Study of Open and Percutaneous Release of Acquired Trigger Thumb

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.

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

Conditions
-----------------
Trigger Thumb

Intervention / Treatment
-----------------
* Procedure: Open Release Group
* Procedure: Percutaneous Release Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Release Group<br>Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger. | Procedure: Open Release Group<br>* Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger<br>|
| Experimental: Percutaneous Release Group<br>Percutaneous release is a minimal invasive alternative surgical procedure | Procedure: Percutaneous Release Group<br>* Percutaneous release is a minimal invasive alternative surgical procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trigger Finger Disorder, Trigger Thumb, Minimally Invasive Surgical Procedures, Orthopedics