Actively Recruiting
Comparing Immediate and Delayed Weight-bearing After Surgery for Lateral Malleolus Fractures
Led by Ente Ospedaliero Cantonale, Bellinzona · Updated on 2025-08-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two rehabilitation methods for patients who have had surgery to treat malleolar fractures, specifically focusing on immediate complete weight-bearing versus delayed weight-bearing. The study targets patients with more stable lateral malleolar fractures, classified as Weber A and Weber B, to safely evaluate if immediate weight-bearing can speed up ankle functional recovery without increasing complications. This randomized controlled trial plans to enroll about 100 patients to detect meaningful differences in recovery scores six weeks after surgery. After surgery, patients will be assigned to one of two groups. The experimental group will begin full weight-bearing immediately, performing daily activities without limits or walking aids while wearing an ankle brace for protection. The control group will delay full weight-bearing for six weeks, limiting weight on the ankle to 20-30% of their body weight using crutches, also with an ankle brace. Follow-up visits occur at 2, 6, 12, and 24 weeks post-surgery, with extended monitoring up to 48 weeks if fracture healing is delayed. Participants will undergo clinical assessments including subjective and objective ankle function, pain levels, quality of life, and radiological evaluations at scheduled visits. Researchers will measure changes in functional recovery using the Olerud-Molander Ankle Score primarily at six weeks. Safety will be monitored throughout, and patient satisfaction will be recorded. The study duration is approximately two and a half years, covering enrollment and follow-up periods.
CONDITIONS
Brief Title
A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults
- Age ranging from 18 to 70 years, included
- Signed Informed Consent
- Ankle fracture requiring surgical management classified as Weber A or Weber B fracture pattern, with or without associated medial or posterior lesion/fracture
- Willingness and ability to participate in the trial
You will not qualify if you...
- Weber C fracture pattern
- Bilateral fractures or fractures in other locations
- Maisonneuve associated lesion
- Body Mass Index less than 18.5 or greater than or equal to 30
- Metabolic diseases influencing fracture healing
- Medical conditions preventing surgery
- Inability to follow study procedures due to language, psychological, dementia, or physical problems
- Inability or contraindications to undergo the study intervention
- Other significant diseases such as renal failure, liver dysfunction, cardiovascular disease
- Pregnant women
Research Team
E
Enrique Adrian Testa, MD
C
Christian Candrian, MD, Prof
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