Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 12
- 主要终点
- Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
研究概览
简要总结
Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.
详细描述
Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting reporting the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥18 years of age
- •Clinical diagnosis of unilateral or bilateral idiopathic CTS
- •CTS-6 score >12 in target hand*
- •Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound*
- •Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)*
- •Subject agrees to complete follow-up questionnaires over a 24-month period
- •Subject has a valid smart phone number and/or email address to receive and answer follow-up questionnaires
排除标准
- •Prior surgery on the target wrist or hand with the exception of (a) trigger finger release or similar minor finger procedure (e.g., digital ganglion cyst removal, foreign body removal) that has clinically recovered, or release for DeQuervain's syndrome (1st dorsal compartment) that has clinically recovered*
- •History of prior surgical CTR in the target hand*
- •History of infection in the target hand*
- •History of prior surgery in the non-target hand, including CTR, within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
- •Planned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date*
- •Corticosteroid injection in the target hand within 6 weeks of study procedure date*
- •Presence of additional process in the target hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)*
- •Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side*
- •Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side*
- •Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side*
- •Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side*
- •Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side*
- •Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
- •Amyloidosis
- •Chronic renal insufficiency requiring dialysis
- •Diabetes not controlled by a stable dose of medication
- •Uncontrolled thyroid disease
- •Pregnant or planning pregnancy in the next 24 months
- •Workers' compensation subjects
- •Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
- •Subject has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations
- •Note: An asterisk (*) denotes that this criterion must be applied to the target hand for unilateral CTR-US procedures, or to both hands for simultaneous bilateral CTR-US procedures.
- •Clinically significant is defined as likely to interfere with the performance of the procedure in a safe and/or effective manner.
结局指标
主要结局
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
时间窗: Baseline and 3 Months
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). 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 mean change score in BCTQ-SSS from baseline and 3-month follow-up are reported. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. Bilateral patients with both hands treated are reported based on their averaged score.
次要结局
- Time to Return To Normal Daily Activities (RTA)(3 Months)
- Time to Return To Work Among Employed Subjects (RTW)(3 Months)
- Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)(Baseline and 3 Months)
- Michigan Hand Questionnaire (MHQ)(Baseline and 3 Months)
- Numeric Pain Scale(Baseline and 3 Months)
- EuroQoL 5-Dimension 5-Level (EQ-5D-5L)(Baseline and 3 Months)
- Number of Participants With Device and/or Procedure Related Adverse Events(3 Months)
- Global Satisfaction(3 Months)