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

Completed

• Conditions: Femoral Fractures
• Interventions: Procedure: Intramedullary Nailing; Procedure: Open Reduction Internal Fixation

• Registration Number: NCT01548456
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Study Start: 2012-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-16
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intramedullary nailing	Intramedullary Nailing	Subjects with a femur fracture who undergo operative fixation with an intramedullary nail
Open Reduction Internal Fixation	Open Reduction Internal Fixation	Subjects with a femur fracture who undergo open reduction internal fixation with a dynamic compression plate

Primary Outcome Measures

Name	Time	Method
Reoperation	1-year	Reoperation involving the affected femur for any reason within the first year will be considered an event.

Secondary Outcome Measures

Name	Time	Method
Clinical union	1-year	Defined as full painless weight bearing on the affected extremity
Health-related quality of life	1-year	Health-related quality of life as measured by the EQ-5D-3L (Swahili version) by the Euroqol Group
Return to work	1-year	Time from surgery to return to work among patients employed at the time of injury
Radiographic Union	1-year	Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score

Trial Locations

Locations (1)

Muhimbili Orthopaedic Institute; 🇹🇿 Dar es Salaam, Tanzania