Status:
UNKNOWN
The BFF Study- The Better to Fix or Fuse Study
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Lisfranc Fracture
Arthrodesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the proposed study is to define the optimal treatment for Lisfranc fracture-dislocation, either primary arthrodesis (PA) or open reduction and internal fixation (ORIF), regarding the qualit...
Detailed Description
SUMMARY Rationale: The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture-dislocation trea...
Eligibility Criteria
Inclusion
- Aged ≥18 years
- Acute Lisfranc fracture injury (\< 6 weeks after trauma)
- Displaced or unstable with weight-bearing radiographs
- Independent for activities of daily living (yes/no question)
Exclusion
- Open Lisfranc injury
- Pure ligamentous Lisfranc injury
- Non-displaced and stable with weight-bearing radiographs
- Contra-indications for general or locoregional anesthetic techniques
- Other fractures at the ipsilateral leg
- Pre-existent abnormalities at the Lisfranc complex
- Pre-existent immobility
- Dependent on activities of daily living (due to dementia, Alzheimer, NYHA class IV angina and heart failure, oxygen-dependent COPD)
- Rheumatoid arthritis
- Pathologic fractures (metastasis, secondary osteoporosis)
- Peripheral neuropathy and/or diabetes
- Alcohol- or drug abuse preventing adequate follow-up
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04519242
Start Date
June 25 2020
End Date
June 25 2024
Last Update
June 29 2021
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands