Status:
ACTIVE_NOT_RECRUITING
Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Ostfold Hospital Trust
Vestre Viken Hospital Trust
Conditions:
Ankle Fractures
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elde...
Detailed Description
Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidit...
Eligibility Criteria
Inclusion
- Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).
- Operable with both methods of surgery within 3 weeks after injury.
- Men and women ≥ 60 yoa.
Exclusion
- Prior injury or pathology with reduced ankle function.
- Other acute foot/ankle/leg injury that will affect ankle function.
- Fracture of the posterior malleolus that need fixation.
- Injury / pathology that may affect rehabilitation.
- Open fracture.
- Inoperable patient.
- Dementia (MMSE score ≤ 24 points), reduced competent to consent, not able to express himself/herself in Norwegian or English.
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03377205
Start Date
June 1 2016
End Date
January 1 2026
Last Update
July 13 2023
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0450