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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Femoral Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intramedullary nailing

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

Intramedullary Nailing

Intervention Type PROCEDURE

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 Fixation

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

Open Reduction Internal Fixation

Intervention Type PROCEDURE

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

Interventions

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Intramedullary Nailing

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

Intervention Type PROCEDURE

Open Reduction Internal Fixation

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

Intervention Type PROCEDURE

Other Intervention Names

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SIGN Intramedullary Nail

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No