Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07516652

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

Led by Washington University School of Medicine · Updated on 2026-04-08

200

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

U

University of Chicago

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial investigates adults with trigger finger, a condition where a finger locks due to swelling around the tendons. It compares two types of skin cuts used in surgery to release the finger pulley: a longitudinal incision along the finger and a transverse incision across the palm crease. The study aims to find which incision leads to better hand function, less pain, improved scar healing, and quicker return to normal activities. Participants will undergo surgery to release the pulley using one of the two incision types assigned randomly. Both surgeries follow the same techniques for the release and post-operative care. The trial will compare hand function about 6 weeks after surgery using the PROMIS Upper Extremity score. Secondary measures include pain levels, scar appearance, time to return to work, finger movement without pain, and complication rates. During the study, participants complete questionnaires about hand function and pain before and after surgery. Pain is recorded daily for the first three days and at follow-ups around 2, 6, and 12 weeks. Scars are assessed and photographed at these visits. Researchers will monitor complications and collect detailed data on recovery. The total follow-up lasts about 12 weeks after surgery to evaluate healing and satisfaction.

CONDITIONS

Brief Title

Prospective Randomized Trial Comparing Longitudinal vs. Transverse A1 Pulley Release

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (age 65 18 years)
  • Diagnosed with trigger finger (stenosing tenosynovitis) of a finger (excluding the thumb)
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo standard open A1 pulley release surgery using either a longitudinal or transverse incision based on randomization, followed by standardized post-operative care.

Surgery visit plus daily pain assessments on days 1 to 3

Post-operative Follow-up

Duration - Approximately 12 weeks

Participants are monitored for recovery including function, pain, scar healing, and complications through scheduled assessments.

In-person or virtual visits at approximately 2 weeks, 6 weeks, and 12 weeks

Trial Site Locations

Total: 2 locations

1

The University of Chicago Medicine

Chicago, Illinois, United States, 60537

Actively Recruiting

2

Washington University and Barnes-Jewish Orthopedic Center

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

N

Nisha N Kale, MD

J

Jason Strezlow, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Psychometric Findings for the SCAR-Q Patient-Reported Outcome Measure Based on 731 Children and Adults with Surgical, Traumatic, and Burn Scars from Four Countries.

Natalia I Ziolkowski, Andrea L Pusic, Joel S Fish...

https://pubmed.ncbi.nlm.nih.gov/32842115

The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation.

Lieneke J Draaijers, Fenike R H Tempelman, Yvonne A M Botman...

https://pubmed.ncbi.nlm.nih.gov/15253184

Measurement of upper extremity disability using the Patient-Reported Outcomes Measurement Information System.

Anne-Carolin Döring, Sjoerd P F T Nota, Michiel G J S Hageman...

https://pubmed.ncbi.nlm.nih.gov/24799143

Comparison of three different incision techniques in A1 pulley release on scar tissue formation and postoperative rehabilitation.

Oliver Kloeters, Dietmar J O Ulrich, Gijs Bloemsma...

https://pubmed.ncbi.nlm.nih.gov/26926477