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Trigger FingerNCT07516652

Prospective Randomized Trial Comparing Longitudinal vs. Transverse A1 Pulley Release

A study testing Open A1 Pulley Release in people with Trigger Finger and Stenosing Tenosynovitis, run by Washington University School of Medicine at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trigger Finger, Stenosing Tenosynovitis
What is being tested?
Open A1 Pulley Release
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesUnited States
Study dates
1 Apr 2026to 30 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nisha N Kale, MD contact

314-906-2072

kale.n@wustl.edu

Jason Strezlow, MD contact

(314) 514-3500

strelzow@wustl.edu

United States2 sites, 2 recruiting

  • The University of Chicago Medicine

    Chicago, Illinois, 60537

    Jennifer Wolf, MD, 773-834-3531, jwolf@bsd.uchicago.edu

    Oluwafemi Afolabi, Administrative Specialist, 773-702-6254, oluwafemi.afolabi@bsd.uchicago.edu

    Recruiting

  • Washington University and Barnes-Jewish Orthopedic Center

    St Louis, Missouri, 63110

    Alli Rittenhouse, (314) 747-2652, allir@wustl.edu

    Matthew Berning, (314) 514-3500, berning@wustl.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Open A1 Pulley Release
Keywords
trigger finger, stenosing tenosynovitis, A1 pulley release, longitudinal incision, hand surgery, randomized controlled trial, scar outcomes, PROMIS, patient-reported outcomes
Medical subject headings
Trigger Finger Disorder, Tendon Entrapment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open A1 Pulley ReleaseProcedure or surgery

    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 groups in NCT07516652
Study groupRoleWhat they receive
Longitudinal IncisionExperimentalParticipants randomized to this arm will undergo standard open A1 pulley release for trigger finger using a longitudinal incision along the axis of the finger.
Receives: Procedure: Open A1 Pulley Release
Transverse IncisionExperimentalParticipants randomized to this arm will undergo standard open A1 pulley release for trigger finger using a transverse incision placed in the distal palmar crease.
Receives: Procedure: Open A1 Pulley Release

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Approximately 6 weeks post-operatively

Secondary outcomes (10)

  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).

    Measured: Days 1-3, approximately 2 weeks, 6 weeks, and 12 weeks post-operatively

  2. Days to Return to Work

    Number of days from surgery until the patient returns to work (or usual activities if retired/unemployed).

    Measured: Up to 12 weeks post-operatively

  3. 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.

    Measured: Up to 12 weeks post-operatively

  4. 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).

    Measured: Approximately 6 weeks and 12 weeks post-operatively

  5. PROMIS Pain Interference Score

    Patient-reported pain interference measured by the PROMIS Pain Interference scale (range: 0-100, where higher scores indicate greater pain interference / worse outcome).

    Measured: Approximately 6 weeks and 12 weeks post-operatively

  6. PROMIS Depression Score

    Patient-reported depressive symptoms measured by the PROMIS Depression scale (range: 0-100, where higher scores indicate more depressive symptoms / worse outcome).

    Measured: Approximately 6 weeks and 12 weeks post-operatively

  7. Patient and Observer Scar Assessment Scale (POSAS)

    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).

    Measured: Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively

  8. SCAR-Q Score

    Patient-reported scar outcome measured by the SCAR-Q (higher scores indicate better scar outcome).

    Measured: Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively

  9. Global Satisfaction with Scar

    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).

    Measured: Approximately 2 weeks, 6 weeks, and 12 weeks post-operatively

  10. Complication Rate

    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).

    Measured: Up to 12 weeks post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel assignment randomized controlled trial with two arms. Eligible adults diagnosed with trigger finger are randomized 1:1 to receive open A1 pulley release using either a longitudinal incision or a transverse incision placed in the distal palmar crease. Each participant is assigned to only one incision type and remains in that arm for the full 12-week follow-up period. There is no crossover.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07516652
Sponsor's protocol ID
202506034
Status last verified
Mar 2026
First submitted
26 Mar 2026
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Ziolkowski NI, Pusic AL, Fish JS, Mundy LR, Wong She R, Forrest CR, Hollenbeck S, Arriagada C, Calcagno M, Greenhalgh D, Klassen AF. 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. Plast Reconstr Surg. 2020 Sep;146(3):331e-338e. doi: 10.1097/PRS.0000000000007078.

    PubMed 32842115

  • Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

    PubMed 15253184

  • Doring AC, Nota SP, Hageman MG, Ring DC. Measurement of upper extremity disability using the Patient-Reported Outcomes Measurement Information System. J Hand Surg Am. 2014 Jun;39(6):1160-5. doi: 10.1016/j.jhsa.2014.03.013. Epub 2014 May 3.

    PubMed 24799143

  • Fiorini HJ, Tamaoki MJ, Lenza M, Gomes Dos Santos JB, Faloppa F, Belloti JC. Surgery for trigger finger. Cochrane Database Syst Rev. 2018 Feb 20;2(2):CD009860. doi: 10.1002/14651858.CD009860.pub2.

    PubMed 29460276

  • Peters-Veluthamaningal C, van der Windt DA, Winters JC, Meyboom-de Jong B. Corticosteroid injection for trigger finger in adults. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD005617. doi: 10.1002/14651858.CD005617.pub2.

    PubMed 19160256

  • Kloeters O, Ulrich DJ, Bloemsma G, van Houdt CI. Comparison of three different incision techniques in A1 pulley release on scar tissue formation and postoperative rehabilitation. Arch Orthop Trauma Surg. 2016 May;136(5):731-7. doi: 10.1007/s00402-016-2430-z. Epub 2016 Feb 29.

    PubMed 26926477

  • Kato N, Yoshizawa T, Sakai H. Useful MRI assessment for bowstringing of the flexor tendon after trigger finger release. J Orthop Sci. 2014 Jan;19(1):186-9. doi: 10.1007/s00776-012-0264-2. Epub 2012 Jun 29. No abstract available.

    PubMed 22744012

  • Ricci JA, Parekh NN, Desai NS. Release of the A1 Pulley for Trigger Finger Complicated by Flexor Tenosynovitis. J Hand Microsurg. 2015 Jun;7(1):220-3. doi: 10.1007/s12593-015-0171-9. Epub 2015 Jan 13. No abstract available.

    PubMed 26078548

  • Unglaub F, Cakmak F, Wolf MB, Hahn P. Letter regarding "Adverse events of open A1 pulley release for idiopathic trigger finger". J Hand Surg Am. 2012 Nov;37(11):2428-9; author reply 2429. doi: 10.1016/j.jhsa.2012.08.038. No abstract available.

    PubMed 23101540

  • Bruijnzeel H, Neuhaus V, Fostvedt S, Jupiter JB, Mudgal CS, Ring DC. Adverse events of open A1 pulley release for idiopathic trigger finger. J Hand Surg Am. 2012 Aug;37(8):1650-6. doi: 10.1016/j.jhsa.2012.05.014. Epub 2012 Jul 3.

    PubMed 22763058

  • Will R, Lubahn J. Complications of open trigger finger release. J Hand Surg Am. 2010 Apr;35(4):594-6. doi: 10.1016/j.jhsa.2009.12.040. Epub 2010 Feb 26.

    PubMed 20189319

  • Nimigan AS, Ross DC, Gan BS. Steroid injections in the management of trigger fingers. Am J Phys Med Rehabil. 2006 Jan;85(1):36-43. doi: 10.1097/01.phm.0000184236.81774.b5.

    PubMed 16357547

  • Hansen RL, Sondergaard M, Lange J. Open Surgery Versus Ultrasound-Guided Corticosteroid Injection for Trigger Finger: A Randomized Controlled Trial With 1-Year Follow-up. J Hand Surg Am. 2017 May;42(5):359-366. doi: 10.1016/j.jhsa.2017.02.011. Epub 2017 Mar 22.

    PubMed 28341069

  • Gil JA, Hresko AM, Weiss AC. Current Concepts in the Management of Trigger Finger in Adults. J Am Acad Orthop Surg. 2020 Aug 1;28(15):e642-e650. doi: 10.5435/JAAOS-D-19-00614.

    PubMed 32732655

  • Gorsche R, Wiley JP, Renger R, Brant R, Gemer TY, Sasyniuk TM. Prevalence and incidence of stenosing flexor tenosynovitis (trigger finger) in a meat-packing plant. J Occup Environ Med. 1998 Jun;40(6):556-60. doi: 10.1097/00043764-199806000-00008.

    PubMed 9636936

Questions about this trial

What is this clinical trial studying?

A study testing Open A1 Pulley Release in people with Trigger Finger and Stenosing Tenosynovitis, run by Washington University School of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nisha N Kale, MD (314-906-2072, kale.n@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS Upper Extremity Score (time frame: Approximately 6 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07516652, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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