Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

NCT ID: NCT05721378

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Permissive Weight Bearing group

Rehabilitation following the Permissive Weight Bearing (PWB) protocol

Group Type: EXPERIMENTAL

Permissive Weight Bearing group

Intervention Type: PROCEDURE

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.

Restrictive Weight Bearing group

Rehabilitation following the Restrictive Weight Bearing (RWB) protocol

Group Type: ACTIVE_COMPARATOR

Restricted Weight Bearing group

Intervention Type: PROCEDURE

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.

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Early Weight Bearing; Non Weight Bearing

Eligibility Criteria

Inclusion Criteria

• Surgically treated trauma patients with isolated unilateral DIACFs, less than 6 weeks after trauma, Sanders type II-IV (14)
• Age between 18 and 67 years old (labor force)
• Being able to understand the questionnaires and measurement instructions
• Indication for open/closed reduction and internal fixation
• Written Informed Consent

Exclusion Criteria

• Acute or existing amputation (upper limb, lower limb, feet)
• Open calcaneal fractures (excluding medial wound without compromising surgical approach)
• Bilateral fractures of the lower extremities
• Unable to comply to the PWB protocol due to pre-existing conditions of the arms and legs (e.g. unable to use crotches due to hemiparalysis)
• Severe non-fracture related comorbidity of the lower extremity
• Pre-existent immobility (loss of muscle function of one or both legs)
• Dependent in activities of daily living (e.g. due to dementia, Alzheimer, New York Heart Association class IV angina, heart failure or oxygen-dependent chronic obstructive pulmonary disease)
• Rheumatoid arthritis of the lower extremities
• Severe psychiatric comorbidities that lead to inability to comply with the treatment protocol
• Pathologic fractures (metastasis, secondary osteoporosis)
• Peripheral neuropathy and/or diabetes
• Alcohol- or drug abuse preventing adequate follow-up
• Primary indication for arthrodesis subtalar joint
• Two or more fractures of the upper and/or lower extremities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Amsterdam University Medical Center

Amsterdam, , Netherlands

Site Status: NOT_YET_RECRUITING

Rijnstate Hospital

Arnhem, , Netherlands

Site Status: NOT_YET_RECRUITING

Amphia Hospital

Breda, , Netherlands

Site Status: NOT_YET_RECRUITING

Catharina Hospital

Eindhoven, , Netherlands

Site Status: NOT_YET_RECRUITING

Groene Hart Hospital

Gouda, , Netherlands

Site Status: NOT_YET_RECRUITING

Maastricht University Medical Center +

Maastricht, , Netherlands

Site Status: RECRUITING

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status: RECRUITING

Maasstad Hospital

Rotterdam, , Netherlands

Site Status: NOT_YET_RECRUITING

Zuyderland Medical Center

Sittard, , Netherlands

Site Status: NOT_YET_RECRUITING

Haaglanden Medical Center

The Hague, , Netherlands

Site Status: NOT_YET_RECRUITING

Elisabeth-Twee Steden Hospital

Tilburg, , Netherlands

Site Status: NOT_YET_RECRUITING

Countries

Netherlands

Central Contacts

Coen Verstappen, MD

Role: CONTACT

coen.verstappen@mumc.nl

+31(0)43-3877489

Facility Contacts

Tim Schepers

Role: primary

MD

Albert Pull ter Gunne, MD

Role: primary

Niels Berende, MD

Role: primary

Alexander van der Veen, MD

Role: primary

Jan Siert Reinders, MD

Role: primary

Martijn Poeze, Prof.

Role: primary

Erik Hermans, MD

Role: primary

Kees van der Vlies, MD

Role: primary

Raoul van Vugt, MD

Role: primary

Jochem Hoogendoorn, MD

Role: primary

Hilco Theeuwes, MD

Role: primary

References

Verstappen C, Driessen MLS, Kalmet PHS, Brandts L, Kimman M, Edwards M, Hermans E, Poeze M. Permissive weight bearing versus restrictive weight bearing in surgically treated trauma patients with displaced intra-articular calcaneal fractures (the PIONEER study): study protocol for a multicenter randomized controlled trial. Trials. 2024 Nov 18;25(1):778. doi: 10.1186/s13063-024-08617-5.

Reference Type: DERIVED

PMID: 39558368 (View on PubMed)

Other Identifiers

PIONEER

Identifier Type: -

Identifier Source: org_study_id