BridgeMD
New treatment option for Calcaneus Fracture
Official title Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
ClinicalTrials.gov ID: NCT05721378
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 67
You may be able to join 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 likely can't join 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Arnhem, Netherlands
- Breda, Netherlands
- Eindhoven, Netherlands
- Gouda, Netherlands
- Maastricht, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Sittard, Netherlands
- The Hague, Netherlands
- Tilburg, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 67 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Arnhem, Netherlands; Breda, Netherlands; Eindhoven, Netherlands; Gouda, Netherlands; Maastricht, Netherlands and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.