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RECRUITING
NCT05721378
NA

Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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