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| Name | Class |
|---|---|
| Ostfold Hospital Trust | OTHER |
| Vestre Viken Hospital Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plate | Active Comparator | Compression screws and neutralization plate. |
|
| Intramedullary nail | Experimental | Acumed Fibular Rod System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression screws and neutralization plate | Device | Open reduction and internal fixation with screws and plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Orthopaedic Foot and Ankle Society (AOFAS) score | Functional outcome as assessed by AOFAS score (0-100) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Manchester-Oxford Foot questionnaire (MOxFQ) | Patient reported outcome as assessed by MOxFQ (0-100) | 5 years |
| Olerud and Molander Score (OMS) | Patient reported outcome as assessed by OMS (0-100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth E Husebye, MD, PhD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0450 | Norway |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| Acumed Fibular Rod System | Device | intramedullary nailing of fibula |
|
| 5 years |
| EuroQol-5d (Eq-5d) | Patient reported quality of life as assessed by Eq-5d index score | 5 years |
| Visual analogue scale (VAS) | 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 | 5 years |
| Fracture reduction as assessed by CT scans | Number of patients with good, fair or poor fracture reduction | 3 months |
| Malunion as assessed by CT scans | Number of patients with malunion | 5 years |
| Nonunion as assessed by CT scans | Number of patients with nonunion | 5 years |
| Osteoarthritis as assessed by CT scans | Number of patients with osteoarthritis assessed according to the criteria by McLennan et al | 5 years |
| Infection | Number of patients with wound infection or deep infection | 3 months |
| Delayed wound healing | Number of patients with delayed wound healing | 3 months |
| Other complications | Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation) | 5 years |