Carpal Tunnel Release Using Ultrasound Patient Experience Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months
研究概览
简要总结
The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.
详细描述
The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.
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
- 是
入选标准
- •Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance
- •18 years of age or older
- •Agree to complete questionnaires over a 12-month period
- •Valid mobile phone number and email address to receive and answer questions
排除标准
- •Age less than 18 years
结局指标
主要结局
Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months
时间窗: 12 months
To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale. The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function.
Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months
时间窗: 12 months
To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months. The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function.
次要结局
- Patient reported time to return to activities(Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months)