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

NCT01548456 | Completed

• 1 other identifier: UCSF 23346
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Fractures

Keywords

femur fracture; internal fixation; intramedullary nailing

Outcome Measures

Primary Outcomes (1)

• Reoperation

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

  1-year

Secondary Outcomes (4)

• Health-related quality of life

  1-year

• Return to work

  1-year

• Clinical union

  1-year

• Radiographic Union

  1-year

Study Arms (2)

Intramedullary nailing

Subjects with a femur fracture who undergo operative fixation with an intramedullary nail

Procedure: Intramedullary Nailing

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

Interventions

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

Also known as: SIGN Intramedullary Nail

Intramedullary nailing

Open Reduction Internal Fixation PROCEDURE

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

Open Reduction Internal Fixation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate
• Age 18 to 65

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Orthopaedic Research Foundation: collaborator
• Orthopaedic Trauma Association: collaborator
• Muhimbili Orthopaedic Institute: collaborator

Study Sites (1)

Muhimbili Orthopaedic Institute

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Femoral Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• David W Shearer, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Edmund N Eliezer, MD

  Muhimbili Orthopaedic Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 8, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

TA (1)