NCT07169474
招募中
不适用
Treatment of Peri-trapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty
Clinique Saint Jean, France1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年9月9日最近更新:
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Clinique Saint Jean, France
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score
概览
简要总结
The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms.
The primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively.
The study design is a follow-up study of a multicenter cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Patients over 18 years of age who are members or beneficiaries of french social security
- •Patient requiring surgical management
- •Clinical and radiographic diagnosis of peri-trapezial osteoarthritis in the 1 or 2 joints:
- •TM osteoarthritis: glickel sign + grinding test STT osteoarthritis: pain on wrist mobilization in flexion-extension and prono-supination
- •TM (Eaton-Littler stages II to III) and STT (Crosby stages II and III) radiographic osteoarthritis
- •Persistent pain and functional limitations despite conservative treatment for at least 6 months (combining intermittent immobilization of wrist and thumb + joint infiltration of the 2 joints)
- •Ability to understand and sign the informed consent form.
排除标准
- •History of surgery on the affected thumb.
- •Systemic inflammatory diseases (e.g. rheumatoid arthritis).
- •Active infection or history of joint infection of the upper limb.
- •Inability to participate in post-operative follow-up.
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score
时间窗: One year
Change in Quick DASH functional score between inclusion (preoperative) and one year postoperatively, from 0 = no disability to 100 = maximum disability.
次要结局
- Patient satisfaction(3 months, 6 months and 12 months post-operative)
- Complication or surgery(One year)
- Radiographic evaluation(one year)
- Pain in the operated hand(3 months, 6 months and 12 months postoperatively)
- Pinch and grip force(3 months, 6 months and 12 months postoperatively)
- Range of motion of the thumb(3 months, 6 months and 12 months postoperatively)
- Wrist range of motion(3 months, 6 months and 12 months postoperatively)
- Amplitude of possible metacarpophalangeal hyperextension(preoperatively at 3 months, 6 months and 12 months postoperatively)
研究者
Benjamin DEGEORGE
Surgeon
Clinique Saint Jean, France
研究点 (1)
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