DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

Study Overview
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Brief Summary
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The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.

Detailed Description
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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.

Official Title
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Clinical Trial to Monitor the Clinical Effectiveness of the DePuy ATN Trochanteric Nailing System in the Treatment of Trochanteric Fractures of the Proximal Femur

Conditions
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Femoral Fracture (Proximal)

Intervention / Treatment
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* Device: Intramedullary nailing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and willing to sign the approved consent form. 18 years of age Skeletally mature Have stable or unstable proximal femur fracture, including pertrochanteric, intertrochanteric, high subtrochanteric or any combination of the AO Proximal Femur Fracture Classification Exclusion Criteria: Subjects with concomitant lower extremity injuries or multiple trauma that would interfere with normal hip fracture rehabilitation. Subjects who have isolated or combined medial femoral neck fractures. Subjects who are unwilling or unable to comply with a rehabilitation program or are unwilling or unable to be assessed for 1 year following surgery. Subjects who are pregnant or breastfeeding. Subjects who are a prisoner or a known alcohol or drug abuser. Subjects who have a prior surgical history in the affected hip, or conditions that may interfere with outcome or impede healing. Subjects who have an obliterated medullary canal or other conditions that may complicate the reaming process. Subjects who have evidence of active untreated infections that may spread to other areas of the body. Subjects who have a highly communicable disease or pathology that may limit follow-up. Subjects, who in the opinion of the Clinical Investigator, have an existing condition that indicates the Subject is not a good candidate for the study. Subjects who are participating in another clinical investigation. Subjects known to have allergies to titanium, aluminum, vanadium. Subjects who are currently eligible for workman's compensation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Monitoring of trochanteric fractures after treatment with the ATN system. | Device: Intramedullary nailing<br>* Trochanteric nailing for proximal femoral fractures.<br>* Other names: Ace Trochanteric Nail (ATN) system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in Terms of the Merle D'Aubigne Postel Score for Pain Category | Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately | 4 weeks, 3, 6 and 12 months | 
| Success in Terms of the Merle D'Aubigne Postel Score for Walk Category | Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately | 4 weeks, 3, 6 and 12 months | 
| Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category | Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately | 4 weeks, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Extremity Measure (LEM) |  | 4 weeks, 3, 6 and 12 months | 
| Medical Imaging |  | 4 weeks, 3, 6 and 12 months | 
| Six Item Screener and Ambulatory Status |  | 4 weeks, 3, 6 and 12 months | 
| SF-12 |  | 4 weeks, 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal femoral fracture, Trochanteric fracture, Intramedullary nailing