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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471913
First Posted: May 10, 2007
Last Update Posted: April 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of British Columbia
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Pierre Guy, University of British Columbia
ClinicalTrials.gov Identifier: NCT00471913     History of Changes
Other Study ID Numbers: H06-03242
First Submitted: May 8, 2007
First Posted: May 10, 2007
Last Update Posted: April 15, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries