Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study

Ki vehet részt

• Patient is 21 to 75 years of age, inclusive
• Patient is skeletally mature
• Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:; Avascular necrosis (AVN); Osteoarthritis (OA); Inflammatory arthritis (i.e. Rheumatoid arthritis); Post-traumatic arthritis
• Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s)
• Patient has a Harris Hip Score <70 in the affected hip
• Patient is willing and able to provide written informed consent
• Patient is willing and able to cooperate in the required post-operative therapy
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent
• Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent

Ki nem vehet részt

• The patient is:; A prisoner; Mentally incompetent or unable to understand what participation in the study entails; A known alcohol or drug abuser; Anticipated to be non-compliant
• The patient has had previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be operated
• The patient has received an investigational drug or device within the previous 6 months
• The patient has undergone a total hip replacement, endoprosthesis, or surface arthroplasty of the contralateral (opposite side) hip within the past 6 months regardless of whether the previous hip was enrolled in this clinical study
• The patient has had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated
• The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care
• The patient has a vascular (large and small vessel disease) insufficiency
• The patient has a chronic renal impairment or failure
• The patient has a neurologic condition in the ipsolateral or contralateral limb which affects lower limb function
• The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome
• The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously
• The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock
• The patient has a known sensitivity or allergic reaction to one or more of the implanted materials
• The patient is known to be pregnant
• The patient is unwilling or unable to give informed consent, or to comply with the follow-up program
• The patient has known local bone tumors and/or cysts in the operative hip
• The patient is Grade III obese with a Body Mass Index (BMI) > 35
• The patient has osteoradionecrosis in the affected hip joint