DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

NCT ID: NCT00546429

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-01
• Study Completion Date: 2009-09-01

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.

Conditions

Femoral Fracture (Proximal)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Monitoring of trochanteric fractures after treatment with the ATN system.

Intramedullary nailing

Intervention Type: DEVICE

Trochanteric nailing for proximal femoral fractures.

Interventions

Intramedullary nailing

Trochanteric nailing for proximal femoral fractures.

Intervention Type: DEVICE

Other Intervention Names

Ace Trochanteric Nail (ATN) system

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Himden

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

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

Countries

United States

Other Identifiers

04077

Identifier Type: -

Identifier Source: org_study_id