Status:
RECRUITING
Weber B Ankle Fractures With Associated Posterior Malleolus Fracture
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
University Hospital, Akershus
Ullevaal University Hospital
Conditions:
Posterior Malleolus Fractures
Ankle Fractures
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of...
Detailed Description
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. Weber B fractures are the most common type of fracture of the fibula. ...
Eligibility Criteria
Inclusion
- Posterior malleolar (PM) fracture, of Mason \& Molly type 2A/2B, associated with Weber B lateral malleolar fracture, with or without medial malleolar fracture
- Posterior malleoli \>=2 mm displaced (on CT in axial, sagital or coronal plane)
- Patients informed, written consent
- Age 18-65 years
- For inclusion axial CT images are examined
- Measurements are performed 5 millimeters (mm) cranial to the tibia plafond
- Posterior malleolus fractures involving less than 40% of the fibular notch are included.
Exclusion
- Non-compliant patient, i.e.: dementia, alcohol- or substance abuse
- ASA-4 patients
- Known congenital bone decease
- Pathological fractures
- Immunocompromised patients
- Tourists or patients on a short-term work/study permit
- Previous injury or condition of the ipsilateral ankle or ipsilateral lower extremity with a resulting dysfunction
- Poor controlled diabetes
- Patients with known arterial insufficiency
- Open fractures
- Severely traumatized patients (ISS\>16)
- Patient declines to participate in study
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT05413707
Start Date
March 13 2023
End Date
December 31 2030
Last Update
February 29 2024
Active Locations (1)
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1
Haukeland University Hospital, Orthopedic department
Bergen, Vestland, Norway, 5021