Comparing immediate and delayed weight-bearing after ankle surgery
Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial
This study tests whether allowing patients to put weight on their ankle right after surgery helps them recover better than waiting six weeks to do so.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT04429217 on ClinicalTrials.gov |
What this trial studies
This study evaluates two rehabilitation protocols for patients undergoing surgery for lateral malleolus fractures: immediate complete weight-bearing versus delayed weight-bearing for six weeks. The aim is to determine if immediate weight-bearing can enhance functional recovery without increasing complications. The study will involve 100 patients who meet specific eligibility criteria, including adults aged 18 to 70 with stable Weber A or B fractures. Participants will be randomly assigned to one of the two rehabilitation groups following their surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with stable Weber A or B lateral malleolus fractures requiring surgical intervention.
Not a fit: Patients with Weber C fractures, bilateral fractures, or significant medical comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster recovery times and improved functional outcomes for patients after ankle surgery.
How similar studies have performed: Previous studies have shown promising results with immediate weight-bearing protocols in similar fracture types, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female adults * Age ranging from 18 to 70 years, included * Signed Informed Consent * Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion/fracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion/fracture * Willingness and ability to participate in the trial Exclusion Criteria: * Weber C fracture pattern * Bilateral fractures or fractures in other locations * Maissoneauve associated lesion * Body Mass Index \< 18.5 and ≥ 30 * Metabolic diseases influencing fracture healing processes * Medical comorbidities precluding operative intervention * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc. * Inability or contraindications to undergo the investigated intervention * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * Pregnant women
Where this trial is running
Lugano
- Ente Ospedaliero Cantonale — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Enrique Adrian Testa, MD — Eoc
- Study coordinator: Enrique Adrian Testa, MD
- Email: enriqueadrian.testa@eoc.ch
- Phone: +41 (0)91 811 69 31
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.