N/A
N=62
DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial
Femoral Fracture (Proximal)
Bottom Line
View on ClinicalTrials.gov: NCT00546429 ↗Enrolled (actual)
62
Serious AEs
4.8%
Results posted
Dec 2010
Primary outcome: Primary: Success in Terms of the Merle D'Aubigne Postel Score for Pain Category — 4.1; 4.4; 4.5; 4.6 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Intramedullary nailing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DePuy Orthopaedics
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success in Terms of the Merle D'Aubigne Postel Score for Pain Category |
4.1; 4.4; 4.5; 4.6 | — |
| PRIMARY Success in Terms of the Merle D'Aubigne Postel Score for Walk Category |
1.3; 2.6; 3.0; 2.7 | — |
| PRIMARY Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category |
5.2; 5.4; 5.4; 5.6 | — |
| SECONDARY Lower Extremity Measure (LEM) |
— | — |
| SECONDARY Medical Imaging |
— | — |
| SECONDARY Six Item Screener and Ambulatory Status |
— | — |
| SECONDARY SF-12 |
— | — |
Summary
The purpose of this study is to monitor trochanteric fracture healing and review the performance of 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.
Data sourced from ClinicalTrials.gov (NCT00546429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.