Clinical trial NCT03679793: Study of Open and Percutaneous Release of Acquired Trigger Thumb
Official title: A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Thumb
Keywords: Trigger Finger Disorder
Trigger Thumb
Minimally Invasive Surgical Procedures
Orthopedics
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total volume of local anaesthetics injected
timeFrame: Intra-operative
measure: Duration of surgery (in minutes)
timeFrame: Intra-operative
measure: Surgical site pain
timeFrame: Intra-operative
measure: Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
timeFrame: Pre-operative
measure: Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
timeFrame: Post-op Day 7
measure: Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
timeFrame: Post-op Day 28
measure: Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
timeFrame: Post-op Day 90
measure: Pre-operative Kapandji score
timeFrame: Pre-operative
measure: Post-operative Kapandi score
timeFrame: Post-op Day 7
measure: Post-operative Kapandi score
timeFrame: Post-op Day 28
measure: Post-operative Kapandi score
timeFrame: Post-op Day 90
measure: Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
timeFrame: Pre-operative
measure: Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
timeFrame: Post-op Day 7
measure: Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
timeFrame: Post-op Day 28
measure: Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
timeFrame: Post-op Day 90
measure: Pre-operative pain at rest
timeFrame: Pre-opeartively
measure: Post-operative pain at rest
timeFrame: Post-op Day 7
measure: Post-operative pain at rest
timeFrame: Post-op Day 28
measure: Post-operative pain at rest
timeFrame: Post-op Day 90
measure: Pre-operative pain on exertion
timeFrame: Pre-operative
measure: Post-operative pain on exertion
timeFrame: Post-op Day 7
measure: Post-operative pain on exertion
timeFrame: Post-op Day 28
measure: Post-operative pain on exertion
timeFrame: Post-op Day 90
measure: Satisfaction level after surgery
timeFrame: Post-op Day 7
measure: Satisfaction level after surgery
timeFrame: Post-op Day 28
measure: Satisfaction level after surgery
timeFrame: Post-op Day 91
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
References: