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

Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Femoral Fractures
• Intervention / Treatment: Procedure: Intramedullary Nailing; Procedure: Open Reduction Internal Fixation

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 Type: Observational
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Muhimbili Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with diaphyseal fractures of the femur presenting to Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania will be considered eligible for enrollment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intramedullary nailing; Subjects with a femur fracture who undergo operative fixation with an intramedullary nail	Procedure: 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; Other Names: SIGN Intramedullary Nail
Open Reduction Internal Fixation; Subjects with a femur fracture who undergo open reduction internal fixation with a dynamic compression plate	Procedure: Open Reduction Internal Fixation; Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation	Reoperation involving the affected femur for any reason within the first year will be considered an event.	1-year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Orthopaedic Trauma Association; Muhimbili Orthopaedic Institute; Orthopaedic Research Foundation
• Investigators: Principal Investigator: David W Shearer, MD, MPH, University of California, San Francisco; Study Director: Edmund N Eliezer, MD, Muhimbili Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 16, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: femur fracture; internal fixation; intramedullary nailing
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: UCSF 23346