DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

Femoral Fracture (Proximal) Clinical Trial

— ATN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546429
• Other study ID #: 04077
• Status: Completed
• Start date: September 1, 2006
• Est. completion date: September 1, 2009

Study information

• Verified date: June 2023
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 1, 2009
• Est. primary completion date: September 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fracture (Proximal)
• Femoral Fractures
• Fractures, Bone

Intervention

Device:
• Intramedullary nailing
Trochanteric nailing for proximal femoral fractures.

Locations

Country	Name	City	State
United States	Blue Ridge Bone and Joint	Asheville	North Carolina
United States	Erie County Medical Center	Buffalo	New York
United States	Front Range Orthopaedics	Colorado Springs	Colorado
United States	Orthopaedic Physicians of Colorado	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Lower Extremity Measure (LEM)		4 weeks, 3, 6 and 12 months
Secondary	Medical Imaging		4 weeks, 3, 6 and 12 months
Secondary	Six Item Screener and Ambulatory Status		4 weeks, 3, 6 and 12 months
Secondary	SF-12		4 weeks, 3, 6 and 12 months