DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

DePuy Synthes

Status and phase: Completed; Phase 4

Conditions: Femoral Fracture (Proximal)

Treatments: Device: Intramedullary nailing

Study type: Observational

Funder types: Industry

Identifiers

NCT00546429

04077

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

62 participants in 1 patient group

A

Description:

Monitoring of trochanteric fractures after treatment with the ATN system.

Treatment:

Device: Intramedullary nailing