Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Ankle Fractures

Treatments: Device: Acumed Fibular Rod System; Device: Compression screws and neutralization plate

Study type: Interventional

Funder types: Other

Identifiers

NCT03377205

2016/137 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Plate

Active Comparator group

Description:

Compression screws and neutralization plate.

Treatment:

Device: Compression screws and neutralization plate

Intramedullary nail

Experimental group

Description:

Acumed Fibular Rod System

Treatment:

Device: Acumed Fibular Rod System