Multi-Site, Post-Market Study of the ICONACY I-Hip System

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.