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

University of California, San Francisco332 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

332

Conditions

Femoral Fractures

Interventions

Intramedullary NailingPROCEDURE

Surgical treatment that includes closed or open reduction and stabilization of the femur fracture with an intramedullary rod inserted using antegrade or retrograde technique

Open Reduction Internal FixationPROCEDURE

Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Muhimbili Orthopaedic Institute

Dar es Salaam, Tanzania

Outcomes

Primary Outcomes

Reoperation

Reoperation involving the affected femur for any reason within the first year will be considered an event.

Time frame: 1-year

Secondary Outcomes

Health-related quality of life

Health-related quality of life as measured by the EQ-5D-3L (Swahili version) by the Euroqol Group

Time frame: 1-year

Return to work

Time from surgery to return to work among patients employed at the time of injury

Time frame: 1-year

Clinical union

Defined as full painless weight bearing on the affected extremity

Time frame: 1-year

Radiographic Union

Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score

Time frame: 1-year

Data from ClinicalTrials.gov

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