Randomized Clinical Trial Comparing Two Surgical Techniques for the Treatment of Trigger Fingers: Longitudinal Opening Versus Complete A1 Pulley Release.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 236
- Primary Endpoint
- Compare trigger finger recurrences between longitudinal A1 pulley release surgery and complete A1 pulley resection surgery
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Persistence of pain to the operated finger(1 week, 4 weeks and one year after surgery)
- Range of motion of the operated finger(1 week, 4 weeks and one year after surgery)