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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546429
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : December 10, 2010
Last Update Posted : February 29, 2012
Information provided by (Responsible Party):
DePuy Orthopaedics

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

Condition or disease Intervention/treatment Phase
Femoral Fracture (Proximal) Device: Intramedullary nailing Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Monitoring of trochanteric fractures after treatment with the ATN system.
Device: Intramedullary nailing
Trochanteric nailing for proximal femoral fractures.
Other Name: Ace Trochanteric Nail (ATN) system

Primary Outcome Measures :
  1. Success in Terms of the Merle D'Aubigne Score [ Time Frame: 4 weeks, 3, 6 and 12 months ]
    Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.

Secondary Outcome Measures :
  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 ]
  5. Merle d'Aubigne and Postel [ Time Frame: 4 weeks, 3, 6 and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546429

United States, Colorado
Front Range Orthopaedics
Colorado Springs, Colorado, United States, 80910
Orthopaedic Physicians of Colorado
Englewood, Colorado, United States, 80110
United States, New York
Erie County Medical Center
Buffalo, New York, United States, 14215
United States, North Carolina
Blue Ridge Bone and Joint
Asheville, North Carolina, United States, 28801
Sponsors and Collaborators
DePuy Orthopaedics
Study Director: Sam Himden DePuy Orthopaedics

Responsible Party: DePuy Orthopaedics Identifier: NCT00546429     History of Changes
Other Study ID Numbers: 04077
First Posted: October 19, 2007    Key Record Dates
Results First Posted: December 10, 2010
Last Update Posted: February 29, 2012
Last Verified: February 2012

Keywords provided by DePuy Orthopaedics:
Proximal femoral fracture
Trochanteric fracture
Intramedullary nailing

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Hip Fractures
Wounds and Injuries
Leg Injuries
Hip Injuries