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

Femoral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548456
• Other study ID #: UCSF 23346
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: May 16, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

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
• Open Reduction Internal Fixation
Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate

Locations

Country	Name	City	State
Tanzania	Muhimbili Orthopaedic Institute	Dar es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Muhimbili Orthopaedic Institute, Orthopaedic Research Foundation, Orthopaedic Trauma Association

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Reoperation involving the affected femur for any reason within the first year will be considered an event.	1-year	Yes
Secondary	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	No
Secondary	Return to work	Time from surgery to return to work among patients employed at the time of injury	1-year	No
Secondary	Clinical union	Defined as full painless weight bearing on the affected extremity	1-year	No
Secondary	Radiographic Union	Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score	1-year	No