Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 24
- 主要终点
- Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
研究概览
简要总结
Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Absence of carpal tunnel symptoms in the contralateral hand that interfere with normal daily activities or work at the time of consent and are not anticipated to interfere with return to activities or return to work within at least 3 months post-operatively
- •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 for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection)
- •Subject agrees to complete follow-up questionnaires over a 12-month period
- •Subject has a valid mobile phone number and 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 trigger finger that has clinically recovered
- •History of prior surgical CTR procedure in the target hand
- •History of prior surgical CTR in the contralateral hand within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
- •Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date
- •Presence of additional process in the target wrist or 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
- •Planned surgical or interventional procedure on the contralateral wrist or hand
- •Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
- •Amyloidosis
- •Chronic renal insufficiency requiring dialysis
- •Diabetes not controlled by a stable dose of medication over the past three months
- •Uncontrolled thyroid disease
- •Pregnant or planning pregnancy in the next 12 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
结局指标
主要结局
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
时间窗: 3 Month Follow-Up
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 scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change
时间窗: 3 Month Follow-Up
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
次要结局
未报告次要终点