跳至主要内容
临床试验/NCT07101887
NCT07101887招募中不适用

Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.

Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2022年6月1日最近更新:

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

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)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Sponsor

研究点 (2)

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