographic Outcomes of Autograft Versus Allograft

Journal Pre-proof Isolated Fibular Collateral Ligament Reconstruction Graft Options in the setting of ACL reconstruction: Clinical and Radiographic Outcomes of Autograft versus Allograft Travis J. Dekker, MD, William Schairer, MD, W. Jeffrey Grantham, MD, Nicholas N. DePhillipo, MS, ATC, OTC, Zachary S. Aman, BA, Robert F. LaPrade, MD, PhD PII:

S0749-8063(20)30890-2

DOI:

https://doi.org/10.1016/j.arthro.2020.10.034

Reference:

YJARS 57201

To appear in:

Arthroscopy: The Journal of Arthroscopic and Related Surgery

Received Date: 15 February 2020 Revised Date:

13 October 2020

Accepted Date: 17 October 2020

Please cite this article as: Dekker TJ, Schairer W, Grantham WJ, DePhillipo NN, Aman ZS, LaPrade RF, Isolated Fibular Collateral Ligament Reconstruction Graft Options in the setting of ACL reconstruction: Clinical and Radiographic Outcomes of Autograft versus Allograft, Arthroscopy: The Journal of Arthroscopic and Related Surgery (2020), doi: https://doi.org/10.1016/j.arthro.2020.10.034. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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. © 2020 Published by Elsevier on behalf of the Arthroscopy Association of North America

Fibular Collateral Ligament Reconstruction Graft Options: Clinical and Radiographic Outcomes of Autograft versus Allograft

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Travis J. Dekker, MD1 William Schairer, MD1 W. Jeffrey Grantham, MD1 Nicholas N. DePhillipo, MS, ATC, OTC3 Zachary S. Aman, BA2 Robert F. LaPrade, MD, PhD3

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The Steadman Clinic Steadman Philippon Research Institute 3 Twin Cities Orthopaedics

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Corresponding Author Robert F. LaPrade MD, PhD Twin Cities Orthopaedics Edina, Minnesota [email protected]

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Isolated Fibular Collateral Ligament Reconstruction Graft Options in the setting of ACL reconstruction: Clinical and Radiographic Outcomes of Autograft versus Allograft

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Abstract

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Purpose: To compare varus knee stability and clinical outcomes between patients who

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underwent fibular collateral ligament reconstruction (FCLR) with autografts versus allografts when undergoing concomitant anterior cruciate ligament reconstruction (ACLR).

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Methods: All patients who underwent primary ACLR and concomitant FCLR from 2010 to

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2017 by a single surgeon (R.F.L.) were retrospectively identified. Clinical characteristics and

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graft choice for FCLR was collected. Patients with a minimum 2-year follow-up for clinical

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outcome scores and 6-month stress radiographs were included. Patients with any other

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ligamentous procedure or revision ACLR were excluded

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Results: There were 69 primary ACLR with concomitant FCLR patients identified that met the

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inclusion criteria. Fifty patients underwent FCLR with semitendinosus autograft compared to 19

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patients with allografts. There were no significant side-to-side difference (SSD) in lateral

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compartment gapping on varus stress x-rays between the two cohorts (allograft= 0.49 mm and

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autograft= 0.15 mm, p= 0.22) with no FCLR failures. There were no significant differences

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when comparing the autograft to allograft group at a minimum 2-year outcomes for SF12 MCS

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(p=0.134) and PCS (p=0.642), WOMAC (total (p=0.158), pain (p=0.116), stiffness (p=0.061),

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activity (p=0.252)), IKDC (p=0.337), Tegner (p=0.601), Lysholm (p=0.622), and patient

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satisfaction (p = 0.218). There were no significant differences in clinical knee stability between

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groups at an average follow-up of 3.6 years (p = 1.0).

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Conclusion: There were no differences in varus stress laxity at 6-months postoperatively or

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clinical outcome scores at minimum 2-year postoperatively between patients with FCL

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reconstructions with either autograft or allograft. This study demonstrates that both hamstring

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autografts and allografts for FCL reconstructions offer reliable and similar radiographic and

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clinical results at short-term follow-up.

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Keywords: graft choice, allograft, autograft, fibular collateral ligament, ligament reconstruction

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Level of Evidence: Level III, retrospective comparative trial.

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Running Title: FCL Reconstruction with Allograft versus Autograft

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Introduction

35 The fibular collateral ligament (FCL) is a primary varus stabilizer of the knee throughout full

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range-of-motion (ROM) and an external rotatory stabilizer with the knee near full extension.1,2

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Isolated FCL injuries are rare, and they most commonly occur with concomitant anterior cruciate

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ligament (ACL), posterior cruciate ligament (PCL) and multi-ligament knee injuries.3–5 In the

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setting of multiligament knee dislocation injuries, FCL injuries occurred in 59% of patients

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which can put additional constraints on ideal and available grafts when considering

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reconstruction.6 When not addressed, FCL pathology can increase the load on concomitant ACL

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or PCL reconstruction grafts, which can ultimately lead to early graft failure and long-term poor

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outcomes.7,8

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Biomechanical and clinical studies have reported complete FCL disruption when there is greater

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than 2.7 mm side-to-side difference (SSD) of lateral compartment gapping on varus stress

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radiographs.9–11 Most recently, Kane et. al. validated a measurement of greater than 2.1 mm as

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being consistent with a complete isolated FCL tear in a large case series.9 Current management

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of incomplete FCL tears (< 2.1 mm) consists of non-operative management and rehabilitation for

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4-6 weeks.12 However, previous authors have theorized that FCL tears have a low likelihood of

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healing nonoperatively due to poor vascularization and the unstable bony geometry of the lateral

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compartment (i.e. convex lateral femur articulating on a convex lateral tibia).13–15 Thus, complete

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FCL disruption, both with and without ACL tears, are recommended to be treated operatively to

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prevent varus instability and long-term detrimental effects of medial compartment

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degeneration.4,16,16,17 In these cases, FCL reconstruction (FCLR) has been suggested to be

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superior to repair techniques with significant improvements in both clinical outcomes and

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biomechanical stability.18–20

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Although routinely used for knee ligament reconstructions, hamstring autograft harvest does

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have associated risks of both short- and long-term complications,21 which most namely include

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sensory deficits to the medial side of the knee due to injuries to the infrapatellar branches of the

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saphenous nerve.21 Furthermore, although greater than 85% of hamstring tendons demonstrate

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regeneration after harvest, there are still concerns about short and long-term strength deficits.22

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While Tashiro et. al. has demonstrated persistent weakness with knee flexion torque strength in

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deep flexion, others have demonstrated no long-term deficits with strength limitations being

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transient. 23–27

68 While different graft options have advantages and disadvantages, a critical evaluation of both

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clinical and radiographic outcomes is necessary to provide practical clinical recommendations on

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their use. Therefore, the purpose of this study is to compare varus knee stability and clinical

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outcomes between patients who underwent fibular collateral ligament reconstruction (FCLR)

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with autografts versus allografts when undergoing concomitant anterior cruciate ligament

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reconstruction (ACLR). The null hypothesis was that there would be no significant difference in

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FCL stability on varus stress radiographs between FCL reconstruction autograft and allograft

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groups at minimum of 6-months follow-up.

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Methods

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An institutional review board (institution blinded for review) approved this study prior to data

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collection. A retrospective review of prospectively collected data was performed from April

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2010 to August 2017 to identify all patients in a single surgeon’s practice (R.F.L.) undergoing

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concomitant FCL and ACL reconstruction. Complete grade III FCL tears identified on varus

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stress radiographs were confirmed on the examination under anesthesia, which served as the gold

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standard for diagnosis. The criterion for FCL reconstruction was varus stress radiographs with a

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side-to-side difference of ≥ 2 mm, consistent with a complete grade III FCL tear.9,28 Bilateral

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varus stress radiographs applied by the senior physician (RFL) with a physician-applied varus

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load at 20º of knee flexion with the use of a foam wedge were performed according to a

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previously validated technique in all suspected patients with FCL tears.10

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Inclusion criteria for this study included combined ACLR and FCLR with a minimum of 2-year

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follow-up and available preoperative and postoperative varus stress radiographs at a minimum of

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6-months postoperatively. Exclusion criteria included patient age greater than 55, revision

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ACLR, revision FCLR, patients with open physes, multi-ligament knee injuries involving the

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posterior cruciate ligament or medial collateral ligament, complete posterolateral corner (PLC)

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reconstructions, incomplete (grade I and grade II) FCL injuries treated nonoperatively, prior

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osteotomy on the ipsilateral knee, or previous injury or surgery to either the FCL or PLC on the

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contralateral knee. Six months was considered a key timepoint to perform postoperative varus

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stress radiographs considering the tendinous grafts would be healed within the bone tunnels by

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this time point.29 FCLR graft choices were recorded including autograft or allograft semitendinosus or tibialis anterior allografts. Clinical evaluation was performed by the attending

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surgeon / senior author, and outcome scores were collected routinely per the institution protocols

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at 6 months, 1-year and 2-years through paper questionnaires. The outcome scores included the

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following: SF-12 mental component score (MCS) and physical component score (PCS), Western

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Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (total, pain, stiffness, and

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activity), International Knee Documentation Committee Subjective Knee Evaluation (IKDC),

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Tegner Activity Scale, Lysholm Score, and patient satisfaction ratings (0-10). Both ACL and

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FCL graft choice was made based on patient preference through thorough discussions and

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counseling of risks and benefits of either graft choice.

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An a priori power analysis was performed according to prior varus radiographic analysis

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studies.10 Assuming a standard deviation of 1.75mm, 14 patients per group provides 80% power

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to detect a difference in 2.0mm in SDD at an alpha level of 0.05. Preoperative and postoperative

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outcome scores and radiographic measures were compared with a two-tailed independent t-test

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with significance set at P < 0.05. Comparisons of categorical data were performed by use of Chi-

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square tests and Fisher Exact tests. Unless otherwise noted, data were reported as mean ±

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standard deviation (SD). All statistical analyses were performed by use of Stata version 14.2

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(Statacorp, College Station, TX).

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Surgical Technique

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All cases began by performing an examination under anesthesia to evaluate the integrity of the

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FCL with varus stress at both 0 and 30 degrees. Furthermore, a dial test under anesthesia aided in

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the confirmation of an isolated FCL injury not involving a complete PLC injury. In addition, the

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popliteus tendon was evaluated arthroscopically in all patients at the time of surgery to confirm

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or deny the presence of a complete PLC injury. All patients underwent concomitant anatomic,

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single-bundle ACLR with either patellar tendon autograft or allograft.30

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A lateral hockey stick incision was made proximally over the iliotibial band and extending

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distally between the fibular head and Gerdy’s tubercle. A common peroneal nerve (CPN)

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neurolysis was performed in all cases. A horizontal incision was then made in the biceps bursa31,

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which, if present, allowed for identification of the FCL remnant. A tag stitch was placed in the

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remnant FCL which could later be tensioned to aid in the identification of the femoral and fibular

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FCL attachment sites. The FCL fibular attachment was identified, and a 6-mm tunnel was then

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reamed from the anterolateral to posteromedial aspect of the fibular head distal to the

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popliteofibular ligament.14 The FCL femoral attachment was then identified via a horizontal

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splitting incision along the fibers of the superficial layer of the iliotibial band over the FCL

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femoral attachment while traction was applied to the tag stitch. Along with the use of palpable

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landmarks (the lateral femoral epicondyle), a 6-mm femoral tunnel was reamed over a guide pin

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in an anterior and proximal trajectory to avoid convergence with a concurrent ACL

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reconstruction tunnel.32 A 7-mm diameter tap was then used to enlarge the tunnel to facilitate

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later interference screw placement, and a passing suture was placed. The autograft or allograft

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tendon was then whipstitched on each end with No. 2 high strength nonabsorbable sutures for the

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FCL reconstruction graft. After any intra-articular work was completed and the ACL

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reconstruction graft was fixed in its femoral tunnel, the FCL graft was fixed in the femoral tunnel

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with a 7x23–mm bioabsorbable interference screw (Smith and Nephew, Memphis, TN), and the

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graft was then passed deep to the iliotibial band and through the fibular head tunnel. The FCL

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graft was then fixed in the fibular head tunnel with a 7x23 mm bioabsorbable screw (Smith and

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Nephew, Memphis, TN) with the knee in 20 of knee flexion, the foot in neutral rotation, and a

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slight valgus reduction force.33 An examination under anesthesia to confirm restoration of varus

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stability was then performed, and any concurrent ACL reconstruction graft was then secured in

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the tibial tunnel.34

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Postoperative Rehabilitation

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All patients initiated postoperative physical therapy the day after surgery and were non-weight

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bearing for 6 weeks in a knee immobilizer brace. Passive ROM exercises began on postoperative

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day one, limiting ROM from 0 to 90 degrees for two weeks and then progressed to full ROM

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thereafter. Weight bearing was initiated at 6 weeks postoperatively and patients transitioned to a

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hinged knee brace and remained in this brace full-time until a minimum of 3 months

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postoperatively. Patients were permitted to begin cycling on a stationary bike at 6 weeks

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postoperatively. Open kinetic chain isolated hamstring exercises were restricted for a minimum

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of 4 months postoperatively to avoid any potential unwanted stress on the FCLR graft. Patients

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completed individualized periodization programs with a focus initially on muscular endurance

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followed by strength and power. Patients were instructed to avoid side-to-side activities and

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pivoting for a minimum of 6 months postoperatively. Full return to desired activities/sports

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occurred between 7 and 9 months after surgery and routine varus stress radiographs confirming

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restoration of lateral compartment stability had been obtained (< 2 mm).

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Patient Demographics

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A total of 69 primary ACLR with concomitant FCLR patients were identified that met the

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inclusion criteria. Of the initially selected 75 patients, 6 were excluded for lack of radiographic

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follow-up. Fifty patients underwent FCLR with a semitendinosus autograft compared to 19

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patients with an allograft (16 semitendinosus and 3 tibialis anterior). At the time of surgery, graft

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choice was made based off of patient preference through thorough discussions and counseling of

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risks and benefits of either graft choice. There was no difference in sex between autograft and

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allograft groups (46.9% vs. 30.0% male, respectively; p = 0.196). Patients in the allograft group

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were significantly older in age (44.6 vs. 31.4 years; p < 0.001). In this cohort, there were no

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surgical complications nor clinical failures and additional data on meniscus status or surgery was

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not available.

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Clinical and Radiographic Outcomes

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All patients had a minimum of 2-year clinical outcomes and a minimum of 6-month radiographic

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outcomes evaluated by fellowship trained sports orthopaedic surgeons (TJD, WWS, RFL). There

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were no significant SSD in lateral compartment gapping on varus stress radiographs between the

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autograft (mean SSD = 0.15 ± 1.08 mm, 95% CI [-0.20 – 0.49]) and allograft (mean SSD = 0.49

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± 0.80 mm, 95% CI [0.10 – 0.89]) groups at minimum of 6 months postoperatively (p = 0.223).

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There were no significant differences in clinical knee stability based on physical exam between

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groups at final follow-up (Grade 0, p=1.000). Additionally, no patients required a revision

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surgery for FCL reconstruction or ACL reconstruction in this cohort of patients.

190 Patient Reported Outcome Measures

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Patient reported preoperative and postoperative scores were measured at a mean 3.6 years

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postoperatively and are presented in Table 1 and Table 2, respectively. There were no differences

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preoperatively or postoperatively between the allograft and autograft groups in SF12 MCS

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(p=0.134) and PCS (p=0.642), WOMAC (Total (p=0.158), pain (p=0.116), stiffness (p=0.061),

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activity (p=0.252)), IKDC (p=0.337), Tegner (p=0.601), and Lysholm (p=0.622) scores.

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Additionally, there was no significant difference in patient satisfaction (p = 0.218). Furthermore,

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each respective cohort was compared to pre- to post-operative outcome scores. The autograft

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cohort demonstrated significant improvement across all domains except IKDC and SF12 MCS

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while the allograft group showed improvement across all domains except the SF12 MCS.

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Additionally, there were no significant differences between groups between the pre- to post-

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operative changes in any patient reported outcome score (p>0.05). Across both treatment groups,

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both MCID (minimal detectable change) and MDC (minimal detectable change) were assessed

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according to Harris et. al. The FCL autograft group demonstrated significant improvements from

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pre- to post-operative states for SF12 PCS, WOMAC activity, WOMAC total, Lysholm and

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Tegner. Similarly, the FCL allograft group improved to MCID or MDC across the SF12 PCS and

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MCS, WOMAC activity, WOMAC total, Lysholm and Tegner activity domains.

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Discussion

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The most important findings of this study found that in patients undergoing concomitant ACL

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and FCL reconstruction, there were no significant differences in knee stability or patient-reported

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outcomes when comparing autografts and allografts for FCL reconstruction. All patients (n=69)

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with minimum 2-year follow-up-maintained FCLR graft integrity, did not require revision FCLR

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surgery, and had no significant SSD on varus stress radiographs at minimum 6-month follow-up.

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Furthermore, patient satisfaction was similar between both groups. These findings provide an

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ability to discuss the risks and benefits of both graft options with the knowledge that both

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autograft and allograft FCL reconstruction can result in similar outcomes when performed with

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patellar tendon ACLR. Subjective patient outcomes focusing on pain, disability and dysfunction

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can help establish the efficacy of different treatment options when no gold standard exists. In this

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case, comparing the use of hamstring autograft vs. allograft, there were no significant differences

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in patient reported outcomes (SF12 MCS and PCS, WOMAC, Lysholm and Tegner) at an

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average of 3.6 years postoperatively. In addition, patients who underwent combined ACLR and

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FCLR with hamstring allograft or autograft had similarly improved function and return to

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activities regardless of graft choice (Tegner: 5.1 vs. 5.4, respectively; p = 0.60).

225 Ligament reconstruction in the knee can be performed with either autograft or allograft tissue.

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The benefits of allograft tissue include lack of surgical morbidity of tendon harvest, decreased

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operative time, and may be required when autograft options have been previously harvested or

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are to be used for other ligament grafts for a multiligament knee reconstruction procedure

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requiring multiple grafts.35–37 However, allograft tendons have potential disadvantages including

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increased cost, decreased mechanical properties due to tissue age and sterilization processes,

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potential disease transmission, availability of allograft tissue banks, potential increased graft

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failure in younger patients, and patient preference.38 In the case of multiple ligament knee

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injuries, graft choices can be limited and thus choice of FCL graft may be limited based on

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availability. FCL reconstruction with either autograft or allograft evaluating both clinical and

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radiographic outcomes has yet to be performed to ensure maintained integrity and patient

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satisfaction after knee ligament reconstruction. Clinical studies comparing autograft versus

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allograft for ligament reconstruction procedures help the clinician and patient make an informed

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decision of graft choice without compromising the clinical outcome.

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Addressing the lateral ligamentous complex in the setting of ACL tears has been shown both

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clinically and biomechanically to be of utmost importance to prevent increased strain on the

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ACL graft as well as improve clinical outcomes.8,18,33,34,39–41 Dhillon et. al. demonstrated that

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patients with increased varus laxity after ACLR did clinically worse while it has been shown that

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combined ACL/FCL reconstructions when addressed concomitantly leads to reliable

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improvements and function post-operatively.39,42 As a result, this study demonstrates that graft

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choice with fibular collateral ligament reconstruction, either autograft or allograft, leads to

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improvement in both stability and functional outcomes giving the surgeon more flexibility in

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preventing residual varus laxity after ACLR.

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250 One of the strengths of this study was that graft integrity was also assessed using stress

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radiographs. Kane et. al. demonstrated improved sensitivity and specificity compared to MRI

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with the utilization of varus stress radiographs with absolute difference of 2.1 mm SSD

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significant for a complete grade III FCL tear.28 The current study found no significant difference

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in side-to-side varus stress gapping when comparing allograft and autograft at the 6 months post-

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operative visit. Furthermore, the absolute differences were not significantly different between

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autograft and allograft (0.49 mm versus 0.15 mm), and both values fell well below the 2.1 mm

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cut-off for FCL insufficiency. Furthermore, LaPrade et. al. demonstrated that quantitative stress

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radiographs do not change significantly between 6-months and 2-years after surgery for FCLR.19

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Thus, it may be inferred from our findings that the stress radiographs in both graft groups would

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main equivalent at 2-years after surgery. However, future research should evaluate long-term

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outcomes following FCLR with hamstring autograft and allograft to determine if varus knee

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stability remains unchanged.

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264 Limitations

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There are confounding variables with concomitant surgeries performed which could impact

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clinical outcomes and were not accounted for in this study. Specifically, all patients underwent a

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concomitant ACLR, which may affect the generalizability of results to isolated FCLR patients.

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In addition, ACL graft choice was made by patient preference after thorough counseling of risks

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and benefits of either graft which can be a confounding factor when looking at subjective

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outcomes because older patients tended to opt for allograft reconstruction. In addition, various

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demographic variables were not included in the analysis to include BMI, gender, sport type, nor

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ACL graft type. These variables can directly affect activity level and failure rate and can be a

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basis of future research when evaluating FCLR in the setting of ACLR. Despite this limitation,

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this study serves as a guideline for counseling patients on various graft options for FCL

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reconstruction reassuring both patient and surgeon that allograft remains a viable and effective

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method of treatment for FCL reconstructions in the active patient.

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Conclusion

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There were no differences in varus stress laxity at 6-months postoperatively or clinical outcome

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scores at minimum 2-year postoperatively between patients with FCL reconstructions with either

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autograft or allograft. This study demonstrates that both hamstring autografts and allografts for

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FCL reconstructions offer reliable and similar radiographic and clinical results at short-term

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follow-up.

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18. Coobs BR, LaPrade RF, Griffith CJ, Nelson BJ. Biomechanical Analysis of an Isolated Fibular (Lateral) Collateral Ligament Reconstruction Using an Autogenous Semitendinosus Graft. Am J Sports Med. 2007;35(9):1521-1527. doi:10.1177/0363546507302217

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19. LaPrade RF, Spiridonov SI, Coobs BR, Ruckert PR, Griffith CJ. Fibular Collateral Ligament Anatomical Reconstructions: A Prospective Outcomes Study. Am J Sports Med. 2010;38(10):2005-2011. doi:10.1177/0363546510370200

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20. Levy BA, Dajani KA, Morgan JA, Shah JP, Dahm DL, Stuart MJ. Repair versus Reconstruction of the Fibular Collateral Ligament and Posterolateral Corner in the Multiligament-Injured Knee. Am J Sports Med. 2010;38(4):804-809. doi:10.1177/0363546509352459

350 351 352 353

21. Hardy A, Casabianca L, Andrieu K, Baverel L, Noailles T. Complications following harvesting of patellar tendon or hamstring tendon grafts for anterior cruciate ligament reconstruction: Systematic review of literature. Orthop Traumatol Surg Res. 2017;103(8):S245-S248. doi:10.1016/j.otsr.2017.09.002

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22. Papalia R, Franceschi F, D’Adamio S, Diaz Balzani L, Maffulli N, Denaro V. Hamstring Tendon Regeneration After Harvest for Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthrosc J Arthrosc Relat Surg. 2015;31(6):1169-1183. doi:10.1016/j.arthro.2014.11.015

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24. Simonian PT, Harrison SD, Cooley VJ, Escabedo EM, Deneka DA, Larson RV. Assessment of morbidity of semitendinosus and gracilis tendon harvest for ACL reconstruction. Am J Knee Surg. 1997;10(2):54-59.

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25. Soon M, Neo CPC, Mitra AK, Tay BK. Morbidity following anterior cruciate ligament reconstruction using hamstring autograft. Ann Acad Med Singapore. 2004;33(2):214-219.

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26. Tashiro T, Kurosawa H, Kawakami A, Hikita A, Fukui N. Influence of Medial Hamstring Tendon Harvest on Knee Flexor Strength after Anterior Cruciate Ligament Reconstruction: A Detailed Evaluation with Comparison of Single- and Double-Tendon Harvest. Am J Sports Med. 2003;31(4):521-529. doi:10.1177/03635465030310040801

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33. LaPrade RF, DePhillipo NN, Cram TR, et al. Partial Controlled Early Postoperative Weightbearing Versus Nonweightbearing After Reconstruction of the Fibular (Lateral) Collateral Ligament: A Randomized Controlled Trial and Equivalence Analysis. Am J Sports Med. 2018;46(10):2355-2365. doi:10.1177/0363546518784301

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Table 1: Preoperative Patient Reported Outcome Scores

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SF12 PCS SF12 MCS WOMAC Pain WOMAC Stiff WOMAC Activity WOMAC TOTAL

FCLR Autograft Group Preoperative Score 35.7 ± 8.6 [33.2-38.2] 51.2 ± 10.6 [48.1-54.3] 7.1 ± 4.2 [5.9-8.4] 3.3 ± 1.9 [2.8-3.9] 24.4 ± 15.5 [19.8-28.9] 34.8 ± 20.7 [28.8-40.8]

FCLR Allograft Group Preoperative Score 41.2 ± 11.5 [35.8-46.6] 50.1 ± 12.0 [44.5-55.7] 8.2 ± 7.0 [4.8-11.7] 3.7 ± 2.4 [2.6-4.9] 28.0 ± 22.7 [16.7-39.3] 39.8 ± 31.5 [24.2-55.5]

P-value 0.320 0.704 0.447 0.450 0.460 0.452

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LYS_KNEE IKDC TEGNER 424 425 426 427 428 429 430 431

50.1 ± 22.2 [43.5-56.7] 74.4 ± 8.9 [70.3-78.5] 2.5 ± 2.3 [1.6-3.4]

45.9 ± 30.7 [30.2-61.7] 80.6 ± 8.6 [71.6-89.6] 2.5 ± 2.7 [1.0-3.9]

0.552 0.143 0.984

Table 1: Patient reported preoperative scores (mean ± SD) comparing patients who underwent fibular collateral ligament reconstruction with either allograft or autograft tendon. (SF, short form; PCS, physical composite score; MCS, mental composite score; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Score; LYS, Lysholm; IKDC, international knee documentation committee)

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Table 2. Postoperative Patient Reported Outcome Scores FCLR Autograft Group FCLR Allograft Group P-value Postoperative Score Postoperative Score SF12 PCS 52.3 ± 8.2 [50.0-54.7]* 48.9 ± 9.5 [44.4-53.3]* 0.134 SF12 MCS 45.7 ± 7.9 [52.4-56.9] 53.6 ± 9.6 [49.1-58.1]* 0.642 WOMAC Pain 1.7 ± 2.5 [1.0-2.4] 3.0 ± 3.9 [1.1-4.8] 0.116 WOMAC Stiff 1.2 ± 1.5 [0.7-1.6] 2.0 ± 2.0 [1.1-2.9] 0.061 WOMAC Activity 4.2 ± 7.9 [1.9-6.5]* 6.6 ± 1.7 [3.0-10.2]* 0.252 WOMAC TOTAL 7.0 ± 11.3 [3.8-10.3]* 11.6 ± 13.3 [5.3-17.8]* 0.158 LYS_KNEE 85.0 ± 15.1 [80.7-89.4]* 83.1 ± 14.3 [76.1-90.0]* 0.622 IKDC 72.0 ± 6.2 [70.2-73.8] 70.3 ± 7.0 [67.0-73.7] 0.337 TEGNER 5.4 ± 2.1 [4.8-6.0]* 5.1 ± 2.3 [4.0-6.2]* 0.601 SATISFACTION 8.3 ± 2.6 [7.5-9.0] 7.4 ± 2.8 [6.1-8.7] 0.218 432 433 Table 2. Patient reported postoperative scores (mean ± SD) comparing patients who underwent fibular 434 collateral ligament reconstruction with either allograft or autograft tendon. (SF, short form; PCS, 435 physical composite score; MCS, mental composite score; WOMAC, Western Ontario and McMaster 436 Universities Osteoarthritis Score; LYS, Lysholm; IKDC, international knee documentation committee). 437 438 Table 3. FCLR Autograft Change in Clinical Outcome Scores FCLR Autograft Group FCLR Autograft Group P-value Preoperative Score Postoperative Score SF12 PCS 35.7 ± 8.6 [33.2-38.2] 52.3 ± 8.2 [50.0-54.7]* < 0.001 SF12 MCS 51.2 ± 10.6 [48.1-54.3] 45.7 ± 7.9 [52.4-56.9] 0.072 WOMAC Pain 7.1 ± 4.2 [5.9-8.4] 1.7 ± 2.5 [1.0-2.4] <0.001 WOMAC Stiff 3.3 ± 1.9 [2.8-3.9] 1.2 ± 1.5 [0.7-1.6] <0.001 WOMAC Activity 24.4 ± 15.5 [19.8-28.9] 4.2 ± 7.9 [1.9-6.5]* <0.001 WOMAC TOTAL 34.8 ± 20.7 [28.8-40.8] 7.0 ± 11.3 [3.8-10.3]* <0.001 LYS_KNEE 50.1 ± 22.2 [43.5-56.7] 85.0 ± 15.1 [80.7-89.4]* <0.001 IKDC 74.4 ± 8.9 [70.3-78.5] 72.0 ± 6.2 [70.2-73.8] 0.207 TEGNER 2.5 ± 2.3 [1.6-3.4] 5.4 ± 2.1 [4.8-6.0]* <0.001 439 Table 3. Pre- to post-operative clinical outcome scores (mean ± SD) in FCLR autograft cohort. * Denotes 440 improvements meeting MCID (minimal clinically important difference) or MDC (minimal detectable

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change. (SF, short form; PCS, physical composite score; MCS, mental composite score; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Score; LYS, Lysholm; IKDC, international knee documentation committee).

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Table 4. FCLR Allograft Change in Clinical Outcome Scores FCLR Allograft Group FCLR Allograft Group P-value Preoperative Score Postoperative Score SF12 PCS 41.2 ± 11.5 [35.8-46.6] 48.9 ± 9.5 [44.4-53.3]* 0.028 SF12 MCS 50.1 ± 12.0 [44.5-55.7] 53.6 ± 9.6 [49.1-58.1]* 0.311 WOMAC Pain 8.2 ± 7.0 [4.8-11.7] 3.0 ± 3.9 [1.1-4.8] 0.006 WOMAC Stiff 3.7 ± 2.4 [2.6-4.9] 2.0 ± 2.0 [1.1-2.9] 0.018 WOMAC Activity 28.0 ± 22.7 [16.7-39.3] 6.6 ± 1.7 [3.0-10.2]* <0.001 WOMAC TOTAL 39.8 ± 31.5 [24.2-55.5] 11.6 ± 13.3 [5.3-17.8]* <0.001 LYS_KNEE 45.9 ± 30.7 [30.2-61.7] 83.1 ± 14.3 [76.1-90.0]* <0.001 IKDC 80.6 ± 8.6 [71.6-89.6] 70.3 ± 7.0 [67.0-73.7] 0.006 TEGNER 2.5 ± 2.7 [1.0-3.9] 5.1 ± 2.3 [4.0-6.2]* 0.004 446 Table 4. Pre- to post-operative clinical outcome scores (mean ± SD) in FCLR allograft cohort. * Denotes 447 improvements meeting MCID (minimal clinically important difference) or MDC (minimal detectable 448 change. (SF, short form; PCS, physical composite score; MCS, mental composite score; WOMAC, 449 Western Ontario and McMaster Universities Osteoarthritis Score; LYS, Lysholm; IKDC, international knee 450 documentation committee). 451

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