Multi-Site, Post-Market Study of the ICONACY I-Hip System
Status: | Recruiting |
---|---|
Conditions: | Osteoarthritis (OA), Orthopedic |
Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 30 - 80 |
Updated: | 4/2/2016 |
Start Date: | April 2014 |
End Date: | December 2019 |
Contact: | Donald L Pomeroy, MD |
Email: | arthroplastyfoundation@gmail.com |
Phone: | 502-364-9883 |
Non-Randomized, Multi-Site, Post-Market Study of the ICONACY I-Hip System (Protocol No. PS-1001)
The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total
hip replacement surgery.
hip replacement surgery.
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.
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