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Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique.

Authors :
Eberlin KR
Amis BP
Berkbigler TP
Dy CJ
Fischer MD
Gluck JL
Kaplan FTD
McDonald TJ
Miller LE
Palmer A
Perry PE
Walker ME
Watt JF
Source :
Expert review of medical devices [Expert Rev Med Devices] 2023 Jul; Vol. 20 (7), pp. 597-605. Date of Electronic Publication: 2023 May 30.
Publication Year :
2023

Abstract

Background: Comparative studies of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open CTR (mOCTR) are limited, prompting development of this randomized trial to compare efficacy and safety of these techniques.<br />Research Design and Methods: Patients were randomized (2:1) to CTR-US or mOCTR, treated by experienced hand surgeons (median previous cases: 12 CTR-US; 1000 mOCTR), and followed for 3 months.<br />Results: Among 149 randomized patients, 122 received CTR-US ( n  = 94) or mOCTR ( n  = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) ( p  < 0.001). Median time to return to daily activities (2 vs. 2 days; p  = 0.81) and work (3 vs. 4 days; p  = 0.61) were similar. Both groups reported statistically significant and clinically important improvements in Boston Carpal Tunnel Questionnaire Symptom Severity and Functional Status Scales, Numeric Pain Scale, and EuroQoL-5 Dimension 5-Level, with no statistical differences between groups. Freedom from wound sensitivity and pain favored CTR-US (61.1% vs. 17.9%; p  < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%; p  = 0.55).<br />Conclusions: The efficacy and safety of CTR-US were comparable to mOCTR despite less previous surgical experience with CTR-US. The choice of CTR technique should be determined by shared decision-making between patient and physician.<br />Clinical Trial Registration: www.clinicaltrials.gov identifier is NCT05405218.

Details

Language :
English
ISSN :
1745-2422
Volume :
20
Issue :
7
Database :
MEDLINE
Journal :
Expert review of medical devices
Publication Type :
Academic Journal
Accession number :
37254502
Full Text :
https://doi.org/10.1080/17434440.2023.2218548