Skip to main content
OpenTrials
Completed

NCT Number: NCT00546429

DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Front Range Orthopaedics, Colorado Springs, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intramedullary nailing

Device

Trochanteric nailing for proximal femoral fractures.

Other names: Ace Trochanteric Nail (ATN) system

Primary outcomes

  1. Success in Terms of the Merle D'Aubigne Postel Score for Pain Category

    Time frame: 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

  2. Success in Terms of the Merle D'Aubigne Postel Score for Walk Category

    Time frame: 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

  3. Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category

    Time frame: 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 outcomes

  1. Lower Extremity Measure (LEM)

    Time frame: 4 weeks, 3, 6 and 12 months

  2. Medical Imaging

    Time frame: 4 weeks, 3, 6 and 12 months

  3. Six Item Screener and Ambulatory Status

    Time frame: 4 weeks, 3, 6 and 12 months

  4. SF-12

    Time frame: 4 weeks, 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

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

Acronym: ATN

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 19, 2007
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.