Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release: A Prospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Activities of Daily Living (Study-specific questionnaire)
研究概览
简要总结
Clinical outcomes after open trigger finger release are excellent. Minimally invasive techiques with ultrasound guidance theoretically offer advantages for faster recovery but this technique has not been compared prospectively with the standard of care (open trigger release). This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.
详细描述
Trigger finger is initially treated conservatively. Conservative treatment options include modification of activities, painkiller administration, splinting, and corticosteroid injections (1). Open or minimally invasive surgical treatment can be considered if conservative treatment fails. Minimally invasive surgery options consist of ultrasound-guided or blind percutaneous trigger finger release.
Many studies have reported good clinical outcomes after ultrasound-guided trigger finger release, including low rates of catching or locking recurrence rates, high QuickDASH scores and high patient satisfaction (2-4).
Postoperative clinical outcomes of open surgery have been widely compared to percutaneous surgery (5-8). However, the comparison of postoperative results between ultrasound-guided and open trigger finger release has been scarcely reported. Nikolaou et al. reported that ultrasound-guided trigger finger release resulted in a significantly sooner return to normal activities and better patient-reported cosmetic outcomes than open trigger finger release (9). Success rates and mean QuickDASH scores did not differ significantly between these groups in this cohort.
The potential benefits of ultrasound-guided trigger finger release compared to open trigger finger release have yet to be investigated. This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.
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
- 否
入选标准
- •undergoing trigger finger release for the index through small fingers due to symptoms refractory to conservative treatment and elected for surgical intervention through shared decision-making
- •English-speaking adults (≥18 years of age)
- •Patients with inflammatory arthritis were included if their diagnosis had been established ≥5 years prior without exacerbations in the past 5 years. Those on immunomodulatory therapy were required to have been on a stable regimen for ≥5 years without flare-ups.
排除标准
- •prior surgery on the affected finger
- •corticosteroid injection in the affected hand within 6 weeks
- •additional hand or wrist pathology requiring concurrent surgery
- •symptomatic trigger finger in the contralateral extremity
- •prior surgical pulley release in either hand within 6 months of enrollment
- •Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus) not controlled
- •inflammatory arthritis if diagnosis established <5 years, exacerbation within the past 5 years, or modifications to immunomodulatory therapy within 5 years of enrollment
- •Amyloidosis
- •Diabetes not controlled by a stable dose of medication over the past three months
- •Pregnant or planning pregnancy in the next 6 months
- •Workers' compensation subjects
- •Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements, including patients who do not speak English
- •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.
- •Trigger Thumb
研究组 & 干预措施
Open Release
Patients who underwent open trigger finger release
Ultrasound-Guided Release
Patients who underwent ultrasound-guided trigger finger release
干预措施: UltraGuideTFR (Sonex Health, MN, USA) (Device)
结局指标
主要结局
Activities of Daily Living (Study-specific questionnaire)
时间窗: From enrollment to final follow-up at 6 months
Study-specific survey of limitations with Activities of Daily Living. Responses for questions on the study-specific survey for limitations with ADLS utilized a Likert scale with 1 representing no difficulty with the task and 5 being unable to perform the task due to limitations from trigger finger symptoms. Likert scale responses for the 12 ADLs on the survey were summated for final scores ranging from 14 (no difficulty with any ADLs) to 70 (unable to perform any ADLs). These were standardized to a 100-point scale to facilitate clinical interpretation of outcomes. A score of 0 represented no functional limitations with ADLs and a score of 100 represented inability to perform any ADL on the survey.
Pain on the Visual Analogue Scale
时间窗: From enrollment to final follow-up at 6 months
VAS pain score on a scale from 1 to 10 with a score of 1 representating no pain and score or 10 representing maximal pain.
次要结局
- Timing of Return to work(From 2 days post-procedure to final follow-up at 6 months)
- Patient satisfaction with procedure(Single evaluation at final follow-up 6 months post-procedure)
研究者
Rohit Garg
Director, Hand Surgery Fellowship Program, Assistant Professor of Orthopedic Surgery
Massachusetts General Hospital