NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maximum active postoperative MP flexion
研究概览
简要总结
The main hypotheses for this study are as follows:
- The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is at least 10 degrees greater than with teh use of the Swanson implant.
- The use of the NeuFlex implant is associated with a significantly (2.5 kg or more) greater grip strength than with the use of the Swanson implant.
详细描述
Many studies have evaluated metacarpophalangeal joint (MP) range of motion following Swanson arthroplasty. These studies report that overall MP flexion is restricted postoperatively. They do not usually report individual range of motion values for each digit. Therefore one cannot identify if the degree of MP flexion restriction differs by digit.
We, and others, have observed that MP flexion is particularly restricted in the ring and litter finger following Swanson arthroplasty.
There is a new implant (NeuFlex), which instead of being introduced in full extension, like the Swanson implant, has a resting position of 30 degrees of flexion. As MP flexion is particularly restricted in the ring and little finger, an implant that by design encourages flexion may be helpful. A need exists to establish if the use of the NeuFlex implant produces greater MP flexion in the ring and little finger where restricted flexion has been identified as a problem.
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
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rheumatoid arthritis
- •primary metacarpophalangeal arthroplasty of all 4 digits
排除标准
- •diagnosis of other connective tissue disorder (e.g. SLE, MCTD)
- •previous surgery of MP joints
- •revision metacarpophalangeal arthroplasty
结局指标
主要结局
Maximum active postoperative MP flexion
次要结局
- Sollerman Hand Function Score
- Jamar grip strength
- Michigan Hand Questionnaire
- Maximum active postoperative MP extension
- Maximum active postoperative MP arc of motion
- Ulnar drift
