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NCT05721378
Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
Conditions: Calcaneus Fracture, Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), Trauma Injury
Sex: All
Ages: 18 Years – 67 Years
Phase: NA
Enrollment: 60
Sponsor: Maastricht University Medical Center
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 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 instructionsIndication for open/closed reduction and internal fixationWritten Informed ConsentExclusion 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 extremitiesUnable 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 extremityPre-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 extremitiesSevere psychiatric comorbidities that lead to inability to comply with the treatment protocolPathologic fractures (metastasis, secondary osteoporosis)Peripheral neuropathy and/or diabetesAlcohol- or drug abuse preventing adequate follow-upPrimary indication for arthrodesis subtalar jointTwo or more fractures of the upper and/or lower extremities
Source: ClinicalTrials.gov (NCT05721378). StuddyBuddy aggregates publicly available trial information.