Femoral Fractures
Conditions
Keywords
femur fracture, internal fixation, intramedullary nailing
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.
Interventions
PROCEDUREIntramedullary 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
PROCEDUREOpen Reduction Internal Fixation
Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate
Sponsors
Orthopaedic Research Foundation
Orthopaedic Trauma Association
Muhimbili Orthopaedic Institute
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation | 1-year | Reoperation involving the affected femur for any reason within the first year will be considered an event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Clinical union | 1-year | Defined as full painless weight bearing on the affected extremity |
| Radiographic Union | 1-year | Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score |
Countries
Tanzania
Outcome results
None listed