NCT00698750终止不适用
A Prospective, Non-controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 主要终点
- X-rays
研究概览
简要总结
The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- •Rheumatoid arthritis
- •Correction of functional deformity
- •Reconstructable Rotator Cuff
- •Treatment of acute fracture of the humeral head
- •Traumatic arthritis
排除标准
- •Patients less than 18 years.
- •Patients with rapid joint destruction, osteomalacia, osteoporosis, or marked bone loss, which would preclude proper fixation of the prosthesis.
- •Patients with marked bone loss apparent on roentgenogram.
- •Metabolic disorders, which may impair bone formation.
- •Patients who are pregnant.
- •Patients with an active or suspected infection in or around the shoulder or distant foci of infections, which may spread to the implant site.
- •Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue, which would prelude stability of the prosthesis.
- •Patients who have had revision procedures where other devices or treatments have failed.
- •Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc).
- •Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless partial or total shoulder replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
- •Patients with previous shoulder surgery or conditions that may interfere with the partial or total shoulder replacement's survival or outcome.
- •Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
- •Patients who have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year.
结局指标
主要结局
X-rays
时间窗: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
ASES Assessment
时间窗: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
次要结局
- Incidence of revision or removals(Any time)
研究者
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