- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07497061
Comparison of Two Surgical Techniques for the Treatment of Trigger Fingers: Longitudinal Opening Versus Complete A1 Pulley Release (TRIGGER)
Randomized Clinical Trial Comparing Two Surgical Techniques for the Treatment of Trigger Fingers: Longitudinal Opening Versus Complete A1 Pulley Release.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Trigger finger can affect any finger of the hand, but most commonly involves the third and fourth digits. Trigger finger is a disorder of the flexor tendons, which are responsible for finger flexion. The condition occurs when inflammation develops either in the tendon or in its sheath. The exact cause of this inflammation is often difficult to determine, but it may result from a previous injury or repetitive finger use. If the inflammation is not treated, the finger may loose mobility in flexion or become locked in a flexed position, causing significant pain. Some individuals develop nodules at the base of the affected fingers, while in others the sheath becomes fibrotic or narrowed, reflecting the formation of scar tissue. This leads to friction between the tendon and the A1 pulley (a portion of the sheath) during finger movement, causing pain and impaired mobility.
Longitudinal opening of the A1 pulley and complete A1 pulley resection are two surgical procedures described for the treatment of trigger finger. In both cases, the goal of surgery is to create more space so that the inflamed tendon can glide smoothly within the tendon sheath without friction. Longitudinal opening consists of making a longitudinal incision in the A1 pulley with a scalpel. Resection, or excision, involves completely removing the A1 pulley.
Longitudinal opening of the A1 pulley is the current standard of care performed by most surgeons for trigger fingers that do not respond to conservative measures. Reported success rates range from 90% to 100% across patient populations. However, the literature suggests that recurrence after longitudinal release is one of the main adverse outcomes, with a documented rate of approximately 7.7% according to several studies. Conversely, complete A1 pulley excision is an innovative technique that appears promising. A retrospective study by Porter et al. suggested a potential advantage of this approach, including reduced need for postoperative injections and fewer revision surgeries.These findings indicate a possible benefit of complete resection in preventing recurrence, particularly in diabetic patients. However, as a retrospective study, it carries important methodological limitations. A randomized clinical trial is currently underway to more rigorously evaluate this approach and validate its effectiveness on a larger scale, but no data are yet available. In this context, additional data from diverse clinical settings are essential.
The objective of this clinical trial is to compare longitudinal opening of the A1 pulley with complete A1 pulley resection in patients with at least one trigger finger. This will help confirm the findings of Porter et al.'s retrospective study while contributing to external validation of the technique. The primary aim is to determine which surgical technique results in the lowest recurrence rate. The secondary aim is to compare functional outcomes such as pain and range of motion.
The primary hypothesis is that A1 pulley resection will lead to fewer trigger finger recurrences after one year compared with longitudinal opening of the A1 pulley. The secondary hypothesis is that there will be no significant difference in postoperative pain or finger mobility between the two techniques.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johnny I Efanov, MD, PhD
- Phone Number: 23757 514-890-8000
- Email: ionut.efanov.med@ssss.gouv.qc.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients requiring surgical intervention for the treatment of a trigger finger
- Patients able to provide informed consent
Exclusion Criteria:
- History of surgery for trigger finger correction on the same finger
- Patients requiring simultaneous surgery for more than one trigger finger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A1 pulley resection
Complete resection
|
Fully removing the pulley in order to eliminate friction between the tendon and its fibrous band
|
|
Active Comparator: longitudinal opening of the A1 pulley
Longitudinal incision
|
A longitudinal incision of the A1 pulley performed to open the pulley, thereby reducing the pressure on the inflamed tendon and facilitating its gliding during finger movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare trigger finger recurrences between longitudinal A1 pulley release surgery and complete A1 pulley resection surgery
Time Frame: One year after surgery
|
The diagnostic method will be clinical evaluation.
It will be based on the patient's clinical history, including the presence of a painful 'click' during finger movement, a finger that occasionally locks in flexion, pain over the A1 pulley, and/or a palpable nodule at the level of the A1 pulley.
The primary outcome will be assessed by an independent, blinded evaluator who did not participate in the surgery and is unaware of the patient's allocation.
If necessary, the evaluator will verify the limitation by placing the dorsal surface of the patient's hand on the table and asking the patient to make a fist (flexion) and then open the hand (extension): the inability of the affected finger to remain in a flexed position will confirm the diagnosis.
No score, tool, or scale is required for diagnosis, as recurrence is a binary variable that is either present or absent.
|
One year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Persistence of pain to the operated finger
Time Frame: 1 week, 4 weeks and one year after surgery
|
Pain will be measured using the Visual Analog Scale (VAS), which consists of a 10-cm linear paper scale with a horizontal line labeled only at both ends: '0 = no pain' and '10 = worst imaginable pain.'
After the patient marks their pain level by placing a point on the line, the distance in millimeters will be measured with a ruler by the blinded evaluator.
All evaluators will follow the same procedure to ensure inter-observer consistency."
|
1 week, 4 weeks and one year after surgery
|
|
Range of motion of the operated finger
Time Frame: 1 week, 4 weeks and one year after surgery
|
The measurement tool for range of motion will be a goniometer, an instrument that allows precise measurement of the finger's flexion and extension angles.
|
1 week, 4 weeks and one year after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-13176
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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