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
  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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548456

Locations
Tanzania
Muhimbili Orthopaedic Institute
Dar es Salaam, Tanzania
Sponsors and Collaborators
University of California, San Francisco
Orthopaedic Research Foundation
Orthopaedic Trauma Association
Muhimbili Orthopaedic Institute
Investigators
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: April 14, 2014
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 July 23, 2014