Prospective Randomized Trial Comparing Longitudinal vs. Transverse A1 Pulley Release

NCT07516652 | Recruiting DMC

• 1 other identifier: 202506034
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Trigger Finger; Stenosing Tenosynovitis

Keywords

trigger finger; stenosing tenosynovitis; A1 pulley release; longitudinal incision; hand surgery; randomized controlled trial; scar outcomes; PROMIS; patient-reported outcomes

Outcome Measures

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).

  Approximately 6 weeks post-operatively

Secondary Outcomes (10)

• Numeric Pain Scale (NPS)

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

• Days to Return to Work

  Up to 12 weeks post-operatively

• Time to Pain-Free Finger Extension (Tabletop Test)

  Up to 12 weeks post-operatively

• PROMIS Physical Function Score

  Approximately 6 weeks and 12 weeks post-operatively

• PROMIS Pain Interference Score

  Approximately 6 weeks and 12 weeks post-operatively

Study Arms (2)

Longitudinal Incision

EXPERIMENTAL

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

Transverse Incision

EXPERIMENTAL

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

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.

Longitudinal Incision; Transverse Incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: collaborator
• Washington University School of Medicine: lead

Study Sites (2)

The University of Chicago Medicine

Chicago, Illinois, 60537, United States

RECRUITING

Washington University and Barnes-Jewish Orthopedic Center

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 32842115 BACKGROUND

• 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.

  PMID: 15253184 BACKGROUND

• 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.

  PMID: 24799143 BACKGROUND

• 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.

  PMID: 29460276 BACKGROUND

• 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.

  PMID: 19160256 BACKGROUND

• 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.

  PMID: 26926477 BACKGROUND

• 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.

  PMID: 22744012 BACKGROUND

• 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.

  PMID: 26078548 BACKGROUND

• 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.

  PMID: 23101540 BACKGROUND

• 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.

  PMID: 22763058 BACKGROUND

• 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.

  PMID: 20189319 BACKGROUND

• 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.

  PMID: 16357547 BACKGROUND

• 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.

  PMID: 28341069 BACKGROUND

• 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.

  PMID: 32732655 BACKGROUND

• 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.

  PMID: 9636936 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder; Tendon Entrapment

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Jason Strelzow, MD

  Associate Professor, Orthopaedic Surgery Division of Hand and Microsurgery, Washington University in St Louis

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Nisha N Kale, MD

  Washington University in St. Louis Department of Orthopaedic Surgery

  STUDY DIRECTOR

Central Study Contacts

Nisha N Kale, MD

CONTACT

314-906-2072; kale.n@wustl.edu

Jason Strezlow, MD

CONTACT

(314) 514-3500; strelzow@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jason Strelzow, MD Associate Professor, Orthopaedic Surgery Division of Hand and Microsurgery Vice Chair of Faculty Affairs

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)