Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures — PIONEER  

Trauma Injury Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Calcaneus Fracture
• Fractures, Bone
• Intra-Articular Fractures
• Trauma Injury

• NCT number: NCT05721378
• Study type: Interventional
• Source: Maastricht University Medical Center
• Contact: Coen Verstappen, MD
• Phone: +31(0)43-3877489
• Email: coen.verstappen@mumc.nl
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Completion date: July 2025