Patient Satisfaction for Post-Operative Carpometacarpal Arthroplasty: Wood Casting Versus Thermoplastic Splint
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Patient Satisfaction Score
研究概览
简要总结
This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.
详细描述
Patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.
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
- 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
- •Patients over the age of 18 years old.
- •Intact Medical Decision Making
- •Eligible for Surgical Intervention
- •Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks
排除标准
- •Pregnant Women
- •Deemed Unsuitable by Principal Investigator
研究组 & 干预措施
Woodcasting Splint
Woodcasting is an already FDA approved on the market product that is not used a lot so for the purpose of the study we would like to show superior outcomes.
干预措施: Woodcasting Splint (Other)
Thermoplastic Splint
Thermoplastic splints is an FDA approved on the market orthrosis that is used by Occupational Therapists which is standard of care for patients that undergo CMC arthroplasty.
干预措施: Control (Standard treatment) (Other)
结局指标
主要结局
Patient Satisfaction Score
时间窗: 6 Weeks
The satisfaction survey consists of three questions totaling 15. The minimum value is a 1, while the maximum value is 15. A higher score indicating highest satisfaction.
次要结局
- Waste(2 Weeks)
- Splint Satisfaction(6 Weeks)
- Splint Issues(6 Weeks)
研究者
Michael C. Doarn
Principal Investigator
Foundation for Orthopaedic Research and Education