Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania

University of California San Francisco (UCSF)

Status: Completed

Conditions: Femoral Fractures

Treatments: Procedure: Open Reduction Internal Fixation; Procedure: Intramedullary Nailing

Study type: Observational

Funder types: Other

Identifiers

NCT01548456

UCSF 23346

Details and patient eligibility

About

This is a prospective observational study of patients with femur fractures in Dar es Salaam, Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of reoperation for any reason, and the secondary outcomes are fracture healing, return to work, and health-related quality-of-life. The investigators hypothesize that there will be a difference in the rate of reoperation for patients with femur fractures treated with an IMN compared to ORIF with a plate.

Full description

The study will be a prospective clinical trial conducted at Muhimbili Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. All adult patients with diaphyseal femur fractures meeting the eligibility criteria will be invited to enroll. Study subjects will be treated at the discretion of the surgeons at MOI. This could include an intramedullary nail, a plate, external fixation, or skeletal traction. Potential confounders recorded will be age, gender, body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury to presentation, time from presentation to surgery, and associated injuries. The primary outcome considered will be reoperation for any reason. Secondary outcomes will be clinical union, defined as full-painless weight bearing on the injured extremity, radiographic union, return to work, and health-related quality-of-life. Follow up will be scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and radiographic evaluation.

Enrollment: 332 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate
2. Age 18 to 65

Exclusion criteria

1. Clinical evidence of infection at the surgical site (defined clinically as drainage or erythema)
2. Pathologic fracture
3. Prior surgery
4. Presentation 3 weeks or more after injury
5. Inability or unwillingness to comply with follow up to 1-year

Trial design

332 participants in 2 patient groups

Intramedullary nailing

Description:

Subjects with a femur fracture who undergo operative fixation with an intramedullary nail

Treatment:

Procedure: Intramedullary Nailing

Open Reduction Internal Fixation

Description:

Subjects with a femur fracture who undergo open reduction internal fixation with a dynamic compression plate

Treatment:

Procedure: Open Reduction Internal Fixation