Early vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmos… (NCT05587842) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmosis Disruption
United States150 participantsStarted 2021-02-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.