A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post-operative Kapandi score
研究概览
简要总结
Trigger finger, also known as trigger digit or stenosing tenovaginitis, is caused by a size mismatch between the flexor tendon and the A1 pulley, which is generally characterized by pain, swelling, the limitation of finger range of motion and a symptomatic locking or clicking sensation. Conservative treatment options include the application of non-steroidal anti-inflammatory drugs (NSAID), physiotherapy, electrotherapy, splinting and corticosteroid injection but not always effective with regard to frequent recurrence. Open surgical release of the A1 pulley remains the gold standard of treating symptomatic trigger finger. While percutaneous release is a minimal invasive alternative and gaining popularity for the index, middle ring and little fingers, investigations for the surgical efficacy on thumb is few and far between. Investigators believe that a carefully conducted operation with proper positioning of the thumb, wide-awake approach and meticulous technique can achieve similar efficacy and safety in terms of possibly less intraoperative pain, imperceptible scar and early return to daily activities and routine work.
The hypothesis of this study is that by using a proper positioning of thumb, wide awake approach and meticulous technique in conducting percutaneous release of trigger thumb can achieve similar efficacy and safety compared to that of open release surgical method. Moreover, percutaneous release of trigger thumb can generate less intraoperative pain, imperceptible scar and promote early return to routine work.
Hence, the objective of this study is to investigate and compare the safety, effectiveness and outcome of percutaneous release versus traditional open release for trigger thumbs.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of trigger thumb with Green's staging graded 2-4
- •Patients were unresponsive to conservative treatments for more than 3 months (Nonsteroidal anti-inflammatory drugs, physiotherapy, splinting, or injection of steroid)
排除标准
- •With history in rheumatoid arthritis
- •Unable to give verbal or written consent.
研究组 & 干预措施
Open Release Group
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.
干预措施: Open Release Group (Procedure)
Percutaneous Release Group
Percutaneous release is a minimal invasive alternative surgical procedure
干预措施: Percutaneous Release Group (Procedure)
结局指标
主要结局
Post-operative Kapandi score
时间窗: Post-op Day 90
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Post-operative pain at rest
时间窗: Post-op Day 90
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Total volume of local anaesthetics injected
时间窗: Intra-operative
The total volume of local anaesthetics injected during operation
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
时间窗: Post-op Day 90
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Pre-operative pain at rest
时间窗: Pre-opeartively
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Duration of surgery (in minutes)
时间窗: Intra-operative
The time (in minutes) needed for operation
Surgical site pain
时间窗: Intra-operative
Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
时间窗: Post-op Day 90
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Pre-operative Kapandji score
时间窗: Pre-operative
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
时间窗: Pre-operative
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Pre-operative pain on exertion
时间窗: Pre-operative
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-operative pain on exertion
时间窗: Post-op Day 90
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Satisfaction level after surgery
时间窗: Post-op Day 91
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
时间窗: Pre-operative
Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
时间窗: Post-op Day 7
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
时间窗: Post-op Day 28
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Post-operative Kapandi score
时间窗: Post-op Day 7
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Post-operative Kapandi score
时间窗: Post-op Day 28
Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
时间窗: Post-op Day 7
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
时间窗: Post-op Day 28
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Post-operative pain at rest
时间窗: Post-op Day 7
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-operative pain at rest
时间窗: Post-op Day 28
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-operative pain on exertion
时间窗: Post-op Day 7
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-operative pain on exertion
时间窗: Post-op Day 28
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Satisfaction level after surgery
时间窗: Post-op Day 7
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Satisfaction level after surgery
时间窗: Post-op Day 28
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
次要结局
未报告次要终点
研究者
Dr TSE Wing Lim
Associate Consultant and Clinical Associate Professor (Honorary)
Chinese University of Hong Kong