Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- patient assessment of the wrist
研究概览
简要总结
Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available.
The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.
详细描述
This is a two-center, randomized, prospective, comparative study.
The functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists.
The close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >45 years
- •Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)
- •Patient who has given his/her consent to participate in the study after being informed by the surgeon,
- •Patient living in France and able to answer the survey alone.
- •Subject affiliated to a social security system or beneficiary of such a system
- •No participation in any other clinical study
排除标准
- •Minor patient
- •Trapezium height < 8 mm
- •Major subject protected by law, under curatorship or guardianship
- •Known allergy to the materials of the medical device
- •Local infection
- •Local skin necrosis or unhealed wound
- •Pregnant or nursing women
研究组 & 干预措施
Control
Trapezectomy group
Experimental
Arthroplasty group
干预措施: HORUS (Device)
结局指标
主要结局
patient assessment of the wrist
时间窗: 4 weeks
Quick-Dash score (11 minimum value and 55 is maximum )
次要结局
- patient assessment of the wrist pain(4 weeks)