ClinicalTrials.gg
CompletedNCT07364695Updated Mar 25, 2026

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

An observational study in Trigger Finger, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Trigger Finger

Keywords

  • trigger finger release
  • ultrasound
  • open
  • clinical outcomes
  • return to work
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

This study's enrollment of 60 is below the median of 68 across 14 observational studies indexed under Trigger Finger Disorder.

Browse Trigger Finger Disorder studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • undergoing trigger finger release for the index through small fingers due to symptoms 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

Exclusion Criteria:

  • prior surgery on the affected finger
  • 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceUltraGuideTFR (Sonex Health, MN, USA)

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Timing of Return to work

    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.

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

  2. Patient satisfaction with 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?

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

Other outcomes

  1. Proximal interphalangeal joint (PIPJ) flexion

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

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

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

    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.

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

  3. PIPJ flexion contracture (if present)

    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.

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

  4. Analegesia requirement

    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?

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

  5. Grip Strength

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

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

07

Study locations

2 sites
  • Brigham and Women's Hospital
    Boston, Massachusetts 02114, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Anonymized patient data can be shared upon reasonable request for transparency

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Jun 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2025
First posted
Jan 23, 2026
StartActual
Jun 20, 2023
Primary completionActual
Jun 26, 2024
CompletionActual
Dec 31, 2024
Last update
Mar 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07364695
Responsible party
Rohit Garg (Director, Hand Surgery Fellowship Program, Assistant Professor of Orthopedic Surgery, Massachusetts General Hospital) — Principal investigator
First posted
Jan 23, 2026
Start date
Jun 20, 2023
Primary completion
Jun 26, 2024
Completion
Dec 31, 2024
Last update
Mar 25, 2026

Study contacts

Rohit Garg, MBBS
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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