Short-term Recovery After Trapeziectomy and TMC Prosthesis: a Diary Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Rationale: The trapeziometacarpal (TMC) joint is one of the most common areas in the hand and wrist to develop osteoarthritis (OA). Currently, the two most widely used procedures are the trapeziectomy and the TMC-joint arthroplasty, both with their own pros and cons. No studies have demonstrated superiority of TMC-joint arthroplasty over gold-standard trapeziectomy. And no clinical studies show short-term recovery and patient experience after trapeziectomy or TMC-joint arthroplasty.
Objective: To gather insight in short-term recovery and patient experience after a trapeziectomy or TMC prosthesis regarding pain, pain medication, function and quality of life.
Study design: A prospective observational cohort diary study.
Study population: In total 200 subjects with TMC-joint osteoarthritis will participate: 100 subjects will have trapeziectomy and 100 subjects will have TMC-joint arthroplasty
Main study parameters/endpoints: The main study parameters are the pain, function and quality of life during the first 8 weeks after surgery.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will have no direct benefit from participation in this study. Subjects will only complete a diary and questionnaires for this study. Therefore, we expect no risks from participation. The burden for subjects consists of approximately five minutes daily for the diary in the first eight weeks after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Failed conservative treatment for osteoarthritis
- •Planned for trapeziectomy or TMC-joint arthroplasty
- •Age 18-75 years
- •Willing and able to comply with the postoperative functional assessment and to participate in a rehabilitation schedule
排除标准
- •Mentally disabled patients
- •Active infection
- •Current malignancy
- •Infiltration (corticoids < 3 months)
- •The following criteria is specific for the TMC-joint arthroplasty group and is an addition to the criteria mentioned above:
- •Trapezium height < 8 mm
结局指标
主要结局
Pain
时间窗: 8 weeks
Pain will be measured each day in a diary for the first 8 weeks after surgery with the Numeric Rating Scale for Pain (NRS), which is a scale ranging from zero to ten on which patients can score their pain. It is a widely used instrument in varying populations due to its ease of administration and clinical relevance to the subject.
Function
时间窗: 8 weeks
Function will be measured each week in a diary for the first 8 weeks after surgery with the The Patient-Related Wrist/Hand Evaluation (PRWHE), which is a 15-item questionnaire concerning pain and function. Subjects are able to rate their pain and disabilities from zero to ten.
Quality of life (QoL)
时间窗: 8 weeks
QoL will be measured twice a week in a diary for the first 8 weeks after surgery with the EQ-5D, which is a general health-related quality-of-life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality of life adjusted life years (QALY).
次要结局
- Complications(1 year)
- Pain medication(8 weeks)
- PROMs - NRS(1 year)
- PROMs - PRWHE(1 year)
- PROMs - EQ5D(1 year)
- PROMs - HADS(1 year)