Prospective Randomized Trial Comparing Longitudinal vs. Transverse A1 Pulley Release

March 31, 2026 updated by: Jason Strelzow, Washington University School of Medicine

Incision Decision: A Prospective Randomized Trial Comparing Longitudinal vs. Transverse A1 Pulley Release Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, randomized controlled trial comparing clinical and patient-reported outcomes between longitudinal and transverse incisions for open A1 pulley release in the treatment of idiopathic trigger finger (stenosing tenosynovitis of the fingers, excluding the thumb). Stenosing tenosynovitis of the flexor tendon, commonly known as trigger finger, is a frequent hand condition with a lifetime incidence of approximately 2.6%. It results from inflammation and a size mismatch between the flexor tendon and the first annular (A1) pulley, leading to painful catching, clicking, or locking during finger flexion and extension. When conservative measures such as splinting and corticosteroid injections fail, surgical release of the A1 pulley is indicated. Although A1 pulley release is one of the most commonly performed hand procedures and is generally considered safe and effective, reported complication rates range from 6% to 36% and include wound-healing issues, persistent or recurrent triggering, infection, wound dehiscence, and painful scar formation. Patient dissatisfaction is most often related to scar tenderness, irritation, and cosmetic concerns that can limit tendon gliding and hand function. Two incision techniques are commonly used: longitudinal (along the axis of the finger) and transverse/oblique (within the distal palmar crease). Proponents of the longitudinal incision emphasize improved visualization and extensibility, while proponents of the transverse incision highlight superior cosmesis and faster healing. Despite the frequency of this procedure, high-quality evidence comparing these approaches remains limited. This trial was designed to address this knowledge gap in a setting of clinical equipoise, where surgeons at the participating centers routinely use both techniques. The primary objective is to compare post-operative upper-extremity function, as measured by the PROMIS Upper Extremity (UE) score at approximately 6 weeks, between the longitudinal and transverse incision groups. Secondary objectives include comparing post-operative pain (Numeric Pain Scale), time to return to work, time to pain-free finger extension (tabletop test), additional PROMIS domains (Physical Function, Pain Interference, and Depression), scar outcomes using validated scales (POSAS, SCAR-Q, and 0-10 global satisfaction), and complication rates (wound dehiscence, infection, return to OR, and revision surgery). This investigator-initiated, multicenter, 1:1 randomized controlled trial will enroll approximately 200 participants across participating sites, with Washington University School of Medicine/Barnes-Jewish Hospital system serving as the lead site and the University of Chicago as a second site. Block randomization, stratified by site, will be performed immediately after consent using a secure web-based randomization system. Eligible participants are adults ≥18 years old with a diagnosis of trigger finger (fingers only) who provide written informed consent; exclusion criteria include revision surgery, prior surgery on the affected finger, or refusal of consent. The intervention consists of standard open A1 pulley release performed through either a longitudinal incision or a transverse incision placed in the distal palmar crease, with all other aspects of surgical technique and post-operative care standardized. Intra-operative data collected will include the need for FDS excision and any incision extension. The primary outcome is the PROMIS Upper Extremity score at ~6 weeks post-operatively. Secondary outcomes include Numeric Pain Scale scores (days 1-3, ~2 weeks, ~6 weeks, and ~12 weeks), days to return to work, days to pain-free finger extension (tabletop test), PROMIS Physical Function, Pain Interference, and Depression scores, scar metrics (POSAS, SCAR-Q, and 0-10 global satisfaction) at ~2, ~6, and ~12 weeks, and complication rates. Study procedures include pre-operative collection of demographics, medical history (including diabetes, depression/anxiety, and chronic opioid use), trigger finger details, and baseline PROMIS scores. Post-operatively, pain reports will be collected on days 1-3, with in-person or virtual assessments at ~2 weeks, ~6 weeks (primary endpoint), and ~12 weeks; scar photographs will be obtained during in-person visits. All data will be entered into a Washington University REDCap instance. Continuous outcomes will be compared using t-tests or Mann-Whitney U tests, while categorical outcomes will use chi-square or Fisher's exact tests; mixed-effects models will account for repeated measures and site effects. The sample size was calculated to detect a 4-point difference in PROMIS UE score (minimal clinically important difference) with 80% power and α=0.05, accounting for the reported standard deviation. The results of this trial will provide evidence-based guidance on optimal incision selection to improve functional recovery, reduce pain, optimize scar healing, and enhance patient satisfaction after A1 pulley release.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60537
        • Recruiting
        • The University of Chicago Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer Wolf, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University and Barnes-Jewish Orthopedic Center
        • Principal Investigator:
          • Jason Strelzow, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ryan Calfee, MD
        • Sub-Investigator:
          • Nisha N Kale, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (age ≥ 18 years)
  • Diagnosed with trigger finger (stenosing tenosynovitis) of a finger (excluding the thumb)
  • Written informed consent obtained

Exclusion Criteria:

  • Revision surgery
  • Previous surgery on the affected finger
  • Patients refusing consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Open A1 Pulley Release
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.
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.
Procedure: Open A1 Pulley Release
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Upper Extremity Score
Time Frame: Approximately 6 weeks post-operatively
Patient-reported upper extremity function measured by the PROMIS Upper Extremity (UE) scale (range: 0-100, where higher scores indicate better upper extremity function).
Approximately 6 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Scale (NPS)
Time Frame: Days 1-3, approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
Self-reported pain intensity measured by the Numeric Pain Scale (range: 0-10, where 0 = no pain and 10 = worst possible pain; higher scores indicate worse pain).
Days 1-3, approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
Days to Return to Work
Time Frame: Up to 12 weeks post-operatively
Number of days from surgery until the patient returns to work (or usual activities if retired/unemployed).
Up to 12 weeks post-operatively
Time to Pain-Free Finger Extension (Tabletop Test)
Time Frame: Up to 12 weeks post-operatively
Number of days from surgery until the patient achieves pain-free finger extension, assessed by the tabletop test. This is a binary test (yes/no) which assesses if the patient can lay their hand flat on a tabletop without any residual triggering.
Up to 12 weeks post-operatively
PROMIS Physical Function Score
Time Frame: Approximately 6 weeks and 12 weeks post-operatively
Patient-reported physical function measured by the PROMIS Physical Function scale (range: 0-100, where higher scores indicate better physical function).
Approximately 6 weeks and 12 weeks post-operatively
PROMIS Pain Interference Score
Time Frame: Approximately 6 weeks and 12 weeks post-operatively
Patient-reported pain interference measured by the PROMIS Pain Interference scale (range: 0-100, where higher scores indicate greater pain interference / worse outcome).
Approximately 6 weeks and 12 weeks post-operatively
PROMIS Depression Score
Time Frame: Approximately 6 weeks and 12 weeks post-operatively
Patient-reported depressive symptoms measured by the PROMIS Depression scale (range: 0-100, where higher scores indicate more depressive symptoms / worse outcome).
Approximately 6 weeks and 12 weeks post-operatively
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
Scar quality assessed by the Patient and Observer Scar Assessment Scale (POSAS; total score range 6-60 per scale, where higher scores indicate worse scar appearance and symptoms).
Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
SCAR-Q Score
Time Frame: Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
Patient-reported scar outcome measured by the SCAR-Q (higher scores indicate better scar outcome).
Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
Global Satisfaction with Scar
Time Frame: Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
Patient global satisfaction with scar appearance and symptoms measured on a numeric rating scale (range: 0-10, where 0 indicates completely dissatisfied and 10 indicates completely satisfied; higher scores indicate better outcome).
Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively
Complication Rate
Time Frame: Up to 12 weeks post-operatively
Rate of post-operative complications including wound dehiscence, infection, return to the operating room, and need for revision surgery (reported as the proportion of patients experiencing each event).
Up to 12 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

University of Chicago

Investigators

  • Principal Investigator: Jason Strelzow, MD, Associate Professor, Orthopaedic Surgery Division of Hand and Microsurgery, Washington University in St Louis
  • Study Chair: Ryan Calfee, MD, Professor, Orthopaedic Surgery Division of Hand and Microsurgery Chief, Hand and Microsurgery Service Medical Director, Washington University and Barnes-Jewish Orthopedic Center
  • Study Director: Nisha N Kale, MD, Washington University in St. Louis Department of Orthopaedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202506034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data (IPD) with other researchers. This is an investigator-initiated multicenter randomized trial; data will remain with the study team and will only be used for analysis and publication of aggregate study results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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