Multi-Site, Post-Market Study of the ICONACY I-Hip System
- Conditions
- Degenerative Joint Disease
- Interventions
- Device: Iconacy Hip System
- Registration Number
- NCT02131389
- Lead Sponsor
- Iconacy Orthopedic Implants, LLC.
- Brief Summary
The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Iconacy Hip System Iconacy Hip System Iconacy hip system prosthesis components
- Primary Outcome Measures
Name Time Method Radiographic Success as a Measure of Radiolucency and Component Migration 2 years 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:
1. there is a complete radiolucent line\> 3mm wide at the bone/cement interface or
2. there is a \>5 degree migration (shift) of the component or
3. there is a \>5 mm migration (shift) of the component.Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered) 2 years Patient satisfaction clinical assessment utilizing questionnaire 2 years Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.
- Secondary Outcome Measures
Name Time Method Revision of Implant Prosthesis as a Measure of Efficacy 5 years
Trial Locations
- Locations (2)
Baptist Health Louisville
🇺🇸Louisville, Kentucky, United States
Sts. Mary & Elizabeth Hospital - KentuckyOne Health
🇺🇸Louisville, Kentucky, United States