Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- VAS
研究概览
简要总结
It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rizarthrosis grade I, II, III
排除标准
- •Rizarthrosis grade IV
- •Severe osteoporosis
- •Metals allergy
- •Previous surgical interventions related
- •Malformations in the articular zones that difficult the implant placement
结局指标
主要结局
VAS
时间窗: 1 year
Pain evaluated by Visual analogic scale (VAS)
Quick Dash
时间窗: 1 year
Function of the arm evaluated by Quick Dash scale
次要结局
- Strength(1 year)
