Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

Exclusion Criteria

• •1. have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms as determined by the clinician /investigator.
• •2. have a neurological disorders which may interfere or adversely affect gait, balance, or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
• •3. diagnosed with metabolic disorders (e.g. osteomalacia), which may impair bone metabolism.
• •4. diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
• •5. immunologically suppressed.
• •6. receiving systemic steroid therapy, excluding inhalers, within 3 months prior to surgery.
• •7. diagnosed Charcot's disease, metastatic or neoplastic disease.
• •8. evidence of active infections that may spread to other areas of the body (e.g. osteomyelitis, pyogenic infection of the hip joint, overt infection, untreated urinary tract infection, etc.).
• •9. presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
• •10. previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
• •11. diagnosed with systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis or other diagnoses with autoimmune etiology.
• •12. diagnosed with osteoporosis or as evidenced on a DEXA scan for males over 75 or females over 65 years of age (within the last 12 months).
• •13. require structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
• •14. have acute femoral neck fracture or hip fractures.
• •15. have an above the knee amputation of the contralateral and/or ipsilateral leg.
• •16. have an existing total hip arthroplasty in the contralateral hip with a pain rating of 3 or more on a scale of 0 to 10, where 0 is "no pain" and 10 is "severe pain".
• •17. have had a total hip arthroplasty in the contralateral hip within the past 12 months.
• •18. have previously received a metal-on-metal hip arthroplasty.
• •19. have a highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis, etc.).
• •20. have any known sensitivity to device material.
• •21. Females who are pregnant.
• •22. Patients who are prisoners.