Multi-Site, Post-Market Study of the ICONACY I-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 I-Hip for primary total hip replacement surgery.

Official Title
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Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)

Conditions
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Degenerative Joint Disease

Intervention / Treatment
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* Device: Iconacy Hip System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A candidate for primary hip replacement on this operative hip. Is 30 to 80 years of age. Has hip joint disease related to one or more of the following: Degenerative joint disease, (including osteoarthritis or post-traumatic arthritis) Avascular Necrosis (AVN). Will be available for evaluation for the duration of the study. Is able and willing to speak and read English, read and sign the informed consent, fill out the WOMAC and Patient Satisfaction questionnaires, and follow all study procedures. Exclusion Criteria: Is younger than 30 years of age or older than 80 years of age. Has undergone partial hip replacement or previous ORIF (open reduction internal fixation of femur or acetabulum). Has undergone total hip replacement on this hip in the past (no revisions allowed in study). Infection, or history of infection, acute or chronic, in the hip joint, or acute or chronic unresolved systemic infection. Is currently experiencing radicular pain from the spine down operative leg. Has participated in an IDE/IND clinical investigation with an investigational product in the last three months, or is involved in any personal injury litigation, medical-legal or worker's compensation claim. Is a known drug or alcohol abuser or has a psychological disorder that could affect the ability to complete patient reported questionnaires. Has been diagnosed with fibromyalgia or has a significant neurological or musculoskeletal disorder or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease). Has been diagnosed with Paget's disease or Congenital hip deformity (dysplasia and/or dislocation). Is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.) Is Obese: (Defined for this study as having a BMI>45). Has insufficient bone quality. Has loss of ligamentous structures. Has materials sensitivity. Is currently a prisoner. Is pregnant or lactating. Has a contralateral amputation. Has a medical condition with less than 2 years of life expectancy.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Iconacy Hip System<br>Iconacy hip system prosthesis components | Device: Iconacy Hip System<br> <br> * Other names: iHip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Success as a Measure of Radiolucency and Component Migration | A subject will be considered a failure for Overall Radiographic Success if one or more of the below conditions are met: The subject will be considered a RADIOGRAPHIC FAILURE if: there is a complete radiolucent line> 3mm wide at the bone/cement interface or there is a >5 degree migration (shift) of the component or there is a >5 mm migration (shift) of the component. | 2 years | 
| Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered) |  | 2 years | 
| Patient satisfaction clinical assessment utilizing questionnaire | Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision of Implant Prosthesis as a Measure of Efficacy |  | 5 years | 

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