NCT07497061

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 23, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

A1 pulley resectionsurgical technique for trigger fingerlongitudinal opening of the A1 pulley

Outcome Measures

Primary Outcomes (1)

  • Compare trigger finger recurrences between longitudinal A1 pulley release surgery and complete A1 pulley resection 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 Outcomes (2)

  • 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

Study Arms (2)

A1 pulley resection

EXPERIMENTAL

Complete resection

Procedure: Complete resection

longitudinal opening of the A1 pulley

ACTIVE COMPARATOR

Longitudinal incision

Procedure: Longitudinal incision

Interventions

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.

longitudinal opening of the A1 pulley

Fully removing the pulley in order to eliminate friction between the tendon and its fibrous band

A1 pulley resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring surgical intervention for the treatment of a trigger finger
  • Patients able to provide informed consent

You may not qualify if:

  • History of surgery for trigger finger correction on the same finger
  • Patients requiring simultaneous surgery for more than one trigger finger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Central Study Contacts

Johnny I Efanov, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

March 31, 2026

Record last verified: 2026-03