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

Kyle R. Eberlin, Benjamin P. Amis, Thomas P. Berkbigler, Christopher J. Dy, Mark D. Fischer, James L. Gluck, F. Thomas D. Kaplan, Thomas J. McDonald, Larry E. Miller, Alexander Palmer, Paul E. Perry, Marc E. Walker, James F. Watt

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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. 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. 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). 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. Clinical trial registration: www.clinicaltrials.gov identifier is NCT05405218.

Original languageEnglish
Pages (from-to)597-605
Number of pages9
JournalExpert Review of Medical Devices
Volume20
Issue number7
DOIs
StatePublished - 2023

Keywords

  • Carpal tunnel release
  • TUTOR
  • UltraGuideCTR
  • carpal tunnel syndrome
  • randomized controlled trial
  • ultrasound

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