Registry of the Patient Experience for Carpal Tunnel Release (MISSION)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,424
- 试验地点
- 98
- 主要终点
- Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
研究概览
简要总结
Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).
详细描述
Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •≥18 years of age
- •Clinical diagnosis of unilateral or bilateral CTS
- •A clinical decision has been made to perform CTR on one or both hands
- •CTS-6 score ≥12 in the target hand(s)*
- •Confirmatory diagnostic testing in the target hand(s)*:
- •CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
- •ECTR or OCTR: Confirmatory electrodiagnostic testing
- •Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s)
- •Patient agrees to complete follow-up questionnaires over a 24-month period
- •Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires
- •Note: An asterisk (*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.
排除标准
- •Patient meets any of the contraindications per Instruction For Use (IFU)
- •Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
研究组 & 干预措施
Endoscopic Carpal Tunnel Release (ECTR)
Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR)
干预措施: Endocscopic CTR (Procedure)
Ultrasound Guided Carpal Tunnel Release (CTR-US)
Carpal Tunnel Release using CTR-US technique
干预措施: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US) (Device)
Open Carpal Tunnel Release (OCTR)
Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR)
干预措施: Open CTR (Procedure)
结局指标
主要结局
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
时间窗: 24 Months
Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The change in BCTQ-SSS score at the 24-month follow-up relative to baseline.
次要结局
- Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)(24 Months)
- Numeric Pain Scale(24 Months)
- EuroQoL 5-Dimension 5-Level (EQ-5D-5L)(24 Months)
- Device and/or Procedure Related Adverse Events(24 Months)
- Global Satisfaction with Carpal Tunnel Release Procedure(24 Months)