Functional Outcome and MRI of Muscle Damage Following Nailing Procedure in Femur (Thigh) Fractures Using Different Entry Points

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00471913
First received: May 8, 2007
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

Study focus is femoral shaft (thigh bone) fractures (break) that require surgical treatment under anaesthetic to stabilize the femur fracture. This is usually done by placing a metal nail and screws inside the femur (thigh) bone.

This study has been designed to allow us to learn more about the effect of using a different starting point to insert the nail into the body in order to access the fracture and fix it. This question is important because to date, all entry points currently used do result in some muscle damage. In order to minimize this damage a lateral (side) entry nail has been developed and is currently in use at many centres. This nail is new but, the lateral entry technique for these types of fractures has been used extensively in the past, and this nail has been developed in order to better accommodate the technique.

It is believed that entering laterally instead of going deeper into the tissue to access the bone to fix it is going to result in less muscle damage which in turn will improve functional outcome.


Condition Intervention
Femoral Shaft Fracture
Device: Femoral Nailing with Different Entry Points

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Outcome and MR Imaging of Abductor Damage Following Antegrade Femoral Nailing With Different Entry Points: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 12 month functional outcome and determination of muscle and tendon damage with MR Imaging [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Femoral Nailing with Different Entry Points
    See Detailed Description.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19 to 60 years of age
  • Isolated closed femoral shaft fracture
  • Ability to take part in follow-up and functional testing

Exclusion Criteria:

  • Patients under 19 and over 60 years of age
  • Non - traumatic/pathological fractures
  • Ipsilateral acetabulum/pelvis fracture
  • Open femoral shaft fracture
  • Previous lower extremity surgery
  • Pre-existing disability
  • Presents for revision surgery
  • Mentally incompetent to consent
  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: NCT00471913

Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Pierre Guy, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Pierre Guy, University of British Columbia
ClinicalTrials.gov Identifier: NCT00471913     History of Changes
Other Study ID Numbers: H06-03242
Study First Received: May 8, 2007
Last Updated: April 13, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Femur
Fracture
Antegrade
Nailing
Shaft
Abductor

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 19, 2014