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

NCT01548456 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 332

Last updated 2015-05-19

No results posted yet for this study

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.

Conditions

  • Femoral Fractures

Interventions

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

PROCEDURE

Open Reduction Internal Fixation

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

Sponsors & Collaborators

  • Orthopaedic Research Foundation

    collaborator OTHER

  • Orthopaedic Trauma Association

    collaborator OTHER

  • Muhimbili Orthopaedic Institute

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • David W Shearer, MD, MPH · University of California, San Francisco

  • Edmund N Eliezer, MD · Muhimbili Orthopaedic Institute

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Tanzania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01548456 on ClinicalTrials.gov