Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results: An Ambidirectional Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Patient satisfaction wiht treatment result using 5-point Likert scale
研究概览
简要总结
The study aims to determine whether CMC I arthroplasty using a Touch® implant results in higher patient satisfaction compared to RSI arthroplasty in the medium-term in patients with primary thumb osteoarthritis. Additionally, the study compares the patients' clinical and self-reported outcomes between the Touch® implant and the RSI arthroplasty. Therefore, patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb will be recruited.
详细描述
Patients suffering from osteoarthritis in the first carpometacarpal joint (CMC I OA) are often surgically treated with a resection-suspension-interposition (RSI) arthroplasty. An alternative technique is an arthroplasty with a Touch® implant. There is a growing body of evidence indicating that patients with a Touch® prosthesis recover significantly faster and return to work more quickly than patients after an RSI arthroplasty. However, there have been no studies comparing the two operations in the same patient. By recruiting patients with a Touch® implant in one thumb and an RSI arthroplasty in the other thumb, this study aims to investigate whether CMC I arthroplasty using a Touch® implant leads to higher patient satisfaction compared to RSI arthroplasty in the medium-term. Further patient-reported and clinical outcomes will be assessed to compare the two surgeries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Informed Consent signed by the patient.
- •Patient is diagnosed with primary OA in both CMC I joints and was operated with a Touch® prosthesis on one thumb and with an RSI arthroplasty on the other thumb.
排除标准
- •Patient with any type of revision surgery at the CMC I joint
- •Patient underwent hand surgery within the last three months
- •Legal incompetence
结局指标
主要结局
Patient satisfaction wiht treatment result using 5-point Likert scale
时间窗: Follow-up at least 3 months to 12 years after surgery
5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied)
次要结局
- Pain at rest and during activities of daily living (ADL) assessed using Numeric rating scales (NRS)(Follow-up at least 3 months to 12 years after surgery)
- Key pinch strength assessed with pinch gauge(Follow-up at least 3 months to 12 years after surgery)
- Brief Michigan Hand Outcomes Questionnaire (MHQ)(Follow-up at least 3 months to 12 years after surgery)
- Differences between both thumbs(Follow-up at least 3 months to 12 years after surgery)
- Grip strength assessed with Jamar Dynamometer(Follow-up at least 3 months to 12 years after surgery)
- Additional aspects of patient satisfaction with treatment(Follow-up at least 3 months to 12 years after surgery)
- Sociodemographic information(Follow-up at least 3 months to 12 years after surgery)
- Range of motion of the humb metacarpal (MCP) and interphalangeal (IP) joint assessed with a goniometer(Follow-up at least 3 months to 12 years after surgery)
- Radiographs of both thumbs(Follow-up at least 3 months to 12 years after surgery)