Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Implant survival
研究概览
简要总结
The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.
详细描述
The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Eaton type 2+3 TMC osteoarthritis
排除标准
- •Patients with Eaton type 4 TMC osteoarthritis
研究组 & 干预措施
Patient cohort
TMC total joint arthroplasty
干预措施: Total joint arthroplasty (Procedure)
结局指标
主要结局
Implant survival
时间窗: 10 year survival
Revision with removal of implant
次要结局
未报告次要终点
研究者
Torben B. Hansen
Professor, MD, PhD
Regional Hospital Holstebro