Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ankle Fractures
- Sponsor
- Oslo University Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- American Orthopaedic Foot and Ankle Society (AOFAS) score
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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 elderly patients, and contribute in choosing the best surgical method for these ankle fractures.
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-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.
Investigators
Elisabeth Ellingsen Husebye
Principal investigator
Oslo University Hospital
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) score
Time Frame: 5 years
Functional outcome as assessed by AOFAS score (0-100)
Secondary Outcomes
- Olerud and Molander Score (OMS)(5 years)
- Visual analogue scale (VAS)(5 years)
- Infection(3 months)
- Malunion as assessed by CT scans(5 years)
- Nonunion as assessed by CT scans(5 years)
- Manchester-Oxford Foot questionnaire (MOxFQ)(5 years)
- EuroQol-5d (Eq-5d)(5 years)
- Osteoarthritis as assessed by CT scans(5 years)
- Fracture reduction as assessed by CT scans(3 months)
- Delayed wound healing(3 months)
- Other complications(5 years)