A prospective Radiostereometric Analysis (RSA) study to predict long-term safety and effectiveness of the cementless Total Hip System (CL2 stem / C2 cup) in patients with degenerative hip disease.

Joint Research Pty Ltd0 个研究点目标入组 25 人开始时间: 2010年9月29日最近更新: 2020年1月13日

试验速览

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•1.Patient requires unilateral primary total hip arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/developmental dysplasia of the hip (DDH) who are candidates for an cementless total hip system as determined jointly by the surgeon and patient.
•2.Have type A or type B femoral bone.
•3.Male and non-pregnant female patients aged 18 to 75.
•4.Patients who understand the conditions of the study and are willing and able to give written informed consent to participate in the length of the study including prescribed follow-ups.

•1.Patient has active infection or sepsis (treated or untreated).
•2.Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
•3.Patient is female of child-bearing age and not taking contraceptive precautions.
•4.Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis).
•5.Patient has inflammatory joint disease (e.g. rheumatoid arthritis).
•6.Patient has known moderate to severe renal insufficiency.
•7.Patient has a known or suspected metal sensitivity.
•8.Patient is immunosuppressed with diseases such as acquired immunodeficiency syndrome (AIDS) or receiving high doses of corticosteroids.
•9.Patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the Clinical Evaluation including mental illness, mental retardation, or drug, alcohol abuse.
•10.Patient is severely overweight. Body Mass Index (BMI )> 40.

发起方

Joint Research Pty Ltd