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

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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.


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.
We found this trial at
2
sites
Louisville, Kentucky 40207
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