Post-Market Study of the ICONACY Hip System

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

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

Conditions
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Degenerative Joint Disease

Intervention / Treatment
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* Device: Iconacy Hip System
* Device: Stryker Accolade Hip System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iconacy Hip System<br>Iconacy hip system prosthesis components | Device: Iconacy Hip System<br>* Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.<br>* Other names: iHip;|
| Active Comparator: Stryker Accolade Hip System<br>Stryker Accolade hip system prosthesis components | Device: Stryker Accolade Hip System<br>* Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.<br>* Other names: Accolade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic success |  | 2 years | 
| Harris Hip Score must be > or = 80 at 2 years |  | 2 years | 
| Oxford Hip Score > 40 points at 2 years |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Arthroplasty, Arthroplasties, Prosthesis, Iconacy, Osteoarthritis, Arthritis, THA, THR, DJD