Clinical Research

Carpal tunnel release using ultrasound (US) guidance was initially described by Nakamichi in 1997.12,13

Since then over 1200 cases have been reported in the peer-reviewed literature using a variety of cutting knives or instruments not specifically designed for CTR using US Guidance.14,15

Despite these limitations, there have been no reported neurovascular complications and the collective clinical success rate has been over 95%.14,15

Clinical Experience

The first CTR using the SX-One MicroKnife® with US guidance was performed on February 17, 2017.
  • Over 7700 procedures completed, including many simultaneous bilateralreleases.15-17 
  • Over 60 physician users in 23 different states. 
  • Procedures performed in the ASC, OR and clinic office setting – most procedures  performed using only local anesthesia/WALANT technique.15-18 
  • Post-operative discomfort typically managed with acetaminophen or NSAIDs as necessary: no opioids required.15-18 
  • Patients are generally allowed to resume activities as tolerated (at physician’s discretion). 

CTR using ultrasound guidance V.S. mini-Open CTR (Randomized Clinical Trial)

Data reproduced from a prospective, randomized trial comparing the two techniques (mini-open CTR without US guidance (red line) and CTR with US guidance (blue line) showed that patients treated with CTR using US guidance recovered significantly faster during the first 3-6 weeks compared to traditional mOCTR.9

Long-Term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance: A Multicenter Pragmatic Study

“Purpose: The purpose of this study was to report the 1-year clinical outcomes of carpal tunnel release using ultrasound guidance (CTR-US)performed in a large, real-world population of patients enrolled in a multicenter registry.”

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Citations

  1. Papanicolaou GD, et al. The prevalence and characteristics of nerve compression symptoms in the general  population. J Hand Surg Am 2001;26:460-6. 
  2. Dale AM, et al. Prevalence and incidence of carpal tunnel syndrome in the US working population: pooled  analysis of six prospective studies. Scand J Work Environ Health 2013;39:495-505. 
  3. Fajardo M, et al. Incidence of carpal tunnel release: trends and implications within the United States  ambulatory care setting. J Hand Surg Am 2012;37:1599-1605. 
  4. Padua L, et al. Carpal tunnel syndrome: clinical features, diagnosis and management. Lancet Neurol  2016;15:1273-84. 
  5. Graham B, et al. The American Academy of Orthopaedic Surgeons evidence-based clinical practice  guidelines on management of carpal tunnel syndrome. J Bone Joint Surg 2016;98A:1750-4. 
  6. Kim PT, et al. Current approaches for carpal tunnel syndrome. Clin Orthop Surg 2014;6:253-7. 
  7. Vasiliadis HS, et al. Endoscopic and open release are similarly safe for the treatment of carpal tunnel  syndrome: a systematic review and meta-analysis. PLoS One 2015;10:e0143683. 
  8. Murthy PG, et al. Mini-open versus extended open release for severe carpal tunnel syndrome. HAND  2015;10:34-9. 
  9. Rojo-Manaute JM, et al. Ultra-minimally invasive ultrasound-guided carpal tunnel release: a randomized  clinical trial. J Ultrasound Med 2016;35:1149-57. 
  10. Sayegh ET, et al. Open versus endoscopic carpal tunnel release: a meta-analysis of randomized controlled  trials. Clin Orthop Rel Res 2015;473:1120-1132. 
  11. Zhang S, et al. Cost-minimization analysis of open and endoscopic carpal tunnel release. J Bone JointSurg  Am 2016;98:1970-7. 
  12. Nakamichi K, Tachibana S. Ultrasonographically assisted carpal tunnel release. J Hand SurgAm  1997;22:853-62. 
  13. Nakamichi KS, et al. Percutaneous carpal tunnel release compared with mini-open release using ultrasound  guidance for both techniques. J Hand Surg Am 2010;35:437-45. 
  14. Henning PT, et al. Minimally invasive ultrasound guided carpal tunnel release: preliminary clinicalresults.  J Ultrasound Med 2018;37:2699-706.
  15. Leiby BM, et al. Long-term clinical results of carpal tunnel release using ultrasound guidance. HAND  2021;108 DOI: 10.1177/1558944720988080. 
  16. Chappell CD, et al. Sonographic changes in median nerve cross sectional area following microinvasive  ultrasound guided carpal tunnel release. J Ultrasound Med 2020;39:693-702. 
  17. Joseph AE, et al. Clinical results of ultrasound guided carpal tunnel release performed by a primary  care sports medicine physician. J Ultrasound Med 2020;39:441-52. 
  18. Kamel SI, et al. Minimally invasive ultrasound-guided carpal tunnel release improves long-term  clinical outcomes in carpal tunnel syndrome. Am J Roentgenology. DOI:10.22114/AJR.20.24383.