Prospective Randomized Trial Comparing Longitudinal vs. Transverse A1 Pulley Release
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (age ≥ 18 years)
Diagnosed with trigger finger (stenosing tenosynovitis) of a finger (excluding the thumb)
Written informed consent obtained
Disqualifiers
Revision surgery
Previous surgery on the affected finger
Patients refusing consent
Trial design
Design model
Parallel
Treatments tested in this trial
Open A1 Pulley Release
Procedure/SurgerySurgical 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Longitudinal IncisionExperimental treatment 1 intervention
Group B: Transverse IncisionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PROMIS Upper Extremity Score
Patient-reported upper extremity function measured by the PROMIS Upper Extremity (UE) scale (range: 0-100, where higher scores indicate better upper extremity function).
Time frame
Approximately 6 weeks post-operativelySecondary outcomes
1
Numeric Pain Scale (NPS)
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).
Time frame
Days 1-3, approximately 2 weeks, 6 weeks, and 12 weeks post-operatively2
Days to Return to Work
Number of days from surgery until the patient returns to work (or usual activities if retired/unemployed).
Time frame
Up to 12 weeks post-operatively3
Time to Pain-Free Finger Extension (Tabletop Test)
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.
Time frame
Up to 12 weeks post-operatively4
PROMIS Physical Function Score
Patient-reported physical function measured by the PROMIS Physical Function scale (range: 0-100, where higher scores indicate better physical function).
Time frame
Approximately 6 weeks and 12 weeks post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
University of Chicago
Collaborator
Source ClinicalTrials.gov