Actively Recruiting
Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial
Led by Ente Ospedaliero Cantonale, Bellinzona · Updated on 2025-08-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Day of surgery
Participants undergo surgical treatment for malleolar fractures followed by immediate post-operative care including wearing an ankle brace.
1 surgery visit (in-person)
Duration - Up to 6 weeks
Participants follow one of two post-operative rehabilitation protocols: immediate weight-bearing allowing full weight on the ankle right after surgery, or delayed weight-bearing limiting weight to 20-30% with crutches for 6 weeks. All participants wear an ankle brace during rehabilitation.
Follow-up visits at 2 and 6 weeks (in-person)
Duration - From 6 weeks up to 24 weeks after surgery
Participants continue rehabilitation follow-up with clinical assessments including functional recovery, pain, quality of life, and radiological evaluations.
Follow-up visits at 12 and 24 weeks (in-person)
Duration - Up to 24 additional weeks after 24-week visit
Participants with radiologically confirmed fracture non-union at 24 weeks are followed until 48 weeks after surgery for additional assessments.
Additional visits as needed up to 48 weeks (in-person)
Trial Site Locations
Total: 1 location
1
Ente Ospedaliero Cantonale
Lugano, Switzerland, 6900
Actively Recruiting
Research Team
E
Enrique Adrian Testa, MD
C
Christian Candrian, MD, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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