Study of Open and Percutaneous Release of Acquired Trigger Thumb

Not Applicable

Completed

• Conditions: Trigger Thumb
• Interventions: Procedure: Percutaneous Release Group; Procedure: Open Release Group

• Registration Number: NCT03679793
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-09
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-19
• Last Update Submitted: 2018-09-19
• Study First Posted: 2018-09-20
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Release Group	Percutaneous Release Group	Percutaneous release is a minimal invasive alternative surgical procedure
Open Release Group	Open Release Group	Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.

Primary Outcome Measures

Name	Time	Method
Post-operative Kapandi score	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	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	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	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	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)	Intra-operative	The time (in minutes) needed for operation
Surgical site pain	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)	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	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	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	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	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	Post-op Day 91	Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong