Clinical trial NCT01548456: Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania
Official title: Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Fractures
Keywords: femur fracture
internal fixation
intramedullary nailing
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Orthopaedic Research Foundation
name: Orthopaedic Trauma Association
name: Muhimbili Orthopaedic Institute
First posted: 2012-03-08
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reoperation
timeFrame: 1-year
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 1-year
measure: Return to work
timeFrame: 1-year
measure: Clinical union
timeFrame: 1-year
measure: Radiographic Union
timeFrame: 1-year
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili Orthopaedic Institute
Study officials:
affiliation: University of California, San Francisco
name: David W Shearer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili Orthopaedic Institute
name: Edmund N Eliezer, MD
role: STUDY_DIRECTOR
References: