NCT05721378

Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

(Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rationale: Of all fractures, 1-2% involve the calcaneus. Often surgical treatment is needed. Even after successful treatment it requires long rehabilitation with major impact on daily life and socio-economic aspects. Anatomic surgical restoration does not prevent gait disturbances or persistent foot pain. An adequate rehabilitation program is mandatory to maximize foot stability. Objective: Evidence showing which rehabilitation protocol is best for both fracture healing and quality of life for patients with Displaced Intra-Articular Calcaneal Fractures (DIACFs) is mostly lacking. This study has the aim to answer the question whether surgically treated patients with DIACFs following the Permissive Weight Bearing protocol (PWB) have better functional outcomes compared to patients with Restricted Weight Bearing protocol after 12 weeks (RWB) measured with the American Orthopaedic Foot \& Ankle Society (AOFAS) Score. The study hypothesizes that patients with DIACFs following the PWB protocol will have a better quality of life (HR-QOL) compared to patients who followed the RWB protocol. The hypothesis is that there will be lower costs without any radiographic differences for surgically treated (irrespective of technique used) patients with DIACFs following a PWB protocol comparing to the current AO (Arbeitsgemeinschaft für Osteosynthesefragen) standard care: the RWB protocol. Study design: Multi-center randomized controlled trial Study population: Presence of surgically (extended lateral, sinus tarsi or percutaneous approach) fixed DIACFs classified as Sanders type II to IV, age 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. Patients will only be included after written informed consent is obtained. Groups (intervention and control): Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB. Main study parameters/endpoints: Primary objective: functional outcome. Secondary outcomes: quality of life, differences in radiographic parameters, complications, cost effectiveness and differences in surgical techniques. Nature and extent of the burden: The PWB protocol aims to restore weight bearing faster than RWB protocol in DIACFs. Early postoperative weight bearing poses the risk of increased complications, such as secondary displacement of the fracture or failure of fracture fixation. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate, although data from prospective randomized trials in calcaneus fractures are lacking. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks and 6 months. The radiation exposure will not be different from standard of care. Therefore, the burden for participants is considered minimal, with no significant health risks.

Conditions

• Calcaneus Fracture
• Displaced Intra-Articular Fracture of Calcaneus (Diagnosis)
• Trauma Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2026-01-01
• First posted: 2023-02-10
• Last updated: 2024-10-17

Locations

11 sites across 1 country: Netherlands