DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

Completed

Conditions studied: Femoral Fracture (Proximal)

In brief

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

Key facts

Study ID

NCT00546429

Run by

DePuy Orthopaedics

People needed

62

Starts

2006-09-01

Expected to finish

2009-09-01

Last updated by the study team

2023-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Front Range Orthopaedics — Colorado Springs, Colorado, United States
• Orthopaedic Physicians of Colorado — Englewood, Colorado, United States
• Erie County Medical Center — Buffalo, New York, United States
• Blue Ridge Bone and Joint — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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