DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
A	Intramedullary nailing	Monitoring of trochanteric fractures after treatment with the ATN system.

Primary Outcome Measures

Name	Time	Method
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category	4 weeks, 3, 6 and 12 months	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
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category	4 weeks, 3, 6 and 12 months	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
Success in Terms of the Merle D'Aubigne Postel Score for Pain Category	4 weeks, 3, 6 and 12 months	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

Secondary Outcome Measures

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

Locations (4): Front Range Orthopaedics
🇺🇸
Colorado Springs, Colorado, United States
Erie County Medical Center
🇺🇸
Buffalo, New York, United States
Orthopaedic Physicians of Colorado
🇺🇸
Englewood, Colorado, United States
Blue Ridge Bone and Joint
🇺🇸
Asheville, North Carolina, United States