NL-OMON56094招募中不适用
Wrist implant safety evaluation (WISE) study - Wise study
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Signed and dated written informed consent prior to admission to the clinical
- •study in accordance with good clinical practice (GCP) and local legislation;
- •- Male >18 years of age and post menopausal females;
- •- Diagnosed with posttraumatic radiocarpal osteoarthritis as diagnosed with an
- •X-ray and/or CT scan of the wrist;
排除标准
- •- Previous surgery for posttraumatic radiocarpal osteoarthritis, with in
- •particular salvage procedures such as excisional arthroplasty (proximal row
- •carpectomy), total wrist arthrodesis and total wrist arthroplasty; Prior
- •reconstructive procedures are not exclusion criteria;
- •- General objections for surgery, determined after anaesthesiologic
- •assessment;
- •- Radiocarpal osteoarthritis including the midcarpal joint;
- •- Acute or chronic infection of the radiocarpal joint;
- •- Diagnosed rheumatoid arthritis of the radiocarpal joint;
- •- Unwilling to cooperate with the study protocol and follow up schedule;
- •- Judged by the surgeon mentally incapable to follow study requirements;
- •- Diagnosed with neuromuscular or neuro-sensory deficit which would limit the
- •ability to assess the performance of the radiocarpal interposition arthroplasty;
- •- Diagnosed with active malignancy;;
- •- Known systemic or metabolic disorders leading to progressive bone
- •deterioration;
- •- Use of systemic corticosteroids within the last 3 months (inhaled steroids
- •are no reason for exclusion);
- •- Presence of an active or suspected infection;
- •- Uncontrolled diabetes mellitus as determined by treating physicians;
研究者
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