Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients.

The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction.

The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results.

To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.

Study Overview

• Status: Not yet recruiting
• Conditions: Syndesmotic Injuries
• Intervention / Treatment: Device: Arthrex Tightrope; Device: Synthes Fibulink

Detailed Description

Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients1,2. If not recognized and adequately reduced, injuries to the syndesmosis have shown to result in instability, persistent pain, and post-traumatic arthritis3. 11% of cases are accompanied by symptomatic advanced osteoarthritis after fixation of the syndesmosis4.

The gold standard for syndesmosis fixation has traditionally been screw fixation5. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction6-8. This has been speculated to be a result of the ankle syndesmosis, a dynamic construct, being inappropriately fixed with static fixation. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. Advantages with these designs include superior outcome scores, as well as lower rates of osteoarthritis and reoperation7,9,10. However, despite achieving improved joint mechanics, these systems have their drawbacks as well, such as infection or damage to the superficial medial neurovascular bundle9.

The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. It has been promoted as an implant that potentially provides both the fixation of a screw and flexibility of a suture to respect the dynamic nature of the ankle joint. Benefits of this design include eliminating damage to the medial neurovascular bundle and soft tissues, promoting physiologic motion of the ankle joint, and allowing improved tension control. In a case series with 14 patients that received the Fibulink implant, Desai found no complications with a mean follow-up of 9.5 months9. However, more long-term data is needed in order to draw any conclusions. The potential advantage of this system over suture button designs is that it incorporates the rigidity of screw fixation on top of the dynamic fixation of suture button implants. It also addresses the limitations of suture button designs, such as avoiding medial soft tissue disruption and lack of two-way tension control.

The comparison between screw fixation and suture button designs has been thoroughly investigated in the literature. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants. It is imperative to directly compare these methods so we can definitively assess their suitability and provide patients that sustain these injuries the best method of fixation in order to improve patient outcomes.

The purpose of this study is to compare radiographic and clinical outcomes in patients who sustain an acute ankle fracture with an associated syndesmosis injury by comparing two surgical treatments currently in the practice of the study investigators. The study will compare suture button fixation versus Fibulink implant in patients with this injury.

Inadequate syndesmosis fixation has been found to result in significant morbidity to patients, including persistent pain, instability, and post-traumatic arthritis. This emphasizes the need to assess the available methods of fixation in order to minimize negative long-term consequences. Currently, standard single screw fixation remains a common choice among orthopaedic surgeons. However, there is some evidence of superior outcomes with dynamic fixation, using designs such as the suture button or the Fibulink system, in terms of functional results, residual pain, and other measures. With an enhanced understanding of patient outcomes with these methods of fixation, we will better be able to determine more effective ways to manage these injures and offer guidance for optimal management and patient satisfaction.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Hughey; Phone Number: 619-532-9535; Email: ashley.e.hughey.ctr@health.mil

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
      • Contact: Ashley Hughey
      • Principal Investigator: Benjamin Wheatley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ankle fracture with associated syndesmotic injury requiring surgery
• Age 18 years or older
• Ability to understand the content of the patient information/Informed consent form

Exclusion Criteria:

• Any not medically managed severe systemic disease
• Patient preference for specific implant
• Refusal of randomization
• Pregnant patients
• Prisoners
• Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arthrex Tightrope; Syndesmosis fixation performed with Arthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.	Device: Arthrex Tightrope; High-tensile strength suture syndesmosis repair
Experimental: Synthes Fibulink; Syndesmosis fixation performed with Synthes Fibulink device. This is a high-tension suture fixation with a screw based anchor system.	Device: Synthes Fibulink; High-tensile strength suture syndesmosis repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) pain score	VAS pain score is rated from 0-10 with 0 being no pain and 10 being the worst pain possible.	1 year
Foot and Ankle Disability Index	Functional score with a score of 0-104 with higher scores indicating better function.	1 year
Olerud-Molander Ankle Score	Functional score with a score of 0-100 with higher scores indicating better function	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with medical or surgical complications	Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion	1 year

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Investigators: Principal Investigator: Benjamin Wheatley, NMCSD

Publications and helpful links

General Publications

• Lindsjo U. Operative treatment of ankle fractures. Acta Orthop Scand Suppl. 1981;189:1-131. doi: 10.3109/ort.1981.52.suppl-189.01.
• Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures--an increasing problem? Acta Orthop Scand. 1998 Feb;69(1):43-7. doi: 10.3109/17453679809002355.
• Sagi HC, Shah AR, Sanders RW. The functional consequence of syndesmotic joint malreduction at a minimum 2-year follow-up. J Orthop Trauma. 2012 Jul;26(7):439-43. doi: 10.1097/BOT.0b013e31822a526a.
• Ray R, Koohnejad N, Clement ND, Keenan GF. Ankle fractures with syndesmotic stabilisation are associated with a high rate of secondary osteoarthritis. Foot Ankle Surg. 2019 Apr;25(2):180-185. doi: 10.1016/j.fas.2017.10.005. Epub 2017 Oct 28.
• 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 May;39(5):242-6.
• Gardner MJ, Demetrakopoulos D, Briggs SM, Helfet DL, Lorich DG. Malreduction of the tibiofibular syndesmosis in ankle fractures. Foot Ankle Int. 2006 Oct;27(10):788-92. doi: 10.1177/107110070602701005.
• 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 May;29(5):216-23. doi: 10.1097/BOT.0000000000000245.
• Naqvi GA, Cunningham P, Lynch B, Galvin R, Awan N. Fixation of ankle syndesmotic injuries: comparison of tightrope fixation and syndesmotic screw fixation for accuracy of syndesmotic reduction. Am J Sports Med. 2012 Dec;40(12):2828-35. doi: 10.1177/0363546512461480. Epub 2012 Oct 10.
• Raeder BW, Figved W, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR. Better outcome for suture button compared with single syndesmotic screw for syndesmosis injury: five-year results of a randomized controlled trial. Bone Joint J. 2020 Feb;102-B(2):212-219. doi: 10.1302/0301-620X.102B2.BJJ-2019-0692.R2.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: clinical outcomes; ankle fracture; syndesmosis
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Ankle Injuries
• Other Study ID Numbers: 21-14036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes