Study of Open and Percutaneous Release of Acquired Trigger Thumb

The Chinese University of Hong Kong

Status: Completed

Conditions: Trigger Thumb

Treatments: Procedure: Open Release Group; Procedure: Percutaneous Release Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03679793

Trigger thumb_Protocol_v02

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Open Release Group

Active Comparator group

Description:

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

Treatment:

Procedure: Open Release Group

Percutaneous Release Group

Experimental group

Description:

Percutaneous release is a minimal invasive alternative surgical procedure

Treatment:

Procedure: Percutaneous Release Group