DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial
The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Success in Terms of the Merle D'Aubigne Score [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.
- Lower Extremity Measure (LEM) [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
- Medical Imaging [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
- Six Item Screener and Ambulatory Status [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
- SF-12 [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
- Merle d'Aubigne and Postel [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Monitoring of trochanteric fractures after treatment with the ATN system.
Device: Intramedullary nailing
Trochanteric nailing for proximal femoral fractures.
Other Name: Ace Trochanteric Nail (ATN) system
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.
|United States, Colorado|
|Front Range Orthopaedics|
|Colorado Springs, Colorado, United States, 80910|
|Orthopaedic Physicians of Colorado|
|Englewood, Colorado, United States, 80110|
|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|