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Study of Open and Percutaneous Release of Acquired Trigger Thumb

A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03679793
Enrollment
30
Registered
2018-09-20
Start date
2013-08-31
Completion date
2015-06-30
Last updated
2018-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigger Thumb

Keywords

Trigger Finger Disorder, Trigger Thumb, Minimally Invasive Surgical Procedures, Orthopedics

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.

Interventions

PROCEDUREOpen Release Group

Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger

PROCEDUREPercutaneous Release Group

Percutaneous release is a minimal invasive alternative surgical procedure

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Total volume of local anaesthetics injectedIntra-operativeThe total volume of local anaesthetics injected during operation
Duration of surgery (in minutes)Intra-operativeThe time (in minutes) needed for operation
Surgical site painIntra-operativeVisual 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)Pre-operativePre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness
Pre-operative Kapandji scorePre-operativeKapandji 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 scorePost-op Day 7Kapandji 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 workPre-operativeThe 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 workPost-op Day 7The 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 restPre-opeartivelyVisual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-operative pain at restPost-op Day 7Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Pre-operative pain on exertionPre-operativeVisual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-operative pain on exertionPost-op Day 7Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Satisfaction level after surgeryPost-op Day 7Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026