Project JAY THA Registration Study

This is an interventional treatment trial for Osteoarthritis Read More

Inclusion Criteria:

• Male or female subjects, aged between 50 and 75 years inclusive of Chinese ethnicity.
• Subject presents with osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis of hip joint, developmental dysplasia of the hip, or femoral neck fracture requiring primary total hip replacement.
• Subject who is able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained by signing and dating an EC-approved consent form.
• Subject who is able to understand this clinical study, co-operates with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.
• Life expectancy of subject is over 2 years.

Exclusion Criteria:

• Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 12 months).
• Subject experienced prior joint replacement surgery on any major joint (hip, knee) in lower limb within the last 12 months.
• Subject with developmental dysplasia of the hip of CROWE grade 3 or 4.
• Subject has known or suspected metal sensitivity.
• Subject is known to have insufficient bone stock resulting from conditions such as cancer, significant osteoporosis or metabolic bone disorders, which cannot provide adequate support and/or fixation to the prosthesis.
• Subject is severely obese (BMI>35).
• Subject had an active infection or sepsis (treated or untreated).
• Subject has conditions that may compromise implant stability or postoperative recovery (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency, hip abduction muscle strength less than grade IV or complete loss, or neuromuscular disease).
• Subject has an emotional or neurological condition that would affect their ability or willingness to participate in the study (e.g. cognitive disorder, mental illness, mental retardation).
• Subject is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder. For examples, subject is on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or has acquired immunodeficiency syndrome (AIDS).
• Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
• Subject was enrolled in another investigational drug, biologic, or device study in the last 12 months.
• Subject is a woman who is pregnant or lactating，or intends to become pregnant during the course of the study.
• Known alcohol and/or drug abuse