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

NCT ID: NCT03377205

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2026-01-31

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.

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plate

Compression screws and neutralization plate.

Group Type: ACTIVE_COMPARATOR

Compression screws and neutralization plate

Intervention Type: DEVICE

Open reduction and internal fixation with screws and plate

Intramedullary nail

Acumed Fibular Rod System

Group Type: EXPERIMENTAL

Acumed Fibular Rod System

Intervention Type: DEVICE

intramedullary nailing of fibula

Interventions

Compression screws and neutralization plate

Open reduction and internal fixation with screws and plate

Intervention Type: DEVICE

Acumed Fibular Rod System

intramedullary nailing of fibula

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Ellingsen Husebye

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth E Husebye, MD, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2016/137 (REK)

Identifier Type: -

Identifier Source: org_study_id