Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
Netherlands115 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 67 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in functional outcome as defined by the AOFAS questionnaire
Timeframe: 0, 2, 6, 12 weeks and 6 months post-surgery.