Study of Open and Percutaneous Release of Acquired Trigger Thumb

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Trigger Thumb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Open Release Group

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

Group Type ACTIVE_COMPARATOR

Open Release Group

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Percutaneous Release Group

Intervention Type PROCEDURE

Percutaneous release is a minimal invasive alternative surgical procedure

Interventions

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Open Release Group

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

Intervention Type PROCEDURE

Percutaneous Release Group

Percutaneous release is a minimal invasive alternative surgical procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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)