NCT03377205

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

Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
DEVICE	Compression screws and neutralization plate	Open reduction and internal fixation with screws and plate
DEVICE	Acumed Fibular Rod System	intramedullary nailing of fibula

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-06-01
• Completion: 2026-01-01
• First posted: 2017-12-19
• Last updated: 2023-07-13

Locations

1 site across 1 country: Norway