ICONACY Hip Clinical Data Acquisition (13-1-M-239)

Overview

The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

December 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•This must be a primary hip replacement on this hip
•Patient is 30 years of age or older
•Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
•Patient is likely to be available for evaluation for the duration of the study
•Able and willing to sign the informed consent and follow study procedures

•Is younger than 30 years of age
•If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
•Infection, or history of infection, acute or chronic, local or systemic
•Alcoholism or other addictions
•Muscular, neurological or vascular deficiencies which compromise the affected extremity
•Obesity(BMI\>45)
•Insufficient bone quality
•Loss of ligamentous structures
•High levels of physical activity
•Materials sensitivity

Harris Hip Score must be > or = 80 at 2 years

Time Frame: 2 years

Radiographic success

Time Frame: 2 years

Oxford Hip Score > 40 points at 2 years

Time Frame: 2 years

Patient Satisfaction at 1, 2, and 3 years(1, 2, and 3 years)
Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years(1, 2, and 3 years)
Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years(1, 2, and 3 years)