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

NCT00471913 | Completed

• 1 other identifier: H06-03242
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femoral Shaft Fracture

Keywords

Femur; Fracture; Antegrade; Nailing; Shaft; Abductor

Outcome Measures

Primary Outcomes (1)

• 12 month functional outcome and determination of muscle and tendon damage with MR Imaging

  12 months

Interventions

Femoral Nailing with Different Entry Points DEVICE

See Detailed Description.

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Pierre Guy, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: April 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 15, 2011

Record last verified: 2011-04

Locations

CA (1)