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Completed

NCT Number: NCT01548456

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

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.

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Key information

Conditions

Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Muhimbili Orthopaedic Institute

Dar es Salaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intramedullary nailing

Procedure

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 names: SIGN Intramedullary Nail

Open reduction internal fixation

Procedure

Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate

Primary outcomes

  1. Reoperation

    Time frame: 1-year

    Reoperation involving the affected femur for any reason within the first year will be considered an event.

Secondary outcomes

  1. Health-related quality of life

    Time frame: 1-year

    Health-related quality of life as measured by the EQ-5D-3L (Swahili version) by the Euroqol Group

  2. Return to work

    Time frame: 1-year

    Time from surgery to return to work among patients employed at the time of injury

  3. Clinical union

    Time frame: 1-year

    Defined as full painless weight bearing on the affected extremity

  4. Radiographic Union

    Time frame: 1-year

    Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Muhimbili Orthopaedic Institute
  • Orthopaedic Research Foundation
  • Orthopaedic Trauma Association

Registry information

Official study title

Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2012
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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