ACTRN12608000234314已完成4 期
A prospective, multicenter, non-randomized study to evaluate the safety and efectiveness of the R3 Acetabular Hip System in patients with degenerative joint disease.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 /A（—）
- 性别
- All
入选标准
- •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/DDH).
- •3.Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk.
- •4 The patient will be available for follow-up throughout the duration of the study.
排除标准
- •Subjects 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
- •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 or osteopenia)
- •5.Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
- •6.Patient has known moderate to severe renal insufficiency.
- •6.Patient has a known or suspected metal sensitivity.
- •7.Patient is immunosuppressed with diseases such as AIDS or receiving
- •high doses of corticosteroids.
- •8.Patient has an emotional or neurological condition that would pre-empt
- •their ability or unwillingness to participate in the study including mental
- •illness, mental retardation, or drug, alcohol abuse.
- •9.Patient is severely overweight.
研究者
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