Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
Recruiting now · Not applicable
Conditions studied: Calcaneus Fracture, Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), Trauma Injury
In brief
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.
Key facts
- Study ID
- NCT05721378
- Run by
- Maastricht University Medical Center
- People needed
- 115
- Starts
- 2024-07-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2024-10-17
Who can join
Age: 18 and older, up to 67. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Maastricht University Medical Center + — Maastricht, Netherlands (enrolling)
- Radboud University Medical Center — Nijmegen, Netherlands (enrolling)
- Amphia Hospital — Breda, Netherlands
- Catharina Hospital — Eindhoven, Netherlands
- Groene Hart Hospital — Gouda, Netherlands
- Maasstad Hospital — Rotterdam, Netherlands
- Zuyderland Medical Center — Sittard, Netherlands
- Haaglanden Medical Center — The Hague, Netherlands
- Amsterdam University Medical Center — Amsterdam, Netherlands
- Elisabeth-Twee Steden Hospital — Tilburg, Netherlands
- Rijnstate Hospital — Arnhem, Netherlands
Full record on ClinicalTrials.gov
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