DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

NCT00546429 | Completed Results

• 1 other identifier: 04077
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Femoral Fracture (Proximal)

Keywords

Proximal femoral fracture; Trochanteric fracture; Intramedullary nailing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (1)

A

Monitoring of trochanteric fractures after treatment with the ATN system.

Device: Intramedullary nailing

Interventions

Intramedullary nailing DEVICE

Trochanteric nailing for proximal femoral fractures.

Also known as: Ace Trochanteric Nail (ATN) system

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willing to sign the approved consent form.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (4)

Front Range Orthopaedics

Colorado Springs, Colorado, 80910, United States

Location

Orthopaedic Physicians of Colorado

Englewood, Colorado, 80110, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Blue Ridge Bone and Joint

Asheville, North Carolina, 28801, United States

Location

MeSH Terms

Conditions

Proximal Femoral Fractures; Hip Fractures

Interventions

Fracture Fixation, Intramedullary; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Drug Therapy

Results Point of Contact

• Title: Sam Himden
• Organization: DePuy Orthopaedics, Inc.

SHimden@its.jnj.com

574-372-7231

Study Officials

• Sam Himden

  DePuy Orthopaedics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 19, 2007
• Study Start: September 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 6, 2023
• Results First Posted: December 10, 2010

Record last verified: 2023-06

Locations

US (4)