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

NCT05626036 | Recruiting FDA Device

• 1 other identifier: 21-14036
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Syndesmotic Injuries

Keywords

syndesmosis; clinical outcomes; ankle fracture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of participants with medical or surgical complications

  1 year

Study Arms (2)

Arthrex Tightrope

ACTIVE COMPARATOR

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

Device: Arthrex Tightrope

Synthes Fibulink

EXPERIMENTAL

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

Device: Synthes Fibulink

Interventions

Arthrex Tightrope DEVICE

High-tensile strength suture syndesmosis repair

Arthrex Tightrope

Synthes Fibulink DEVICE

High-tensile strength suture syndesmosis repair

Synthes Fibulink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

Related Publications (9)

• Lindsjo U. Operative treatment of ankle fractures. Acta Orthop Scand Suppl. 1981;189:1-131. doi: 10.3109/ort.1981.52.suppl-189.01.

  PMID: 6787831 RESULT

• 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.

  PMID: 9524517 RESULT

• 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.

  PMID: 22357084 RESULT

• 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.

  PMID: 29409288 RESULT

• 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.

  PMID: 20567742 RESULT

• 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.

  PMID: 17054878 RESULT

• 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.

  PMID: 25260059 RESULT

• 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.

  PMID: 23051785 RESULT

• 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.

  PMID: 32009435 RESULT

MeSH Terms

Conditions

Ankle Injuries; Ankle Fractures

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Benjamin Wheatley

  NMCSD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Hughey

CONTACT

619-532-9535; ashley.e.hughey.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 23, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)