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Not Yet RecruitingNCT07497061

Comparison of Two Surgical Techniques for the Treatment of Trigger Fingers: Longitudinal Opening Versus Complete A1 Pulley Release

Randomized Clinical Trial Comparing Two Surgical Techniques for the Treatment of Trigger Fingers: Longitudinal Opening Versus Complete A1 Pulley Release.

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
236 (estimated)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Trigger finger is a pathology of the flexor tendons caused by inflammation of the tendon or its sheath, leading to pain, nodules, fibrosis, and limited mobility. Surgical treatment aims to release the space at the level of the A1 pulley, either through longitudinal opening (the standard technique, but associated with recurrence rates of approximately 7.7%) or through complete resection, an emerging approach that may reduce recurrences and the need for reoperations. However, comparative data remain limited, justifying further investigation. This project therefore aims to compare these two surgical techniques to determine which one results in the lowest recurrence rate and to assess their functional outcomes (pain, range of motion). The primary hypothesis is that A1 pulley resection reduces recurrences after one year, while the secondary hypothesis is that there is no significant difference in postoperative pain or mobility.

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELongitudinal incisionA 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.
PROCEDUREComplete resectionFully removing the pulley in order to eliminate friction between the tendon and its fibrous band

Timeline

Start date
2026-04-01
Primary completion
2029-04-01
Completion
2029-04-01
First posted
2026-03-27
Last updated
2026-03-31

Source: ClinicalTrials.gov record NCT07497061. Inclusion in this directory is not an endorsement.