NCT06154421招募中不适用
Metacarpophalangeal Joint Prostheses in Hand Surgery. A Retrospective Investigation on Functional Outcome After Intervention.
Waldfriede Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
研究概览
简要总结
The primary working hypothesis of this study is whether KeriFlex® metacarpophalangeal joint prostheses provide an equivalent result to Swanson finger joint implants in patients with rheumatoid arthritis or post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90
- •Metacarpophalangeal Joint Prostheses between 2014 and 2022 using Swanson or KeriFlex implant system at Hospital Waldfriede
- •rheumatoid Arthritis or post-traumatic osteoarthritis of Metacarpophalangeal joint
排除标准
- •post surgery bone fracture of the same limb
- •Pregnancy, lactation
- •active malignant tumor
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
时间窗: All patients who underwent surgery between 2014 to 2023
Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)
次要结局
- Ultrasound Assessment(All patients who underwent surgery between 2014 to 2023)
- Functional assessment: Goniometry(All patients who underwent surgery between 2014 to 2023)
- Short-Form 36 (SF-36)(All patients who underwent surgery between 2014 to 2023)
研究者
研究点 (1)
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