Comparing immediate and delayed weight-bearing after ankle surgery
Official title: Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial
Run by Ente Ospedaliero Cantonale, Bellinzona · NCT04429217 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Status | Recruiting |
| Started | April 28, 2020 |
| Main results expected | February 2, 2028 |
| Study ends | February 2, 2028 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT04429217 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 70 with stable Weber A or B lateral malleolus fractures requiring surgical intervention.
✕Probably not a fit
Patients with Weber C fractures, bilateral fractures, or significant medical comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with immediate weight-bearing protocols in similar fracture types, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Quality of life after open repair for complex abdominal aortic aneurysms
This project will use the SF-36 questionnaire to see how open surgical repair affects quality of life over one year in adults having open surgery for complex abdominal aortic aneurysms.
-
Music to reduce stress during wound dressing
The team will try playing music chosen by hospitalized adults during wound dressing to see if it reduces stress and improves the experience.
-
Using virtual reality to reduce the need for preoperative sedative medication
This trial will try virtual reality to see if it reduces the need for sedative premedication in adults who request medication before elective surgery.
-
Fixing a broken elbow with a metal plate versus non-surgical care in older adults
This test sees if using a metal plate to fix a displaced olecranon fracture helps older adults with low arm demands recover better and regain arm function than non-surgical treatment.
-
Pudendal nerve block versus sacral erector spinae (ESP) block for pain after hemorrhoidectomy
This will test whether the sacral erector spinae (ESP) block gives equal or better pain relief than the pudendal nerve block for adults having elective hemorrhoid surgery.
-
Video vs in-person preoperative anesthesia visit for children having tonsil and adenoid removal
We will test whether doing the anesthesiology visit by video works as well as an in-person visit at preventing breathing problems during and in the first 24 hours after tonsil/adenoid removal in children.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.