Comparing weight bearing protocols for healing calcaneal fractures
(Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
NA · Maastricht University Medical Center · NCT05721378
This study is testing two different ways of putting weight on your foot after surgery for a broken heel bone to see which one helps you heal better and feel good over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 67 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 11 sites (Amsterdam and 10 other locations) |
| Trial ID | NCT05721378 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the optimal rehabilitation approach for patients with Displaced Intra-articular Calcaneal Fractures by comparing two protocols: Permissive Weight Bearing (PWB) and Restricted Weight Bearing (RWB). It will assess functional outcomes, health-related quality of life, radiographical differences, cost-effectiveness, and complications over a 12-week period. The study is designed as a multi-center randomized controlled trial involving surgically treated patients who meet specific eligibility criteria. The primary outcome will be measured using the American Orthopaedic Foot & Ankle Society (AOFAS) Score.
Who should consider this trial
Good fit: Ideal candidates are surgically treated trauma patients aged 18 to 67 with isolated unilateral Displaced Intra-articular Calcaneal Fractures.
Not a fit: Patients with acute or existing amputations, open calcaneal fractures, or severe comorbidities affecting mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that enhance recovery and quality of life for patients with calcaneal fractures.
How similar studies have performed: While there is limited evidence on the optimal rehabilitation protocols for this specific fracture type, similar studies have shown varying success with different weight-bearing approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 10 other locations
- 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)
Study contacts
- Study coordinator: Coen Verstappen, MD
- Email: coen.verstappen@mumc.nl
- Phone: +31(0)43-3877489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Calcaneus Fracture, Displaced Intra-Articular Fracture of Calcaneus, Trauma Injury, Permissive Weight Bearing, Rehabilitation