Clinical trial NCT00546429: DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Fracture (Proximal)
Keywords: Proximal femoral fracture
Trochanteric fracture
Intramedullary nailing
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE

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

Primary outcomes:
measure: Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
timeFrame: 4 weeks, 3, 6 and 12 months
measure: Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
timeFrame: 4 weeks, 3, 6 and 12 months
measure: Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
timeFrame: 4 weeks, 3, 6 and 12 months
Secondary outcomes:
measure: Lower Extremity Measure (LEM)
timeFrame: 4 weeks, 3, 6 and 12 months
measure: Medical Imaging
timeFrame: 4 weeks, 3, 6 and 12 months
measure: Six Item Screener and Ambulatory Status
timeFrame: 4 weeks, 3, 6 and 12 months
measure: SF-12
timeFrame: 4 weeks, 3, 6 and 12 months
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Front Range Orthopaedics
state: Colorado
city: Englewood
country: United States
facility: Orthopaedic Physicians of Colorado
state: Colorado
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Asheville
country: United States
facility: Blue Ridge Bone and Joint
state: North Carolina
Study officials:
affiliation: DePuy Orthopaedics
name: Sam Himden
role: STUDY_DIRECTOR
References: