Prospective Randomized Trial Comparing Longitudinal vs. Transverse A1 Pulley Release

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Washington University School of Medicine
Study ID
NCT07516652
Status
Recruiting

Conditions

  • Stenosing Tenosynovitis
  • Trigger Finger

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Open A1 Pulley Release — PROCEDURE
    Surgical release of the first annular (A1) pulley to treat stenosing tenosynovitis (trigger finger). Participants receive either a longitudinal or transverse incision based on their randomized arm assignment. All other aspects of surgical technique and post-operative care are standardized.

Study Details

The goal of this clinical trial is to compare two different skin incisions used in surgery to treat trigger finger in adult patients. Trigger finger occurs when a finger gets stuck or locks because of swelling of the sheath around the tendons the help move the fingers. The main questions it aims to answer are (1) Does the type of skin cut affect how well the hand works 6 weeks after surgery? (2) Does the type of skin cut affect pain levels, scar healing, and how quickly people return to their normal activities? Orthopaedic surgeons will compare a straight incision along the finger (longitudinal incision) to a incision across the crease in the palm (transverse incision) to see if one type of incision results in better recovery, less pain, a better scar, and higher patient satisfaction with the procedure. Participants who have trigger finger and are indicated for surgery will have surgery to release the pulley in their finger using one of the two types of incisions (assigned by chance). Participants will fill out questionnaires about their hand function and pain before surgery and at follow-up visits. Participants will have their scar checked and rated at about 2, 6, and 12 weeks after surgery, and report on their pain for the first few days after surgery and when they can return to work and move their finger without pain.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Apr 1, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Longitudinal Incision
    Participants randomized to this arm will undergo standard open A1 pulley release for trigger finger using a longitudinal incision along the axis of the finger.
  • Experimental: Transverse Incision
    Participants randomized to this arm will undergo standard open A1 pulley release for trigger finger using a transverse incision placed in the distal palmar crease.

Primary Outcome Measure

PROMIS Upper Extremity Score [ Time Frame: Approximately 6 weeks post-operatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Chicago MedicineChicagoIllinois60537
Jennifer Wolf, MD
773-834-3531
Oluwafemi Afolabi, Administrative Specialist
773-702-6254
Jennifer Wolf, MD (PRINCIPAL_INVESTIGATOR)
Washington University and Barnes-Jewish Orthopedic CenterSt LouisMissouri63110
Alli Rittenhouse
(314) 747-2652
Matthew Berning
(314) 514-3500
Jason Strelzow, MD (PRINCIPAL_INVESTIGATOR)
Ryan Calfee, MD (SUB_INVESTIGATOR)
Nisha N Kale, MD (SUB_INVESTIGATOR)

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