Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Any not medically managed severe systemic disease

Patient preference for specific implant

Refusal of randomization

Pregnant patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arthrex Tightrope

    Device

    High-tensile strength suture syndesmosis repair

  • Synthes Fibulink

    Device

    High-tensile strength suture syndesmosis repair

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Arthrex TightropeActive comparator 1 intervention
Group B: Synthes FibulinkExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale (VAS) Pain score

VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain

Time frame
1 year
2

Foot and Ankle Disability Index

Functional score with a 0-104 with higher scores indicating better function

Time frame
1 year
3

Olerud-Molander Ankle Score

Functional Score with a score of 0-100 with higher scores indicating better function

Time frame
1 year

Secondary outcomes

1

Number of participants with medical or surgical complications

Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion

Time frame
1 year

Other outcomes

Sponsors and contacts

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