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OpenTrials
Completed

NCT Number: NCT07364695

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

Trigger finger is initially treated conservatively. Conservative treatment options include modification of activities, painkiller administration, splinting, and corticosteroid injections (1). Open or minimally invasive surgical treatment can be considered if conservative treatment fails. Minimally invasive surgery options consist of ultrasound-guided or blind percutaneous trigger finger release.

Many studies have reported good clinical outcomes after ultrasound-guided trigger finger release, including low rates of catching or locking recurrence rates, high QuickDASH scores and high patient satisfaction (2-4).

Postoperative clinical outcomes of open surgery have been widely compared to percutaneous surgery (5-8). However, the comparison of postoperative results between ultrasound-guided and open trigger finger release has been scarcely reported. Nikolaou et al. reported that ultrasound-guided trigger finger release resulted in a significantly sooner return to normal activities and better patient-reported cosmetic outcomes than open trigger finger release (9). Success rates and mean QuickDASH scores did not differ significantly between these groups in this cohort.

The potential benefits of ultrasound-guided trigger finger release compared to open trigger finger release have yet to be investigated. This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

UltraGuideTFR (Sonex Health, MN, USA)

Device

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

Primary outcomes

  1. Activities of Daily Living (Study-specific questionnaire)

    Time frame: From enrollment to final follow-up at 6 months

    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.

  2. Pain on the Visual Analogue Scale

    Time frame: From enrollment to final follow-up at 6 months

    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.

Secondary outcomes

  1. Timing of Return to work

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

    Timing of return to work in days as reported by patient. Minimum value is 0 days, meaning patient reported returning to work on the day of the procedure. No maximum value applicable.

  2. Patient satisfaction with procedure

    Time frame: Single evaluation at final follow-up 6 months post-procedure

    Patient reported satisfaction with procedure. Response of either yes or no to the following question: Are you satisfied with the procedure, and would you choose to have it again for a similar problem?

Other outcomes

  1. Proximal interphalangeal joint (PIPJ) flexion

    Time frame: Assessments at the preoperative and two-week follow-up visits

    Proximal interphalangeal (PIP) flexion measured with a goniometer and recorded in degrees. Minimum and maximum values within physiologic range of motion for the PIPJ.

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

    Time frame: Assessments at the preoperative and two-week follow-up visits

    Distance in millimeters from fingertip to the distal palmar crease (DPC) in composite flexion. Minimum of 0 cm, maximum value of >5 cm which represents absence of functionally meaningful finger flexion.

  3. PIPJ flexion contracture (if present)

    Time frame: Assessments at the preoperative and two-week follow-up visits

    If present, PIPJ flexion contracture measured using a goniometer and recorded in degrees. Minimum value of 0 degrees representing absence of flexion contracture, maximum value within physiologic range of motion for the PIPJ.

  4. Analegesia requirement

    Time frame: From enrollment to final follow-up at 6 months

    Pain medication requirement including acetaminophen, anti-inflammatories, and/or narcotics. Open response from patients for the following question: How many oxycodone or other narcotic medications are you taking post-op?

  5. Grip Strength

    Time frame: Assessments at the preoperative and two week follow-up visits

    Grip strength was evaluated using a Jamar dynamometer setting #2.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release: A Prospective Comparative Cohort Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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