UltraGuideTFR (Sonex Health, MN, USA)
DeviceSonexHealth percutaneous trigger finger release device used in ultrasound-guided release cohort
NCT Number: NCT07364695
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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Notify Me18 year and older
All sexes
Observational
Brigham and Women's Hospital, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SonexHealth percutaneous trigger finger release device used in ultrasound-guided release cohort
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.
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.
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.
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?
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.
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.
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.
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?
Time frame: Assessments at the preoperative and two week follow-up visits
Grip strength was evaluated using a Jamar dynamometer setting #2.
Massachusetts General Hospital
Other
Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release: A Prospective Comparative Cohort Study
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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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