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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Orthopaedic Research Foundation
Orthopaedic Trauma Association
Muhimbili Orthopaedic Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01548456
First received: February 27, 2012
Last updated: April 14, 2014
Last verified: April 2014

February 27, 2012
April 14, 2014
July 2012
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01548456 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.

Femoral Fractures
  • 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
  • Procedure: Open Reduction Internal Fixation
    Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate
  • Intramedullary nailing
    Subjects with a femur fracture who undergo operative fixation with an intramedullary nail
    Intervention: Procedure: Intramedullary Nailing
  • Open Reduction Internal Fixation
    Subjects with a femur fracture who undergo open reduction internal fixation with a dynamic compression plate
    Intervention: Procedure: Open Reduction Internal Fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
333
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01548456
UCSF 23346
No
University of California, San Francisco
University of California, San Francisco
  • Orthopaedic Research Foundation
  • Orthopaedic Trauma Association
  • Muhimbili Orthopaedic Institute
Principal Investigator: David W Shearer, MD, MPH University of California, San Francisco
Study Director: Edmund N Eliezer, MD Muhimbili Orthopaedic Institute
University of California, San Francisco
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP