Study of Open and Percutaneous Release of Acquired Trigger Thumb

Trigger Thumb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679793
• Other study ID #: Trigger thumb_Protocol_v02
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Trigger Finger Disorder
• Trigger Thumb

Intervention

Procedure:
• Open Release Group
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger
• Percutaneous Release Group
Percutaneous release is a minimal invasive alternative surgical procedure

Locations

Country	Name	City	State
Hong Kong	Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of local anaesthetics injected	The total volume of local anaesthetics injected during operation	Intra-operative
Primary	Duration of surgery (in minutes)	The time (in minutes) needed for operation	Intra-operative
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Satisfaction level after surgery	Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery	Post-op Day 7
Primary	Satisfaction level after surgery	Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery	Post-op Day 28
Primary	Satisfaction level after surgery	Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery	Post-op Day 91