DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00546429
First received: October 17, 2007
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Femoral Fracture (Proximal)
Device: Intramedullary nailing
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Success in Terms of the Merle D'Aubigne Score [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    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:
  • Lower Extremity Measure (LEM) [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Medical Imaging [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Six Item Screener and Ambulatory Status [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Merle d'Aubigne and Postel [ Time Frame: 4 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546429

Locations
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
Investigators
Study Director: Sam Himden DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00546429     History of Changes
Other Study ID Numbers: 04077
Study First Received: October 17, 2007
Results First Received: September 29, 2010
Last Updated: February 28, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014