Functional Outcome and MRI of Muscle Damage Following Nailing Procedure in Femur (Thigh) Fractures Using Different Entry Points
|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.|
|ClinicalTrials.gov Identifier: NCT00471913|
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : April 15, 2011
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 or disease||Intervention/treatment||Phase|
|Femoral Shaft Fracture||Device: Femoral Nailing with Different Entry Points||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Outcome and MR Imaging of Abductor Damage Following Antegrade Femoral Nailing With Different Entry Points: A Prospective Randomized Trial|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Device: Femoral Nailing with Different Entry Points
- 12 month functional outcome and determination of muscle and tendon damage with MR Imaging [ Time Frame: 12 months ]
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
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Pierre Guy, MD||University of British Columbia|