Early vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmosis Disruption
Running, not enrolling · Not applicable
Conditions studied: Unstable Ankle Fractures With Syndesmotic Disruption
In brief
No study has prospectively compared a traditional post-operative non-weightbearing protocol versus early post-operative weightbearing as tolerated for unstable ankle injuries after surgical fixation of the syndesmosis. This prospective study will attempt to determine if early weightbearing can improve functional outcomes, result in a quicker return to work, and monitor differences in rates of adverse events. It will exclude the most severe ankle injuries and patients with excluding comorbidities.
Key facts
- Study ID
- NCT05587842
- Run by
- University of Arizona
- People needed
- 150
- Starts
- 2021-02-10
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Unilateral ankle injury with unstable syndesmotic rupture, in the setting of isolated syndesmotic sprain, fibular fracture, bimalleolar, or trimalleolar equivalent ankle fracture
- Surgical fixation of syndesmosis and/or ankle within two weeks of injury
- Closed or low grade open (Gustilo-Anderson grade I \& II low-energy injuries without gross contamination) fractures
- Skeletally mature patients with closed physis
You may not qualify if…
- Previous ipsilateral ankle surgery
- Bilateral ankle fractures or concurrent other lower extremity injuries/major injuries that would affect recovery time
- Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient, developmental delay, etc.)
- Non-ambulatory pre-injury
- Tibial plafond fractures including articular impaction requiring elevation
- Peripheral neuropathy
- BMI over 45
Where it is running
- Banner - University Medical Center, Phoenix campus — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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