Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- quick-DASH
研究概览
简要总结
Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.
详细描述
Eligible: patients >18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis.
Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy
Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength
Complications are registered.
The patients are observed for two years and the investigators aim to include a total of 40 patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CMC 1 arthritis
- •Pain and dysfunction
- •Adult patients
- •General good health
排除标准
- •Pregnancy
- •STT arthritis (CT scan preoperatively for all patients)
- •Other injuries in thumb/hand
研究组 & 干预措施
Trapeziektomi and ligament interposition
Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)
干预措施: Interpositional arthroplasty (Burton-Pellegrini procedure) (Procedure)
Total joint replacement
Elektra CMC1 uncemented prosthesis Elektra prosthesis
干预措施: Total joint replacement (Procedure)
Total joint replacement
Elektra CMC1 uncemented prosthesis Elektra prosthesis
干预措施: Elektra prosthesis (Device)
结局指标
主要结局
quick-DASH
时间窗: Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.
two-page questionnaire with VAS-scale for pain and function.
次要结局
- Nelson hospital score(Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.)
研究者
Rasmus Thorkildsen
Senior Consultant
Oslo University Hospital