A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Post-operative Kapandi score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •With history in rheumatoid arthritis
- •Unable to give verbal or written consent.
Arms & Interventions
Open Release Group
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.
Intervention: Open Release Group (Procedure)
Percutaneous Release Group
Percutaneous release is a minimal invasive alternative surgical procedure
Intervention: Percutaneous Release Group (Procedure)
Outcomes
Primary Outcomes
Post-operative Kapandi score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: Intra-operative
The time (in minutes) needed for operation
Surgical site pain
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Post-op Day 7
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Satisfaction level after surgery
Time Frame: Post-op Day 28
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr TSE Wing Lim
Associate Consultant and Clinical Associate Professor (Honorary)
Chinese University of Hong Kong