Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
(Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
Maastricht University Medical Center
115 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria14
- 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
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Interventions
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.
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.
Locations(11)
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NCT05721378