Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- revision rate
研究概览
简要总结
Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty. Several implants are available on the market and they all have different pros and cons. One risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose, revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the likely alternative. Revision rates five years after the index operation have improved, however, they cannot yet compare with the results after a total hip arthroplasty. A newly designed TWA has been developed by the department of Hand Surgery, Örebro university Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers theoretical advantages and has been biomechanically tested at the Mayo clinic.
This is a pilot study where patients operated with the TWA will be assessed pre and postoperatively according to study protocol in order to evaluate outcome after TWA radiologically, clinically and regarding patient perceived outcome measures.
详细描述
Method: Patients will be studied preoperatively and after 1, 2, 5, and 10 years with respect to changes of the following outcome measures.
- Patient related outcome measures: DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation.
- Wrist range of motion: dorsal/volar flexion, ulnar/radial deviation, pronation/supination. Hand grip strength, pinch grip, key pinch.
- Wrist pain. VAS-pain scores (Visual analog score) at rest and in activity.
- X-ray findings. Implant survival will be studied with Kaplan-Meyer graphs.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful wrist arthritis
- •Wrightington X-ray grade 2-4.
排除标准
- •Infection
- •Substance abuse
- •Mental illness.
研究组 & 干预措施
total wrist arthroplasty, Trimed
This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty.
干预措施: total wrist arthroplasty, Trimed (Device)
结局指标
主要结局
revision rate
时间窗: changes in revision rates up to 10 years postoperatively
The frequency of TWA implants revised up to 10 years after the index operation
次要结局
- Changes in Range of Motion (ROM(1, 2, 5, and 10 years postoperatively)
- changes in patient related outcome measures (PROM)(1, 2, 5, and 10 years postoperatively)
研究者
Anil Gupta
dr Anil Gupta, MD, FRCA, PhD
Örebro University, Sweden