DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial (ATN)

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

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

Study Overview

• Status: Completed
• Conditions: Femoral Fracture (Proximal)
• Intervention / Treatment: Device: Intramedullary nailing

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.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Front Range Orthopaedics
    • Englewood, Colorado, United States, 80110
      • Orthopaedic Physicians of Colorado
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Blue Ridge Bone and Joint

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; Monitoring of trochanteric fractures after treatment with the ATN system.	Device: Intramedullary nailing; Trochanteric nailing for proximal femoral fractures.; Other Names: Ace Trochanteric Nail (ATN) system

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Sam Himden, DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: October 18, 2007
• First Posted (Estimated): October 19, 2007

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Intramedullary nailing; Trochanteric fracture; Proximal femoral fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 04077