DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

Clinical Trial to Monitor the Clinical Effectiveness of the DePuy ATN Trochanteric Nailing System in the Treatment of Trochanteric Fractures of the Proximal Femur

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00546429

Acronym

ATN

Enrollment

Registered

2007-10-19

Start date

2006-09-01

Completion date

2009-09-01

Last updated

2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Fracture (Proximal)

Keywords

Proximal femoral fracture, Trochanteric fracture, Intramedullary nailing

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.

Interventions

DEVICEIntramedullary nailing

Trochanteric nailing for proximal femoral fractures.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Success in Terms of the Merle D'Aubigne Postel Score for Pain Category	4 weeks, 3, 6 and 12 months	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
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category	4 weeks, 3, 6 and 12 months	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
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category	4 weeks, 3, 6 and 12 months	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

Secondary

Measure	Time frame
Lower Extremity Measure (LEM)	4 weeks, 3, 6 and 12 months
SF-12	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

Countries

United States

Participant flow

Recruitment details

Between September 2006 & September 2009, 62 subjects were recruited and enrolled at 6 US clinics by orthopaedic surgeons. Each study site could enroll up to 20 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.

Pre-assignment details

This was a non-randomized study so all subjects that met the inclusion/exclusion criteria received the ATN Trochanteric Nail. Consented subjects could be excluded from the trial based on results of pre-operative clinical and/or radiographic evaluations, as per the exclusion criteria in the clinical investigation plan.

Participants by arm

Arm	Count
DePuy Orthopaedics ATN Trochanteric Nail System The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.	62
Total	62

Baseline characteristics

Characteristic	DePuy Orthopaedics ATN Trochanteric Nail System
Age, Continuous	79.2 years STANDARD_DEVIATION 14.1
Region of Enrollment United States United States	62 Participants
Sex: Female, Male Female	42 Participants
Sex: Female, Male Male	20 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	4 / 62
serious Total, serious adverse events	3 / 62

Outcome results

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