- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364695
Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release
Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release: A Prospective Comparative Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02114
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Open Release
Patients who underwent open trigger finger release
|
|
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Ultrasound-Guided Release
Patients who underwent ultrasound-guided trigger finger release
|
SonexHealth percutaneous trigger finger release device used in ultrasound-guided release cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to final follow-up at 6 months
|
|
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.
|
From enrollment to final follow-up at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From 2 days post-procedure to final follow-up at 6 months
|
|
Patient satisfaction with procedure
Time Frame: Single evaluation at final follow-up 6 months post-procedure
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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?
|
Single evaluation at final follow-up 6 months post-procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
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Assessments at the preoperative and two-week follow-up visits
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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.
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Assessments at the preoperative and two-week follow-up visits
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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?
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From enrollment to final follow-up at 6 months
|
|
Grip Strength
Time Frame: Assessments at the preoperative and two week follow-up visits
|
Grip strength was evaluated using a Jamar dynamometer setting #2.
|
Assessments at the preoperative and two week follow-up visits
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rohit Garg, MBBS, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P003220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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