Actively Recruiting
Led by Maastricht University Medical Center · Updated on 2024-10-17
115
Participants Needed
11
Research Sites
26 weeks
Total Duration
Researchers are evaluating the best rehabilitation method for patients who have suffered Displaced Intra-articular Calcaneal Fractures (DIACFs), which are fractures involving the heel bone often requiring surgery. This study aims to compare two rehabilitation protocols: Permissive Weight Bearing (PWB) and Restricted Weight Bearing (RWB), focusing on functional outcomes, quality of life, radiographic differences, cost-effectiveness, and complications. The trial is a multi-center randomized controlled study involving patients aged 18 to 67 years who have undergone surgical fixation for DIACFs. Participants are randomly assigned to one of two rehabilitation groups. The PWB group starts weight bearing about two weeks post-surgery after wound healing, progressing according to patient comfort and pain with guidance from therapists and physicians. They follow milestones such as walking with crutches or canes with recordings of progress. The RWB group follows standard AO guidelines with 8 to 12 weeks of minimal weight bearing (0-10%), gradually increasing weight bearing by 25% weekly after 8 weeks. Both protocols include detailed records of weight bearing advice throughout treatment. During the study, participants will be assessed at 0, 2, 6, 12 weeks, and 6 months after surgery. Researchers will measure functional outcomes using the AOFAS questionnaire, foot function scores, daily living activities, quality of life surveys, and radiographic parameters like Böhler's angle. Costs and complications will also be tracked. Follow-up visits align with current trauma guidelines and include clinical evaluations and imaging, with radiation exposure consistent with standard care. The total study duration allows for comprehensive monitoring of recovery and rehabilitation effects.
CONDITIONS
Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive surgical treatment for displaced intra-articular calcaneal fractures followed by rehabilitation according to either the Permissive Weight Bearing or Restricted Weight Bearing protocol.
Visits at 2, 6, and 12 weeks post-surgery
Duration - Up to 6 months post-surgery
Participants are monitored for functional outcomes, complications, and quality of life up to 6 months after surgery.
Visits at 6 months post-surgery
Total: 11 locations
1
Amsterdam University Medical Center
Amsterdam, Netherlands
Not Yet Recruiting
2
Rijnstate Hospital
Arnhem, Netherlands
Not Yet Recruiting
3
Amphia Hospital
Breda, Netherlands
Not Yet Recruiting
4
Catharina Hospital
Eindhoven, Netherlands
Not Yet Recruiting
5
Groene Hart Hospital
Gouda, Netherlands
Not Yet Recruiting
6
Maastricht University Medical Center +
Maastricht, Netherlands
Actively Recruiting
7
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
8
Maasstad Hospital
Rotterdam, Netherlands
Not Yet Recruiting
9
Zuyderland Medical Center
Sittard, Netherlands
Not Yet Recruiting
10
Haaglanden Medical Center
The Hague, Netherlands
Not Yet Recruiting
11
Elisabeth-Twee Steden Hospital
Tilburg, Netherlands
Not Yet Recruiting
C
Coen Verstappen, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Coen Verstappen, Mitchell L S Driessen, Pishtiwan H S Kalmet...
https://pubmed.ncbi.nlm.nih.gov/39558368