Study of Open and Percutaneous Release of Acquired Trigger Thumb
A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 3, 2018
CompletedFirst Posted
Study publicly available on registry
September 20, 2018
CompletedSeptember 20, 2018
September 1, 2018
1.8 years
September 3, 2018
September 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (26)
Total volume of local anaesthetics injected
The total volume of local anaesthetics injected during operation
Intra-operative
Duration of surgery (in minutes)
The time (in minutes) needed for operation
Intra-operative
Surgical site pain
Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)
Intra-operative
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness
Pre-operative
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Post-op Day 7
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Post-op Day 28
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Post-op Day 90
Pre-operative Kapandji score
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
Post-operative Kapandi score
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-op Day 7
Post-operative Kapandi score
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-op Day 28
Post-operative Kapandi score
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-op Day 90
Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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-op Day 7
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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-op Day 28
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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-op Day 90
Pre-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Pre-opeartively
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-op Day 7
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-op Day 28
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-op Day 90
Pre-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Pre-operative
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-op Day 7
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-op Day 28
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-op Day 90
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Post-op Day 7
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Post-op Day 28
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Post-op Day 91
Study Arms (2)
Open Release Group
ACTIVE COMPARATOROpen surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.
Percutaneous Release Group
EXPERIMENTALPercutaneous release is a minimal invasive alternative surgical procedure
Interventions
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger
Percutaneous release is a minimal invasive alternative surgical procedure
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- With history in rheumatoid arthritis
- Unable to give verbal or written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Consultant and Clinical Associate Professor (Honorary)
Study Record Dates
First Submitted
September 3, 2018
First Posted
September 20, 2018
Study Start
August 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 20, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share
All collected data were from patients from study site and strictly confidential