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

Primary Purpose

Syndesmotic Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthrex Tightrope
Synthes Fibulink
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syndesmotic Injuries focused on measuring syndesmosis, clinical outcomes, ankle fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Naval Medical Center San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthrex Tightrope

Synthes Fibulink

Arm Description

Syndesmosis fixation performed with Arthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.

Syndesmosis fixation performed with Synthes Fibulink device. This is a high-tension suture fixation with a screw based anchor system.

Outcomes

Primary Outcome Measures

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.
Foot and Ankle Disability Index
Functional score with a score of 0-104 with higher scores indicating better function.
Olerud-Molander Ankle Score
Functional score with a score of 0-100 with higher scores indicating better function

Secondary Outcome Measures

Number of participants with medical or surgical complications
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion

Full Information

First Posted
October 12, 2022
Last Updated
November 22, 2022
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05626036
Brief Title
Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Official Title
Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syndesmotic Injuries
Keywords
syndesmosis, clinical outcomes, ankle fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthrex Tightrope
Arm Type
Active Comparator
Arm Description
Syndesmosis fixation performed with Arthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
Arm Title
Synthes Fibulink
Arm Type
Experimental
Arm Description
Syndesmosis fixation performed with Synthes Fibulink device. This is a high-tension suture fixation with a screw based anchor system.
Intervention Type
Device
Intervention Name(s)
Arthrex Tightrope
Intervention Description
High-tensile strength suture syndesmosis repair
Intervention Type
Device
Intervention Name(s)
Synthes Fibulink
Intervention Description
High-tensile strength suture syndesmosis repair
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) pain score
Description
VAS pain score is rated from 0-10 with 0 being no pain and 10 being the worst pain possible.
Time Frame
1 year
Title
Foot and Ankle Disability Index
Description
Functional score with a score of 0-104 with higher scores indicating better function.
Time Frame
1 year
Title
Olerud-Molander Ankle Score
Description
Functional score with a score of 0-100 with higher scores indicating better function
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants with medical or surgical complications
Description
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Hughey
Phone
619-532-9535
Email
ashley.e.hughey.ctr@health.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Wheatley
Organizational Affiliation
NMCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Hughey
First Name & Middle Initial & Last Name & Degree
Benjamin Wheatley

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6787831
Citation
Lindsjo U. Operative treatment of ankle fractures. Acta Orthop Scand Suppl. 1981;189:1-131. doi: 10.3109/ort.1981.52.suppl-189.01.
Results Reference
result
PubMed Identifier
9524517
Citation
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.
Results Reference
result
PubMed Identifier
22357084
Citation
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.
Results Reference
result
PubMed Identifier
29409288
Citation
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.
Results Reference
result
PubMed Identifier
20567742
Citation
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.
Results Reference
result
PubMed Identifier
17054878
Citation
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.
Results Reference
result
PubMed Identifier
25260059
Citation
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.
Results Reference
result
PubMed Identifier
23051785
Citation
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.
Results Reference
result
PubMed Identifier
32009435
Citation
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.
Results Reference
result

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

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