Comparing two methods for treating ankle syndesmosis injuries
Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
This study tests whether using screws or sutures for surgery can help adults with ankle syndesmosis injuries recover better and walk normally after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 3 sites (Bellevue, Nebraska and 2 other locations) |
| Trial ID | NCT04972578 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of two surgical techniques, screw fixation and suture fixation, for treating acute syndesmosis injuries in the ankle. It is a prospective randomized trial involving adults with isolated rotational ankle injuries and syndesmotic instability. Participants will be randomly assigned to one of the two treatment groups and followed for one year to assess clinical outcomes and patient-reported outcomes. Additionally, the study will objectively measure and compare postoperative gait patterns between the two groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with isolated rotational ankle injuries and confirmed syndesmotic instability.
Not a fit: Patients with open fractures, length-unstable fracture patterns, or those who are non-ambulatory will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the optimal surgical technique for improving recovery and functional outcomes in patients with syndesmosis injuries.
How similar studies have performed: While there is ongoing debate regarding the superiority of screw versus suture fixation, this study aims to fill a gap in the literature by providing objective gait outcome comparisons, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 19 years of age and older. * Isolated rotational ankle injury * Syndesmotic instability (determined either pre- or intra-operatively) * Length-stable fibula fracture pattern Exclusion Criteria: * Open fracture * Length-unstable fracture pattern (including Maisonneuve fracture pattern) * Syndesmotic stability (determined either pre- or intra-operatively) * Lower extremity neuropathy * History of prior trauma or surgery to injured ankle * Non-ambulatory patient * Baseline use of ambulatory assistive device prior to injury
Where this trial is running
Bellevue, Nebraska and 2 other locations
- Nebraska Medicine, Bellevue Health Center — Bellevue, Nebraska, United States (Recruiting)
- Lauritzen Outpatient Center — Omaha, Nebraska, United States (Recruiting)
- Village Point Outpatient Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Sarah M Putnam, MD — University of Nebraska
- Study coordinator: Sarah M Putnam, MD
- Email: sara.putnam@unmc.edu
- Phone: 402-559-8519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.