Efficacy and Safety of the Touch® Dual Mobility Trapeziometacarpal Prosthesis and Its Surgical Instruments Set in the Treatment of Basal Thumb Osteoarthritis: Post-market Observational Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
- 试验地点
- 6
- 主要终点
- Mobility and pain
研究概览
简要总结
Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.
The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck).
The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force.
Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (age ≥ 18 years),
- •Patients suffering from rhizarthrosis (I - IV based on the Dell classification),
- •Pain >3 on the VAS scale,
- •Patients to undergo a replacement of the trapeziometacarpal joint with the Touch® dual mobility trapeziometacarpal prosthesis.
排除标准
- •Pregnant women,
- •Patients with contraindications to surgery in general,
- •Patients suffering from Temporary Regional Pain Syndrome (TRPS),
- •Patients with a severe or chronic, local or systemic infection,
- •Patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint,
- •Patients with bone demineralization or destruction that may affect the proper fixation of the implant,
- •Patients whose bone dimensions are incompatible with the implant dimensions,
- •The combination of the Touch® prosthesis with other components of another origin is not authorized,
- •Patients with allergies to the components of the product or with known allergies (chromium, cobalt, nickel),
- •Patients with an intellectual disability who cannot, therefore, follow the instructions of their surgeon,
- •Patient with scaphoid-trapezium-trapezoid (STT) arthritis,
- •Patient requiring revision of a trapeziometacarpal prosthesis,
- •Patient who has undergone a TMC joint infiltration within 3 months of the expected date of replacement of the joint with a Touch® prosthesis.
结局指标
主要结局
Mobility and pain
时间窗: 3 months
At 3 months post-surgery, the proportion of patients with a Kapandji score \> 8 and a pain score ≤ 3 on a VAS scale.
次要结局
未报告次要终点