Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Kinematics and Cost-utility
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Michigan Hand Outcome Questionnaire
研究概览
简要总结
A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eaton-Glickel >2 arhritis
- •Symptom duration >3 months
- •Pain VAS >30mm
- •No significant comorbidities, ASA I-II
- •Fluent in Finnish language
排除标准
- •Eaton-Glickel <2
- •Duration of symptoms <3 months
- •VAS <30mm
- •Inflammatory joint disease
- •Systemic corticosteroid or immunomodulatory medication
- •Upper limb symptoms not explained with CMC I artritis
- •Heavy smoking (> 20 cigarettes per day)
- •Alcohol or drug abuse
- •Neurological condition affecting upper limb function
- •Other ipsilateral upper limb condition requiring surgery
研究组 & 干预措施
Trapeziectomy
Simple trapeziectomy for treating CMC I arthritis
干预措施: Trapeziectomy (Procedure)
Conservative
Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis
结局指标
主要结局
Michigan Hand Outcome Questionnaire
时间窗: 12 months
A hand-specific outcomes instrument that contains six distinct scales: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with hand function.
Patient-Rated Wrist Evaluation
时间窗: 12 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
次要结局
- Beck Depression Inventory(12 months)
- Cost-utility(12 months)
- Global improvemen(12 months)
- Pain Catastrophizing Scale(12 months)
- Pain (Visual Analogue Scale)(12 months)
- Grip strength(12 months)
- Wrist and hand (thumb) range of motion (ROM)(12 months)
- Carpal Kinematics(12 months)
研究者
Samuli Aspinen
Principal investigator
Töölö Hospital