ceramic-on-ceramic (coc) 36mm acetabular bearing insert post approval study-new subjects (coc36mmpas)

Conditions: Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Post-Traumatic Osteoarthritis of Hip

Summary: this study is intended to gather short (pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm ceramax® ceramic on ceramic total hip system from a cohort of new study subjects that were not previously involved in the ide study for this device.

up to 10 (up to 5 original ide + 5 new sites) a prospective, non-controlled, non-randomized, multicenter study. subjects will be seen for a clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3 years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2555 days). data collected will include: pre-operatively subject history and demographics; operative and device details; and post-operatively harris hip scores, subject hip outcomes, and adverse events. in order to optimize mid-term follow-up compliance, site personnel are permitted to contact the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to assess the current status of the hip.

Eligibility criteria:
inclusion criteria: * males and females between 21 - 75 at the time of surgery. * individuals, who in the opinion of the investigator, are suitable candidates for primary total hip replacement using the devices specified in this protocol. * individuals with non-inflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic arthritis. * individuals who are willing and able to provide informed patient consent for participation in the study; * individuals who are willing and able to return for follow-up as specified by the study protocol; and * individuals who are willing and able to complete the subject hip outcomes questionnaire as specified by the study protocol. exclusion criteria: * skeletally immature patients (tibial and femoral epiphyses not closed) * evidence of active infections that may spread to other areas of the body (e.g.,osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.) * the presence of any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) disease * significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis) * presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.) * any condition that may interfere with postoperative recovery (e.g., paget's disease, charcot's disease) * inadequate bone stock to support the device (e.g., severe osteopenia orosteoporosis) * poor skin coverage around the hip joint * use in patients with known allergies to the implant materials * marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a birth defect affecting the leg bones. * inflammatory degenerative joint disease (like rheumatoid arthritis) * subject has participated in an ide/ind clinical investigation, other than the coc28/coc36 ide or pas for their contralateral hip, with an investigational product in the last three months. * subject is currently involved in a personal injury litigation, medical-legal or worker's compensation claims. * subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to comply with protocol procedures and/or subject-completed questionnaires. * the subject is a woman who is pregnant or lactating. * the subject has a medical condition with less than 2 years of life expectancy.

Keywords: total hip replacement total hip arthroplasty hip joint replacement hip prosthesis replacement