Post-Market Study of the ICONACY Hip System

Iconacy Orthopedic Implants

Status

Withdrawn

Conditions

Degenerative Joint Disease

Treatments

Device: Iconacy Hip System

Device: Stryker Accolade Hip System

Study type

Interventional

Funder types

Industry

Identifiers

13-1-M-239

Details and patient eligibility

About

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

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Prisoner
Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
Patient is pregnant
Is not able to read English language