5,557

A Prospective Randomized Investigation Comparing Functional Outcomes of Syndesmotic Suture-Button Fixation to Screws

Eric Giza, MD1; Todd Oliver, MD2; Patrick Barousse, MPH, MD1; Tyler Allen BS3; Trevor Shelton, MS, MD1; Aida Sarcon, MD4*; Ashoke Sathy, MD5; Medardo Richard Maroto, MD6; David N. Garras, MD7; Wade Faerber, DO8; Johnny Lin, MD9; James P. Stannard, MD10; Brett D. Crist, MD, FACS10; Gregory J. Della Rocca, MD, PhD, FACS10; Kyle Fiala, DPM10; Benjamin Summerhays, DPM10; David A. Volgas, MD10; James Ronan, BS11; Michelle Vogt, BS2; Vicki Jones B.A10; Jonathan Fech, B.S10; Emma Briggs, M.Eng2; Christopher Kreulen, MD,MS1

1 Department of Orthopaedic surgery, The University of California Davis, Sacramento, CA, United States
2 Columbia Orthopedic Group, Columbia, MO, United States
3 University of Nevada, Reno School of Medicine, Reno, NV, United States
4 Department of General Surgery, Mayo Clinic, Rochester, MN, United States
5 Department of Orthopaedic Surgery, The University of Texas Southwestern Medical Center, Dallas, TX, United States
6 Department of Orthopaedic Surgery, Spectrum Health, Grand Rapids, MI, United States
7 Midwest Orthopedic Consultants, University of Illinois, Chicago, IL, United States
8 Riverside University Health System, Moreno Valley, CA, United States
9 Midwest Orthopedics at Rush, Chicago, IL, United States
10 Department of Orthopaedic Surgery, University of Missouri, Columbia, MO, United States 11 Arthrex, Inc, Naples, FL, United States
Source of funding: Arthrex Inc.

Conflict-of-interest statement: The author(s) declare(s) that there is no conflict of interest regarding the publication of this paper.

Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http: //creativecommons.org/licenses/by-nc/4.0/

Correspondence to: Aida K. Sarcon, MD, Resident Physician, Mayo Clinic Dept of General, Surgery, 200 1st, St, SW, Rochester, MN 55905.
Email: aidasarcon@gmail.com
Received: April 1, 2020
Revised: June 6, 2020
Accepted: June 10 2020
Published online: September 7, 2020

ABSTRACT

AIM: To compare functional outcomes and adverse events of surgically treated syndesmotic injuries with either screw(s) or suture-button(s). It was hypothesized that suture-button fixation would provide equal clinical results with fewer adverse events.

MATERIALS AND METHODS: Multi-center, randomized clinical study. Sixty-five subjects with confirmed acute syndesmotic injury requiring surgical intervention were enrolled. Subjects were randomized and treated with either suture-button or screw fixation. Foot and Function Index pain, disability, and activity scores, American Orthopaedic Foot and Ankle Society scores, and the Visual Analogue Scale for pain were reported up to 12-months. The adverse events were also collected. The forty subjects with complete data up to one year (n = 40; suture-button = 18 and screw = 22) were included in analysis. Single or multiple screws or suture-button implants were based on surgeon preference and patients’ characteristics.

RESULTS: There was statistically significant improvement in Foot and Function Index and American Orthopaedic Foot and Ankle Society scores with both techniques (p < 0.05). Visual Analog Scale scores improved significantly with the screw technique (p < 0.05) but not with the suture button technique.

CONCLUSION: One-year clinical data suggests that acute syndesmotic injuries can be effectively treated with either technique. A possible benefit of suture button fixation may be a lower occurrence of adverse clinical events.

Key words: Syndesmosis, syndesmotic, screw, suture button

© 2020 The Authors. Published by ACT Publishing Group Ltd. All rights reserved.

Giza E, Oliver T, Barousse P, Allen T, Shelton T, Sarcon A, Sathy A, Maroto MR, Garras DN, Faerber W, Lin J, Stannard JP, Crist BD, Rocca GJD, Fiala K, Summerhays B, Volgas DA, Ronan J, Vogt M, Jones V, Fech J, Briggs E, Kreulen C. A Prospective Randomized Investigation Comparing Functional Outcomes of Syndesmotic Suture-Button Fixation to Screws. International Journal of Orthopaedics 2020; 7(4): 1322-1328 Available from: URL: http://www.ghrnet.org/index.php/ijo/article/view/2784

INTRODUCTION

The syndesmosis is a ligamentous articulation between the distal tibia and fibula; it is comprised of the anterior inferior tibiofibular ligament, interosseous ligament, and posterior inferior tibiofibular ligament. Reportedly, 1 to 18% of ankle sprains involve the syndesmotic ligaments[1]. The mechanism may involve either a pronation-external rotation or an excessive external rotation injury.

Compared to the more commonly sprained lateral ankle ligaments, syndesmotic injuries require a greater recovery time[2,3]. Failure to properly treat syndesmosis instability can cause lateral displacement of the talus with a 40% decrease in tibiotalar surface contact area.[4] Operative syndesmotic fixation can stabilize the ankle and prevent degenerative changes to the ankle[5,6].

The ideal surgical technique to address syndesmotic injuries has been debated. One option involves rigid, screw fixation across the syndesmosis articulation. One or multiple screw(s) are used to stabilize the ankle and facilitate ligamentous healing. Depending on the surgeon’s preference and patient’s symptoms, screws may require subsequent removal. As the syndesmosis has an amplified rotational and translational motion during the gait cycle[7], some electively remove screws to preserve motion and to prevent symptoms. However, this exposes the patient to another operation, and elective screw removal remains controversial. One study found that 65% of surgeons routinely remove screws[8]. The ideal timing of removal is also unknown, and premature removal can result in syndesmotic diastasis[6,9].

Since the introduction of the suture-button (SB) device in the early 2000s, several studies have demonstrated its advantages over screw(s). These include fewer malreductions[10], reduced implant failure[5,6,11,12], and a quicker recovery time[6,11,12]. The SB construct also provides a more anatomic and physiologic method of syndesmotic fixation[13].

Over the years, there has been a growing interest in comparing the two modes of fixation. A recent meta-analysis of five major studies comparing SB to screws revealed significantly lower reoperation rate with SB fixation[14]. Although the authors found clinically better American Orthopedic Foot and Ankle Society(AOFAS) scores and malreduction rates, the pooled analysis ultimately did not reveal any statistically signifigant difference in these outcomes due to study heterogeneity[14]. Thus, continued research on the topic is warranted.

Several randomized controlled trials (RCT) have compared the two techniques[13,15-19]. However, only one RCT was performed in the U.S.A with a sample size of 24 patients[15]. To the best of our knowledge, there are no larger level I studies from the U.S.A. The purpose of this multicenter RCT was to compare functional outcomes and adverse events of surgically treated syndesmotic injuries with either screw(s) or SB device(s). It was hypothesized that SB fixation would provide equal clinical results with fewer adverse events.

METHODS

Design

This was a prospective, multi-institutional, (5 study centers, U.S.A) RCT comparing treatment of acute syndesmotic injury with either screw or SB (Tightrope, Arthrex, Inc, Naples, FL) fixation. The follow-up period was up to one year. Institutional Review Board approval was obtained from all participating study centers. Informed consent was obtained from all study subjects. Randomized allocations were kept in sealed envelopes which were revealed to the study surgeon intraoperatively. Operations were performed prospectively by specialty trained orthopaedic foot and ankle and/or trauma surgeons. Subjects were treated by 9 surgeons from 2011 to 2014.

The study’s procedures are graphically illustrated (Figure 1). Patients with acute ankle trauma and suspected syndesmosis instability on exam or radiography were initially screened (Table 1). Voluntary informed consent was obtained from potential subjects. Preoperative functional outcome scores were evaluated. Intraoperatively, syndesmotic injuries were confirmed via fluoroscopy, and with ankle arthroscopy at the discretion of the surgeon. Only subjects with intraoperatively confirmed unstable syndesmosis injuries were included. Subjects were randomized intraoperatively into either treatment with syndesmotic screw(s) or SB(s). Single or multiple screws or SBs were based on the study surgeon’s preference, intraoperative findings, and the patient’s characteristics (i.e. patient body mass index, amount of displacement and the potential stability of the construct). Tourniquet time was evaluated. The postoperative functional outcome scores and adverse events were evaluated.

Figure 1 Flow chart of the study’s procedures.

Table 1 Inclusion and exclusion criteria.
Inclusion CriteriaExclusion CriteriaIntraoperative Exclusion Criteria
  1. 18 to 65 years old.
  2. Complete history and physical exam.
  3. Isolated acute syndesmosis injury requiring operative treatment.
  4. Clinical & radiographic confirmation of an acute syndesmosis injury.
  5. Voluntary informed consent.

Prior surgery.

Chronic syndesmosis injury.

Ankle fracture malunion.

History of septic ankle arthritis.

Multi-system or multi-limb trauma.

Associated pilon fracture.

Stable syndesmosis injury at the time of surgical intervention

Operative technique

The operative technique is described by Anand et al[5]. Patients were positioned supine on the operating table and a tourniquet was applied to the lower extremity. Any associated fibular and/or tibial fractures were fixed with standard techniques. Syndesmotic fixation in the neutral position was achieved using a reduction clamp. Mandatory clamping was included in the operative protocol in order to standardize the reduction between surgeons. Reduction was evaluated via fluoroscopy under direct visualization of the syndesmosis when possible.

Postoperative Rehabilitation

Postoperatively, all patients were non-weight bearing for six weeks. During the initial 2 weeks, patients were in a short leg plaster splint until the sutures were removed. From weeks 2 to 6, patients were transitioned to a controlled ankle motion (CAM) boot. From weeks 3 to 6, patients were permitted gentle active and passive range of motion of the ankle to prevent stiffness. During weeks 6 to 8, patients were advanced to weight bearing in the CAM boot with increased range of motion, and weaned from the CAM boot to the air cast. Lastly, during weeks 10 to 12, patients could return to normal activities.

Outcomes

The primary outcomes were functional scores and postoperative adverse events. The outcomes reported were the Foot and Function Index (FFI) pain, disability, and activity scores, American Orthopaedic Foot and Ankle Society (AOFAS) scores, and the Visual Analogue Scale (VAS) score for measurement of pain. A lower VAS or FFI score, or a higher AOFAS score indicates a better outcome. The FFI and VAS scores are reported preoperatively, as well as postoperatively at 6 weeks, 3 months, 6 months, and 12 months. The AOFAS scores are reported postoperatively at 6 weeks, 3 months, 6 months and 12 months. The percentage and type of postoperative adverse events were evaluated. The potential adverse events included, but were not limited to: infection, symptomatic hardware, hardware loosening, hardware breakage, loss of reduction, and reoperation.

Statistical Analysis

Computations were performed using JMP® Pro statistical software (version 14.0, http://www.jmp.com). Statistical significance was determined at alpha of less than or equal to 0.05. Normality was assessed for continuous variables using a Shapiro-Wilks Test. Continuous variables between groups were compared with a Wilcoxon Rank Sums Test while categorical variables were compared with a Fisher’s exact test. The Kruskal-Wallis test was used to compare the outcome scores for differences at each timepoint. The median and interquartile ranges were reported for the outcome scores. If a difference was detected, a post-hoc Wilcoxon test was used to determine statistical differences between timepoints as denoted by superscripts A, B, C, and D (i.e. a statistical difference does not exist between groups if there is a repeating letter). The patient characteristics were reported with the mean value, +/- standard deviation (SD), and range (Microsoft® Excel, version 16.27).

RESULTS

Sixty-six subjects were initially assessed for eligibility, and 65 subjects were enrolled (Figure 2). However, only subjects with near complete clinical outcomes up to one-year were included in the final analysis (n = 40). Twenty-two of the 40 (55%) received screw fixation, and 18 (45%) received SB (Figure 3). The patient characteristics are listed in Table 2. The most frequent mechanism of injury in either group was slip and fall, and a majority sustained a concomitant Weber B or C fibula fracture.

Figure 2 CONSORT Flow chart.

Figure 3 A: Xray of the ankle demonstrating syndesmosis screw fixation; B: Xray of the ankle demonstrating syndesmosis suture-button fixation.

Table 2 Patient characteristics (mean +/-SD; range).
  ScrewSuture Button
Agen=15n=15
31 ± 938 ± 15
(Range, 19 to 48)(Range, 18 to 61)
BMIn=5n=7
31 ± 430 ± 4
(Range, 26 to 36)(Range, 24 to 35)
L:R11:118:10
MOIn=21n=18
Slip/fall1315
Sports71
ADL12
M:Fn=16n=15
 9:078:07
Smokingn=12n=13
No1011
Yes22
Preoperative Medial clear space(mm)n=19n=16
4.7 ± 2.96.7 ± 3.9
(Range, 2 to 14) (Range, 0 to 16)
Preoperative tib-fib overlap(mm)n=19n=15
2.1 ± 4.31.2 ± 1.7
(Range, -11 to 10) (Range, -2 to 4)
Concomitant fracturen=22n=18
Fibula shaft21
Lateral malleolus10
Medial malleolus03
Posterior malleolus01
Weber A01
Weber B64
Weber C138
Abbreviation: BMI, Body Mass index; MOI, mechanism of injury; ADL, activities of daily living.

Most subjects with screw fixation had either one or two screws placed (n = 21; one screw = 11, two screws = 8, three screws = 1 and four screws = 1). One subject had screws placed, but the number of screws was not reported. A majority of subjects in the SB group had only one SB placed (n = 18, one SB = 14, and two SB = 4). For 17 subjects, the type of SB was recorded: nine had the knotless type, and 8 had a SB that required tying a minimum of five knots after placement. Tourniquet time was available for 31 subjects. The average tourniquet time for the screw fixation was 64.3 ± 30.9 minutes (n = 20; range, 15 to 121 minutes). The average tourniquet time for SB was 65.7 ± 29.0 minutes (n = 15; range, 24 to 120 minutes).

The functional outcomes at the select time-points for those treated with syndesmotic screws are shown in Table 3. Subjects had statistically improved AOFAS scores from 6-weeks postoperative until the 12-month visit. There was a statistical pre- to postoperative improvement in VAS scores between 6-months and 12-months. There was a statistical pre- to postoperative improvement in FFI pain scores at 3, 6, and 12-month visits; there was also continued improvement between the 6-weeks and 3, 6, and 12-month visits. There were also improved disability scores from preoperative scores to 3, 6, and 12-months postoperative visits. The patients’ activity limitations also significantly improved from preoperative at the 3, 6, and 12-months postoperative visits.

Table 3 Clinical outcome scores for patients with Screw Fixation (number of subjects reported in each visit).
Outcome ScorePreoperative6 Week Postoperative3 Month Postoperative6 Month Postoperative1 Year PostoperativeP-Values
AOFAS-58 [49, 75]A83 [75, 89]B92 [85, 99]C90 [84, 100]C< 0.001
 (N = 22)(N = 20)(N = 18)(N = 20)
VAS5 [0, 8]A3 [2, 5]A,B2 [1, 3]A,C1 [0, 3]C1 [0, 3]C0.01
(N = 22)(N = 22)(N = 21)(N = 21)(N = 22)
FFI Pain9 [0, 10]A7 [2, 8]A2 [1, 4]B1 [0, 4]B,C0 [0, 1]C< 0.001
(N = 21)(N = 18)(N = 21)(N = 21)(N = 22)
FFI Disability8 [0, 10]A6 [4, 8]A3 [1, 7]B2 [0, 5]B,C1 [0, 3]C< 0.001
(N = 22)(N = 22)(N = 21)(N = 21)(N = 22)
FFI Activity Limit9 [0, 10]A8 [4, 9]A1 [0, 6]B0 [0, 3]B,C0 [0, 1]C< 0.001
(N = 22)(N = 22)(N = 21)(N = 21)(N = 22)
Data presented in median [interquartile range]. P-Values reported using Kruskal-Wallis test. Superscript letters (A, B) indicate where statistical differences exist between groups using a post-hoc Wilcoxon Test.Abbreviations: American Orthopedic Foot and Ankle society score, AOFAS; Visual Analogue Scale score, VAS; Foot Function Index score; FFI.

Table 4 describes the functional outcomes scores for patients treated with SB technique. Similar to the screw fixation group, there were statistically significant improvements in the postoperative AOFAS scores between 6 weeks until the 12-month visit and maintained scores between 6-month and 12-month visits. Unlike syndesmotic screws, there were no differences in VAS scores. Patients with SB initially had increased FFI pain scores which significantly decreased at the 6- and or 12-month visit; this was also maintained without symptom deterioration between the 6- and 12-month visit. Although there was a significant increase in the FFI disability scores at the 6-week visit compared to preoperative, symptoms significantly improved during the subsequent visits. A similar trend was observed with the FFI activity scores, which ultimately resulted in similar scores between preoperative and the final 12-month visit.

Table 4 Clinical outcome scores for patients with Suture Button Fixation (number of subjects reported in each visit).
Outcome ScorePreoperative6 Week Postoperative3 Month Postoperative6 Month Postoperative1 Year PostoperativeP-Values
AOFAS- 63 [58, 67]A76 [71, 88]B90 [83, 96]C98 [88, 100]C< 0.001
 (N = 16)(N = 17)(N = 17)(N = 17)
VAS1 [0, 8]1 [0,3]2 [1, 3]1 [0, 2]0 [0, 2]0.1357
(N = 18)(N = 17)(N = 17)(N = 18)(N = 18)
FFI Pain0 [0, 10]A,B,C4 [1, 8]A2 [0, 3]A0 [0, 3]B0 [0, 1]C0.0154
(N = 18)(N = 9)(N = 16)(N = 17)(N = 18)
FFI Disability0 [0, 9]A,C8 [4, 10]B3 [2, 5]A1 [0, 4]A,C0 [0, 1]C< 0.001
(N = 18)(N = 15)(N = 17)(N = 17)(N = 18)
FFI Activity Limit0 [0, 10]A,B,C8 [3, 9]A2 [0, 5]B0 [0, 1]C,D0 [0, 0]D< 0.001
(N = 18)(N = 15)(N = 17)(N = 17)(N =18)
Data presented in median [interquartile range]. P-Values reported using Kruskal-Wallis test. Superscript letters (A, B) indicate where statistical differences exist between groups using a post-hoc Wilcoxon Test.Abbreviations: American Orthopedic Foot and Ankle society score, AOFAS; Visual Analogue Scale score, VAS; Foot Function Index score; FFI

With the exception of significantly higher VAS scores at postoperative 6-weeks in patients treated with syndesmotic screws, there were no statistical differences between the two fixation methods (Table 5). With respect to postoperative adverse events, 7 out of the 22 (32%) subjects treated with syndesmotic screws had complications; there were 5 broken screws, one symptomatic screw, and one loose screw; two of these patients had the screws removed. Conversely, only one of 18 (6%) with the SB technique had an adverse event which was a symptomatic knotted device requiring removal. However, the difference in rates of adverse events was not statistically significant (p = 0.054).

Table 5 Clinical outcome scores comparing patients who received Suture button to screw fixation(N represents the number of subjects reported in each visit).
Outcome ScoreScrew FixationTightRopeP-Values
Preoperative
VAS5 [0, 8]1 [0, 8]0.234
(N = 22)(N = 18)
FFI Pain9 [0, 10]0 [0, 10]0.108
(N = 21)(N = 18)
FFI Disability8 [0, 10]0 [0, 9]0.152
(N = 22)(N = 18)
FFI Activity Limit9 [0, 10]0 [0, 10]0.165
(N = 22)(N = 18)
6 Week Postoperative
AOFAS58 [49, 75]63 [58, 67]0.668
(N = 22)(N = 16)
VAS3 [2, 5]1 [0, 3]0.012
(N = 22)(N = 17)
FFI Pain7 [2, 8]4 [1, 8]0.468
(N = 18)(N = 9)
FFI Disability6 [4, 8]8 [4, 10]0.389
(N = 22)(N = 15)
FFI Activity Limit8 [4, 9]8 [3, 9]0.595
(N = 22)(N = 15)
3 Months Postoperative
AOFAS83 [75, 89]76 [71, 88]0.492
(N = 20)(N = 17)
VAS2 [1, 3]2 [1, 3]0.717
(N = 21)(N = 17)
FFI Pain2 [1, 4]2 [0, 3]0.731
(N = 21)(N = 16)
FFI Disability3 [1, 7]3 [2, 5]0.79
(N = 21)(N = 17)
FFI Activity Limit1 [0, 6]2 [0, 5]0.976
(N = 21)(N = 17)
6 Months Postoperative
AOFAS92 [85, 99]90 [83, 96]0.539
(N = 18)(N = 17)
VAS1 [0, 3]1 [0, 2]0.662
(N = 21)(N = 18)
FFI Pain1 [0, 4]1 [0, 3]0.975
(N = 21)(N = 17)
FFI Disability2 [0, 5]1 [0, 4]0.372
(N = 21)(N = 17)
FFI Activity Limit0 [0, 3]0 [0, 1]0.453
(N = 21)(N = 17)
1 Year Postoperative
AOFAS90 [84, 100]98 [88, 100]0.353
(N = 20)(N = 17)
VAS1 [0, 3]0 [0, 2]0.201
(N = 22)(N = 18)
FFI Pain0 [0, 1]0 [0, 1]0.329
(N = 22)(N = 18)
FFI Disability1 [0, 3]0 [0, 1]0.173
(N = 22)(N = 18)
FFI Activity Limit0 [0, 1]0 [0, 0]0.114
(N = 22)(N = 18)
Data presented in median [interquartile range].P-Values reported using a Wilcoxon Rank Sums Test.Abbreviations: American Orthopedic Foot and Ankle society score, AOFAS; Visual Analogue Scale score, VAS; Foot Function Index score; FFI.

DISCUSSION

The authors report short term clinical outcomes after randomized treatment of acute syndesmosis injuries with either screw or SB. The one-year clinical outcomes of this investigation suggest that either method is effective in treating acute syndesmosis injuries as both techniques lead to a statistically significant improvement in FFI and AOFAS scores. Although we did not find a statistical difference in the number of adverse events, patients with SB fixation had a clinically lower complication rate (6% vs 32%).

Studies have shown greater improvement in clinical outcomes following fixation with the SB technique versus screws[13,16,20,21]. A randomized clinical study by Andersen et al. revealed significantly higher AOFAS scores and lower pain with SB fixation[16]. Unlike the SB group, there were 7 cases of symptomatic diastasis with syndesmotic screws[16]. Laflamme et al also found statistically greater Olerud-Molander Ankle scores at one year and clinically higher AOFAS scores with the SB technique[13]. The screw fixation had a higher number of reoperations, and three patients experienced loss of reduction[13]. Stiene et al also found higher AOFAS scores (score of 92, n = 271, mean follow up of 22 months) compared to screw fixation (score of 85, n = 494, mean follow up of 38 months)[21]. The average time to weightbearing was also shorter with the SB technique compared to static fixation (6.0 versus 10.5 weeks)[21]. In our study, although subjects treated with SB fixation had higher AOFAS scores at 12-month postoperative visit, we were unable to achieve statistical significance, likely due to sample size.

The SB technique offers the advantage of lower adverse events. A systematic review by Zhang et al. revealed a 4% rate of SB removal compared to 40% with screws. Additionally, the reported screw removal rate may have been underestimated since screws routinely removed were excluded. Stiene et al. also found significantly higher screw removal rates (39% of 584 with screw versus 8% of 350 with SB)[21]. Recently, Sanders’ et al found that patients treated with screw fixation had both a statistically higher rate of malreduction (39% vs 15%) and reoperation rate (30% vs 4%) compared to SB[19].

Fewer reoperations are cost effective and beneficial for patients. Neary et al performed a cost analysis of SB to syndesmotic screw fixation[22]. Although the baseline cost of the SB device was greater than two cortical screws ($880.00 vs $65), SB was overall more cost effective. With a screw removal rate of 20%, and SB removal rate of 4%, the authors found that the total cost of two cortical screws was greater ($20,836 versus $19,354)[22]. The study found that for syndesmosis screws to be more cost effective, a removal rate of less than 10% is needed[22]. In another cost analysis study, Ramsey et al. found that SB fixation was the more cost effective technique if the screw removal rate was greater than 17.5%[23]. These findings can be extrapolated to the previously mentioned studies[11,21]; given an average screw removal rate of 40%, both of the aforementioned investigations suggest that SB fixation is the more cost-effective approach for the majority of United States hospitals and clinical practices.

In agreement with the literature, our data revealed a clinically higher adverse events rate for syndesmotic screws compared to SB fixation (32% vs 6%). The knotted technique may influence the rate of SB removal. Forschner et al. found a relatively high SB removal rate of 26% (5/19) which was attributed to persistent skin irritation due to the suture knot prominence[20]. In the present study, only one subject with SB fixation had an adverse event which also required device removal, likely as a result of the knotted technique. The new knotless version of the SB has shown promise in reducing lateral skin irritation[17].

There are limitations to the present study including the short duration of follow-up. A longer follow-up evaluating functional outcomes and adverse events can shed additional light onto the clinical differences between the two techniques. The study’s small sample size was also a limitation. This may have affected the ability to detect differences and/or similarities between the two fixation techniques. Although the multi-institutional design of our study allowed for an increase in subject enrollment, there were multiple surgeons performing the procedures. However, all surgeons had experience with both techniques, and a standardized operative protocol was in place. The randomization design ensured there was no selection bias based on site or preference of fixation.

The randomized design of the study is a major strength which allowed for prospective comparison between two commonly performed surgical techniques. We also collected preoperative functional outcome scores, and thus minimized recall bias. The authors feel that this study contributes to the literature by reinforcing the prior studies that show that treatment using the SB technique leads to fewer postoperative complications.

Conflict-of-interest statement

E.G received a grant from Arthrex, Inc during the conduct of the study, and receives consulting fees from Arthrex, Inc.

C.K receives personal fees and research/fellowship support from Arthrex, Inc.

T.O received a grant from Arthrex, Inc during the conduct of the study, and receives consultant fees and royalties from Arthrex, Inc.

J.P.S receives consulting fees from Arthrex, DePuy Synthes, Orthopedic Designs North America, and Smith and Nephew company. he reports grants from Arthrex, Coulter foundation, U.S Dept of Defense, and the NIH; he reports publishing royalties from Thieme; he is part of the editorial board of the Journal of Knee Surgery, and is affiliated with and or received fees from AOA, AO north America, AO foundation, and Mid-America Orthopaedic association.

B.D.C received a grant from Arthrex, Inc during the conduct of the study. Outside of the submitted work, he receives personal fees from KCI and Globus, and receives stock fees from the Orthopaedic Implant Company.

G.J.D.R received a grant from Arthrex, Inc during the conduct of the study. Outside of the submitted work, he recieves personal fees from Wright-Tornier and DePuy-Synthes, and stock fees from the Orthopaedic Implant Company and Mergenet Medical. He holds intellectual property in Intellectual Ventures.

D.A.V works for Synthes & AO faculty at national and international courses.

J.R is an employee of Arthrex, Inc.

All other authors have nothing to disclose.

REFERENCES

1. McCollum GA, van den Bekerom MP, Kerkhoffs GM, Calder JD, van Dijk CN. Syndesmosis and deltoid ligament injuries in the athlete. Knee Surg Sports Traumatol Arthrosc 2013; 21(6): 1328-37 [DOI: 10.1007/s00167-012-2205-1]; [PMID: 23052109]

2. Wright RW, Barile RJ, Surprenant DA, Matava MJ. Ankle syndesmosis sprains in national hockey league players. Am J Sports Med 2004; 32(8): 1941-5 [DOI: 10.1177/0363546504264581]; [PMID: 15572325]

3. Miller TL, Skalak T. Evaluation and treatment recommendations for acute injuries to the ankle syndesmosis without associated fracture. Sports Med 2014; 44(2): 179-88 [DOI: 10.1007/s40279-013-0106-1]; [PMID: 24127279]

4. Lloyd J, Elsayed S, Hariharan K, Tanaka H. Revisiting the concept of talar shift in ankle fractures. Foot Ankle Int 2006; 27(10): 793-6 [DOI: 10.1177/107110070602701006]; [PMID: 17054879]

5. Anand A, Wei R, Patel A, Vedi V, Allardice G, Anand BS. Tightrope fixation of syndesmotic injuries in Weber C ankle fractures: a multicentre case series. Eur J Orthop Surg Traumatol 2017; 27(4): 461-67 [DOI: 10.1007/s00590-016-1882-8]; [PMID: 28074301]

6. M AI, Holton J, Hassan AN, Matthana A. A Novel Suture Button Construct for Acute Ankle Syndesmotic Injuries; A Prospective Clinical and Radiological Analysis. Arch Bone Jt Surg 2018; 6(3): 189-95]; [PMID: 29911135]

7. Wang C, Yang J, Wang S, Ma X, Wang X, Huang J, Zhang C, Chen L, Xu J, Geng X, Wang K. Three-dimensional motions of distal syndesmosis during walking. J Orthop Surg Res 2015; 10: 166 [DOI: 10.1186/s13018-015-0306-5]; [PMID: 26499882]

8. Bava E, Charlton T, Thordarson D. Ankle fracture syndesmosis fixation and management: the current practice of orthopedic surgeons. Am J Orthop (Belle Mead NJ) 2010; 39(5): 242-6]; [PMID: 20567742]

9. Hsu YT, Wu CC, Lee WC, Fan KF, Tseng IC, Lee PC. Surgical treatment of syndesmotic diastasis: emphasis on effect of syndesmotic screw on ankle function. Int Orthop 2011; 35(3): 359-64 [DOI: 10.1007/s00264-010-1147-9]; [PMID: 21069524]

10. Westermann RW, Rungprai C, Goetz JE, Femino J, Amendola A, Phisitkul P. The effect of suture-button fixation on simulated syndesmotic malreduction: a cadaveric study. J Bone Joint Surg Am 2014; 96(20): 1732-8 [DOI: 10.2106/JBJS.N.00198]; [PMID: 25320200]

11. Zhang P, Liang Y, He J, Fang Y, Chen P, Wang J. A systematic review of suture-button versus syndesmotic screw in the treatment of distal tibiofibular syndesmosis injury. BMC Musculoskelet Disord 2017; 18(1): 286 [DOI: 10.1186/s12891-017-1645-7]; [PMID: 28676078]

12. Schepers T. Acute distal tibiofibular syndesmosis injury: a systematic review of suture-button versus syndesmotic screw repair. Int Orthop 2012; 36(6): 1199-206 [DOI: 10.1007/s00264-012-1500-2]; [PMID: 22318415

13. Laflamme M, Belzile EL, Bedard L, van den Bekerom MP, Glazebrook M, Pelet S. A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture. J Orthop Trauma 2015; 29(5): 216-23 [DOI: 10.1097/BOT.0000000000000245]; [PMID: 25260059]

14. McKenzie AC, Hesselholt KE, Larsen MS, Schmal H. A Systematic Review and Meta-Analysis on Treatment of Ankle Fractures With Syndesmotic Rupture: Suture-Button Fixation Versus Cortical Screw Fixation. J Foot Ankle Surg 2019; 58(5): 946-53 [DOI: 10.1053/j.jfas.2018.12.006]; [PMID: 31474406]

15. Coetzee JC, Ebeling PB. Treatment of syndesmoses disruptions: A prospective, randomized study comparing conventional screw fixation vs TightRope® fiber wire fixation – medium term results. SA orthopaedic Journal 2009: 32 -37.

16. Andersen MR, Frihagen F, Hellund JC, Madsen JE, Figved W. Randomized Trial Comparing Suture Button with Single Syndesmotic Screw for Syndesmosis Injury. J Bone Joint Surg Am 2018; 100(1): 2-12 [DOI: 10.2106/JBJS.16.01011]; [PMID: 29298255]

17. Colcuc C, Blank M, Stein T, Raimann F, Weber-Spickschen S, Fischer S, Hoffmann R. Lower complication rate and faster return to sports in patients with acute syndesmotic rupture treated with a new knotless suture button device. Knee Surg Sports Traumatol Arthrosc 2018; 26(10): 3156-64 [DOI: 10.1007/s00167-017-4820-3]; [PMID: 29224059]

18. Kortekangas T, Savola O, Flinkkila T, Lepojarvi S, Nortunen S, Ohtonen P, Katisko J, Pakarinen H. A prospective randomised study comparing TightRope and syndesmotic screw fixation for accuracy and maintenance of syndesmotic reduction assessed with bilateral computed tomography. Injury 2015; 46(6): 1119-26 [DOI: 10.1016/j.injury.2015.02.004]; [PMID: 25769201]

19. Sanders D, Schneider P, Taylor M, Tieszer C, Lawendy AR, Canadian Orthopaedic Trauma S. Improved Reduction of the Tibiofibular Syndesmosis With TightRope Compared With Screw Fixation: Results of a Randomized Controlled Study. J Orthop Trauma 2019; 33(11): 531-37 [DOI: 10.1097/BOT.0000000000001559]; [PMID: 31633643]

20. Forschner PF, Beitzel K, Imhoff AB, Buchmann S, Feuerriegel G, Hofmann F, Karampinos DC, Jungmann P, Pogorzelski J. Five-Year Outcomes After Treatment for Acute Instability of the Tibiofibular Syndesmosis Using a Suture-Button Fixation System. Orthop J Sports Med 2017; 5(4): 2325967117702854 [DOI: 10.1177/2325967117702854]; [PMID: 28508007]

21. Stiene A, Renner CE, Chen T, Liu J, Ebraheim NA. Distal Tibiofibular Syndesmosis Dysfunction: A Systematic Literature Review of Dynamic Versus Static Fixation Over the Last 10 Years. J Foot Ankle Surg 2019; 58(2): 320-27 [DOI: 10.1053/j.jfas.2018.08.050]; [PMID: 30612866]

22. Neary KC, Mormino MA, Wang H. Suture Button Fixation Versus Syndesmotic Screws in Supination-External Rotation Type 4 Injuries: A Cost-Effectiveness Analysis. Am J Sports Med 2017; 45(1): 210-17 [DOI: 10.1177/0363546516664713]; [PMID: 27601151]

23. Ramsey DC, Friess DM. Cost-Effectiveness Analysis of Syndesmotic Screw Versus Suture Button Fixation in Tibiofibular Syndesmotic Injuries. J Orthop Trauma 2018; 32(6): e198-e203 [DOI: 10.1097/BOT.0000000000001150]; [PMID: 29521685]

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