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Sponsored by: |
DePuy Orthopaedics |
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Information provided by: | DePuy Orthopaedics |
ClinicalTrials.gov Identifier: | NCT00546429 |
The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.
Condition | Intervention | Phase |
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Femoral Fracture (Proximal) |
Device: Intramedullary nailing |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Trial to Monitor the Clinical Effectiveness of the DePuy ATN Trochanteric Nailing System in the Treatment of Trochanteric Fractures of the Proximal Femur |
Estimated Enrollment: | 60 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A
Monitoring of trochanteric fractures after treatment with the ATN system.
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Device: Intramedullary nailing
Trochanteric nailing for proximal femoral fractures.
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Proximal femoral fractures are among the most common femoral fractures. In the past plates and screws were often used to repair these fractures but this treatment had limitations including restricted weight bearing. Intermedullary nailing is an alternative to plate and screw treatment. Weight bearing is allowed and the procedure can be a less invasive. Among intramedullary nailing complications are iatrogenic fractures that can be further divided into trochanteric and femoral shaft fractures. Trochanteric fractures often heal without additional intervention however femoral shaft fractures usually require an additional surgical procedure to facilitate healing. This study will monitor fracture healing using clinical and radiographic evaluations of subjects with trochanteric fractures of the proximal femur treated with the ATN system.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
Orthopaedic Physicians of Colorado | |
Englewood, Colorado, United States, 80110 | |
Front Range Orthopaedics | |
Colorado Springs, Colorado, United States, 80910 | |
United States, Mississippi | |
North Mississippi Sports Medicine & Orthopaedic Clinic, PLLC | |
Tupelo, Mississippi, United States, 38801 | |
United States, New York | |
Erie County Medical Center | |
Buffalo, New York, United States, 14215 | |
United States, North Carolina | |
Blue Ridge Bone and Joint | |
Asheville, North Carolina, United States, 28801 |
Study Director: | Sam Himden | DePuy Orthopaedics, Inc. |
Responsible Party: | DePuy Orthopaedics ( Sam Himden ) |
Study ID Numbers: | 04077 |
Study First Received: | October 17, 2007 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00546429 History of Changes |
Health Authority: | United States: Institutional Review Board |
Proximal femoral fracture Trochanteric fracture Intramedullary nailing |
Hip Fractures Femoral Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries |
Hip Fractures Femoral Fractures Fractures, Bone Wounds and Injuries |
Disorders of Environmental Origin Leg Injuries Hip Injuries |