Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.
- Conditions
- Ankle Fractures
- Interventions
- Device: Compression screws and neutralization plateDevice: Acumed Fibular Rod System
- Registration Number
- NCT03377205
- Lead Sponsor
- Oslo University Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Plate Compression screws and neutralization plate Compression screws and neutralization plate. Intramedullary nail Acumed Fibular Rod System Acumed Fibular Rod System
- Primary Outcome Measures
Name Time Method American Orthopaedic Foot and Ankle Society (AOFAS) score 5 years Functional outcome as assessed by AOFAS score (0-100)
- Secondary Outcome Measures
Name Time Method Delayed wound healing 3 months Number of patients with delayed wound healing
Olerud and Molander Score (OMS) 5 years Patient reported outcome as assessed by OMS (0-100)
Visual analogue scale (VAS) 5 years VAS scores for pain during rest (0-10), during walking (0-10), at night (0-10), and during daily activities (0-10), where 10 is best
Infection 3 months Number of patients with wound infection or deep infection
Malunion as assessed by CT scans 5 years Number of patients with malunion
Nonunion as assessed by CT scans 5 years Number of patients with nonunion
Manchester-Oxford Foot questionnaire (MOxFQ) 5 years Patient reported outcome as assessed by MOxFQ (0-100)
EuroQol-5d (Eq-5d) 5 years Patient reported quality of life as assessed by Eq-5d index score
Osteoarthritis as assessed by CT scans 5 years Number of patients with osteoarthritis assessed according to the criteria by McLennan et al
Fracture reduction as assessed by CT scans 3 months Number of patients with good, fair or poor fracture reduction
Other complications 5 years Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway