Ankle Fractures
Conditions
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.
Interventions
DEVICECompression screws and neutralization plate
Open reduction and internal fixation with screws and plate
DEVICEAcumed Fibular Rod System
intramedullary nailing of fibula
Sponsors
Ostfold Hospital Trust
Vestre Viken Hospital Trust
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Orthopaedic Foot and Ankle Society (AOFAS) score | 5 years | Functional outcome as assessed by AOFAS score (0-100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Olerud and Molander Score (OMS) | 5 years | Patient reported outcome as assessed by OMS (0-100) |
| EuroQol-5d (Eq-5d) | 5 years | Patient reported quality of life as assessed by Eq-5d index score |
| 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 |
| Fracture reduction as assessed by CT scans | 3 months | Number of patients with good, fair or poor fracture reduction |
| Malunion as assessed by CT scans | 5 years | Number of patients with malunion |
| Manchester-Oxford Foot questionnaire (MOxFQ) | 5 years | Patient reported outcome as assessed by MOxFQ (0-100) |
| Osteoarthritis as assessed by CT scans | 5 years | Number of patients with osteoarthritis assessed according to the criteria by McLennan et al |
| Infection | 3 months | Number of patients with wound infection or deep infection |
| Delayed wound healing | 3 months | Number of patients with delayed wound healing |
| Other complications | 5 years | Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation) |
| Nonunion as assessed by CT scans | 5 years | Number of patients with nonunion |
Countries
Norway
Outcome results
None listed