Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

NCT05721378 | Recruiting DMC

• 1 other identifier: PIONEER
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Keywords

Permissive Weight Bearing; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in functional outcome as defined by the AOFAS questionnaire

  The American Orthopaedic Foot \& Ankle Society (AOFAS) score is a clinician-based score. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. It is designed for physicians to help standardize the assessment of patients and makes the results of this study comparable with previous data. Scores range from 0 to 100, with healthy foot and ankles receiving 100 points.

  0, 2, 6, 12 weeks and 6 months post-surgery.

Secondary Outcomes (7)

• Self-reported function with the Maryland Foot Score

  0, 2, 6, 12 weeks and 6 months post-surgery

• Activities of Daily Living (ADL) with LEFS

  0, 2, 6, 12 weeks and 6 months post-surgery

• Health Related Quality of Life with EQ-5D-5L

  0, 2, 6, 12 weeks and 6 months post-surgery

• Böhlers angle and posterior facet joint

  Early postoperative (before first mobilization) and 6 months post-surgery

• Medical consumption with iMCQ

  0 weeks and 6 months post-surgery

Study Arms (2)

Permissive Weight Bearing group

EXPERIMENTAL

Rehabilitation following the Permissive Weight Bearing (PWB) protocol

Procedure: Permissive Weight Bearing group

Restrictive Weight Bearing group

ACTIVE COMPARATOR

Rehabilitation following the Restrictive Weight Bearing (RWB) protocol

Procedure: Restricted Weight Bearing group

Interventions

Permissive Weight Bearing group 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.

Also known as: Early Weight Bearing

Permissive Weight Bearing group

Restricted Weight Bearing group 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.

Also known as: Non Weight Bearing

Restrictive Weight Bearing group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (11)

Amsterdam University Medical Center

Amsterdam, Netherlands

NOT YET RECRUITING

Rijnstate Hospital

Arnhem, Netherlands

NOT YET RECRUITING

Amphia Hospital

Breda, Netherlands

NOT YET RECRUITING

Catharina Hospital

Eindhoven, Netherlands

NOT YET RECRUITING

Groene Hart Hospital

Gouda, Netherlands

NOT YET RECRUITING

Maastricht University Medical Center +

Maastricht, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

RECRUITING

Maasstad Hospital

Rotterdam, Netherlands

NOT YET RECRUITING

Zuyderland Medical Center

Sittard, Netherlands

NOT YET RECRUITING

Haaglanden Medical Center

The Hague, Netherlands

NOT YET RECRUITING

Elisabeth-Twee Steden Hospital

Tilburg, Netherlands

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 39558368 DERIVED

MeSH Terms

Conditions

Disease; Accidental Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Coen Verstappen, MD

CONTACT

+31(0)43-3877489; coen.verstappen@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 10, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (11)