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Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
Sponsor: Maastricht University Medical Center
Summary
The goal of the proposed study is to define the optimal rehabilitation for trauma patients with Displaced Intra-articular Calcaneal Fractures, either Permissive Weight Bearing (PWB) or Restricted Weight Bearing (RWB) regarding functional outcomes, health related quality of life, radiographical differences, cost-effectiveness and complications.
Official title: (Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 67 Years
Study Type
INTERVENTIONAL
Enrollment
115
Start Date
2024-07-01
Completion Date
2026-01-01
Last Updated
2024-10-17
Healthy Volunteers
No
Conditions
Interventions
Permissive Weight Bearing group
The Permissive Weight Bearing (PWB) protocol allows earlier post-operative permissive weight bearing, where progression of weight bearing is guided by the subjective experience (for example: pain, weight bearing tolerance) of the patient and the clinical expertise of the treating physician and therapist. Patients allocated to the PWB protocol start weight bearing after wound healing is achieved (approximately two weeks after the operation). Consequently, patients are stimulated to bear as much weight as tolerated by pain and comfort. Treatment will take place according to the PROMETHEUS protocol (treatment- and evaluation protocol). The protocol contains a number of weight bearing milestones (e.g. walking with two crutches, walking with two canes, walking with one cane and walking without any walking aids). The treating physiotherapist or physician records the dates that these milestones are reached in the study database.
Restricted Weight Bearing group
The Restrictive Weight Bearing (RWB) protocol consists of 8 to 12 weeks of postoperative restricted weight (0-10%) bearing, following the current AO Guidelines (7). After 8 weeks of restricted weight bearing, the weight bearing will be increased with 25% per week for 4 weeks. Every time the patient and the treating physical therapist or physician have contact, the weight bearing advice given to the patient at that point in time is recorded (unloaded; partial weight bearing + clarification; full weight bearing). Also, any additional advice given to the patient is recorded.
Locations (11)
Amsterdam University Medical Center
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Amphia Hospital
Breda, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Groene Hart Hospital
Gouda, Netherlands
Maastricht University Medical Center +
Maastricht, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Zuyderland Medical Center
Sittard, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
Elisabeth-Twee Steden Hospital
Tilburg, Netherlands