A Radiostereometric Analysis (RSA) study of the Hyperion uncemented stem in patients with degenerative hip disease

Australian Orthopaedic Fixation Pty Ltd0 个研究点目标入组 40 人开始时间: 2010年10月28日最近更新: 2020年1月13日

试验速览

暂无简介。

•Patients must meet all of the following characteristics for inclusion in the study.
•1.Patient is of legal age to consent and skeletally mature.
•2.Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia or developmental dysplasia of the hip (DDH)) who are candidates for an uncemented femoral stem as determined jointly by the surgeon and patient.
•3.Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk.
•4.Patient who understands the conditions of the study and are willing and able to give written informed consent to participate in the length of the study and prescribed follow-ups.

•Patients with any of the following characteristics must be excluded from participation in the study.
•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 post-operative 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 Aquired Immune Deficiency 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 study including mental illness, intellectual disability, or drug, alcohol abuse.
•10.Patient is severely overweight. Body Mass Index ( BMI) > 40.

发起方

Australian Orthopaedic Fixation Pty Ltd