Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Femoral Fractures |
Procedure: Intramedullary Nailing Procedure: Open Reduction Internal Fixation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up |
- Reoperation [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]Reoperation involving the affected femur for any reason within the first year will be considered an event.
- Health-related quality of life [ Time Frame: 1-year ] [ Designated as safety issue: No ]Health-related quality of life as measured by the EQ-5D-3L (Swahili version) by the Euroqol Group
- Return to work [ Time Frame: 1-year ] [ Designated as safety issue: No ]Time from surgery to return to work among patients employed at the time of injury
- Clinical union [ Time Frame: 1-year ] [ Designated as safety issue: No ]Defined as full painless weight bearing on the affected extremity
- Radiographic Union [ Time Frame: 1-year ] [ Designated as safety issue: No ]Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score
| Estimated Enrollment: | 333 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients with diaphyseal fractures of the femur presenting to Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania will be considered eligible for enrollment.
Inclusion Criteria:
- Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate
- Age 18 to 65
Exclusion Criteria:
- Clinical evidence of infection at the surgical site (defined clinically as drainage or erythema)
- Pathologic fracture
- Prior surgery
- Presentation 3 weeks or more after injury
- Inability or unwillingness to comply with follow up to 1-year
Contacts and Locations| Tanzania | |
| Muhimbili Orthopaedic Institute | |
| Dar es Salaam, Tanzania | |
| Principal Investigator: | David W Shearer, MD, MPH | University of California, San Francisco |
| Study Director: | Edmund N Eliezer, MD | Muhimbili Orthopaedic Institute |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01548456 History of Changes |
| Other Study ID Numbers: | UCSF 23346 |
| Study First Received: | February 27, 2012 |
| Last Updated: | October 14, 2012 |
| Health Authority: | Tanzania: National Institute for Medical Research |
Keywords provided by University of California, San Francisco:
|
femur fracture internal fixation intramedullary nailing |
Additional relevant MeSH terms:
|
Femoral Fractures Fractures, Bone Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 19, 2013