Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release

NCT07364695 | Completed FDA Device

• 1 other identifier: 2023P003220
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Clinical outcomes after open trigger finger release are excellent. Minimally invasive techiques with ultrasound guidance theoretically offer advantages for faster recovery but this technique has not been compared prospectively with the standard of care (open trigger release). This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.

Conditions

Trigger Finger

Keywords

trigger finger release; ultrasound; open; clinical outcomes; return to work

Outcome Measures

Primary Outcomes (2)

• Activities of Daily Living (Study-specific questionnaire)

  Study-specific survey of limitations with Activities of Daily Living. Responses for questions on the study-specific survey for limitations with ADLS utilized a Likert scale with 1 representing no difficulty with the task and 5 being unable to perform the task due to limitations from trigger finger symptoms. Likert scale responses for the 12 ADLs on the survey were summated for final scores ranging from 14 (no difficulty with any ADLs) to 70 (unable to perform any ADLs). These were standardized to a 100-point scale to facilitate clinical interpretation of outcomes. A score of 0 represented no functional limitations with ADLs and a score of 100 represented inability to perform any ADL on the survey.

  From enrollment to final follow-up at 6 months

• Pain on the Visual Analogue Scale

  VAS pain score on a scale from 1 to 10 with a score of 1 representating no pain and score or 10 representing maximal pain.

  From enrollment to final follow-up at 6 months

Secondary Outcomes (2)

• Timing of Return to work

  From 2 days post-procedure to final follow-up at 6 months

• Patient satisfaction with procedure

  Single evaluation at final follow-up 6 months post-procedure

Other Outcomes (5)

• Proximal interphalangeal joint (PIPJ) flexion

  Assessments at the preoperative and two-week follow-up visits

• PIPJ motion as evaluated by distance from fingertip to distal palmar crease in composite flexion

  Assessments at the preoperative and two-week follow-up visits

• PIPJ flexion contracture (if present)

  Assessments at the preoperative and two-week follow-up visits

Study Arms (2)

Open Release

Patients who underwent open trigger finger release

Ultrasound-Guided Release

Patients who underwent ultrasound-guided trigger finger release

Device: UltraGuideTFR (Sonex Health, MN, USA)

Interventions

UltraGuideTFR (Sonex Health, MN, USA) DEVICE

SonexHealth percutaneous trigger finger release device used in ultrasound-guided release cohort

Ultrasound-Guided Release

Eligibility Criteria

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

Study Population

patients undergoing trigger finger release for the index through small fingers was conducted from June 2023 through June 2024 at two tertiary care academic medical centers in an integrated health network

You may qualify if:

• undergoing trigger finger release for the index through small fingers due to symptoms refractory to conservative treatment and elected for surgical intervention through shared decision-making
• English-speaking adults (≥18 years of age)
• Patients with inflammatory arthritis were included if their diagnosis had been established ≥5 years prior without exacerbations in the past 5 years. Those on immunomodulatory therapy were required to have been on a stable regimen for ≥5 years without flare-ups.

You may not qualify if:

• prior surgery on the affected finger
• corticosteroid injection in the affected hand within 6 weeks
• additional hand or wrist pathology requiring concurrent surgery
• symptomatic trigger finger in the contralateral extremity
• prior surgical pulley release in either hand within 6 months of enrollment
• Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus) not controlled
• inflammatory arthritis if diagnosis established \<5 years, exacerbation within the past 5 years, or modifications to immunomodulatory therapy within 5 years of enrollment
• Amyloidosis
• Diabetes not controlled by a stable dose of medication over the past three months
• Pregnant or planning pregnancy in the next 6 months
• Workers' compensation subjects
• Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements, including patients who do not speak English
• other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
• Trigger Thumb

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Rohit Garg, MBBS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hand Surgery Fellowship Program, Assistant Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 23, 2026
• Study Start: June 20, 2023
• Primary Completion: June 26, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2023 through January 2027
• Access Criteria: De-identified IPD will be available to qualified researchers who submit a methodologically sound proposal. Requests may be made to the principal investigator. Access will be provided through a secure data-sharing platform following execution of a data use agreement

Locations

US (2)