Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Michigan Hand Questionnaire (MHQ)
研究概览
简要总结
The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.
The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •primary osteoarthritis in the distal interphalangeal joint
- •require surgical treatment
- •patient aged 18 years and over
- •signed written informed consent
排除标准
- •posttraumatic osteoarthritis
- •rheumatoid disease
- •pregnant woman
- •any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- •legal incompetence
- •no knowledge of German
结局指标
主要结局
Michigan Hand Questionnaire (MHQ)
时间窗: 12 months postoperative
Comparison of silicone arthroplasty and arthrodesis in respect to MHQ
次要结局
- Change of Michigan Hand Questionnaire Score(preoperative, 3mo/6mo/36mo postoperative)
研究者
Sebastian Kluge
Dr. med.
Schulthess Klinik