Publications Reporting Clinical Results with UltraGuideCTR™
Publications Reporting Clinical Results with UltraGuideCTR™
Note: SX-One MicroKnife has been renamed UltraGuideCTR. The device, intended use, indications for use, and clinical data regarding safety and effectiveness are the same.
Office-Based Carpal Tunnel Release Using Ultrasound Guidance in a Community Setting: Long-Term Results
Russell A Bergum, Mark R Ciota
Cureus. 2022 Jul 23;14(7):e27169. doi: 10.7759/cureus.27169. PMID: 35898805; PMCID: PMC9308387.
Prospective case series of 88 patients (123 hands) with minimum 1-year follow-up. All cases were confirmed by electrodiagnostic studies, and 2/3 of hands were moderately-severe or severe. All procedures were performed in an office-based procedure room using only local anesthesia and 46% of hands were treated as simultaneous bilateral procedures. Patients experienced statistically and clinically significant improvements in BCTQ-SSS, BCTQ-FSS and QDASH scores by 1-2 weeks post-procedure that persisted at 1 year. No intra-operative complications occurred; no conversions or supplementary analgesic medications were required. There were no neurovascular injuries, infections, or recurrences. One patient developed complex regional pain syndrome in the early post-operative period which was successfully treated; the patient subsequently had the contralateral hand treated with CTR using ultrasound guidance without complication.
Multicenter Pragmatic Study of Carpal Tunnel Release with Ultrasound Guidance
John R Fowler, Kevin C Chung, Larry E Miller
Expert Rev Med Devices. 2022 Mar;19(3):273-280. doi: 10.1080/17434440.2022.2048816. Epub 2022 Mar 10. PMID: 35236202.
Multicenter pragmatic study of 373 patients/427 hands with 6-month follow-up. Procedures were performed at 24 different sites, 88% were performed using only local anesthesia and 25% of hands were performed as simultaneous bilateral procedures. Nearly 2/3 of physicians has performed <20 procedures prior to first patients enrolling in the database. QDASH, BCTQ-SSS and BCTQ-FSS scores were significantly improved by 2 weeks, continued to improve throughout the 6-month follow-up, and exceeded minimal clinically important differences. Median return to normal activities was 3 days, and median return to work was 5 days (48% of working patients were manual laborers), both of which compared favorably to historical controls for OCTR/mOCTR. No neurovascular complications occurred. One patient had revision surgery due to persistent symptoms attributed to an incomplete release.
Long-term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance
Braeden M Leiby, John P Beckman, Anthony E Joseph
Hand (N Y). 2022 Nov;17(6):1074-1081. doi: 10.1177/1558944720988080. Epub 2021 Jan 21. PMID: 33511873.
Prospective case series of 47 patients (76 hands) with minimum 1-year follow-up. Nearly 1/3 of all hands with preoperative electrodiagnostic testing were graded as severe and over 70% of patients had one or more co-morbidities. 25 patients (50 hands) had bilateral simultaneous releases. Patients experienced statistically and clinically significant improvements in BCTQ-SSS, BCTQ-FSS and QDASH scores by 1-2 weeks post-procedure that persisted at 1 year. No complications occurred and there were no recurrences.
Minimally Invasive Ultrasound-Guided Carpal Tunnel Release Improves Long-Term Clinical Outcomes in Carpal Tunnel Syndrome
Sarah I Kamel, Bradley Freid, Corbin Pomeranz, Ethan J Halpern, Levon N Nazarian
AJR Am J Roentgenol. 2021 Aug;217(2):460-468. doi: 10.2214/AJR.20.24383. Epub 2020 Sep 2. PMID: 32876476.
Case series of 61 wrists in 46 patients for which > 1-year follow-up was available on 55 wrists/40 patients. All cases were performed using local anesthesia in a clinic procedure room. Patients experienced statistically and clinically significant improvements in QDASH and BCTQ scores by 2- weeks post-procedure, which persisted at a median follow-up of 1.7 years (1.0-2.8 years). Two patients lost to follow up at 1 year had re-operations, one for post-traumatic wound dehiscence with subsequent infection and one for possible compartment syndrome following racquet sport participation. In the latter case, surgical exploration revealed compression of the median nerve by the distal forearm fascia.
Ultrasound (US) Changes in the Median Nerve Cross-Sectional Area After Microinvasive US-Guided Carpal Tunnel Release
Craig D Chappell, John P Beckman, Brian C Baird, Amanda V Takke
J Ultrasound Med 2020;39: 693-702. PMID: 31659789 DOI: 10.1002/jum.15146
Report of 37 wrists in 23 consecutive patients treated with CTR using the SX-One MicroKnife® and ultrasound guidance. All procedures were performed in an office procedure room using only local anesthesia (WALANT). No complications occurred. The authors reported statistically significant reductions in median nerve cross-sectional area, as well as statistically and clinically significant improvements in BCTQ scores at 6-10 weeks post-release. Although the primary endpoint of the study was the change in median nerve cross sectional area at 6-10 weeks, statistically significant reductions in nerve CSA and BCTQ scores were also observed as early as 2-4 weeks post-release.
Clinical Results of Ultrasound-Guided Carpal Tunnel Release Performed by a Primary Care Sports Medicine Physician
Anthony E Joseph, Braeden M Leiby, John P Beckman
J Ultrasound Med 2020;39: 441-52. PMID: 31449326 DOI: 10.1002/jum.15120
Three-month follow-up on 35 wrists in 22 consecutive patients treated with CTR using the SX-One MicroKnife® and ultrasound guidance, including 11 patients treated with bilateral simultaneous releases. The authors reported no complications and there were statistically and clinically significant improvements in QDASH and BCTQ scores within 1-2 weeks post-release.
Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: Preliminary Clinical Results
P Troy Henning , Lynda Yang , Tariq Awan, Daniel Lueders, Adam M Pourcho
J Ultrasound Med. 2018 Nov;37(11):2699-2706. doi: 10.1002/jum.14618. Epub 2018 Apr 2.
Clinical experience at the University of Michigan reporting on 18 wrists in 14 patients, including several patients with disabilities who were able to immediately use their crutches and wheelchairs. Multiple cases were performed in the office setting using only local anesthesia. The authors reported no neurovascular complications and excellent clinical outcomes.
Sonographic Changes After Ultrasound-Guided Release of the Transverse Carpal Ligament: A Case Report
Erek W Latzka, P Troy Henning, Adam M Pourcho
PM&R 2018; 10: 1125-1129. doi: 10.1016/j.pmrj.2018.02.018. Epub 2018 Mar 6.
Case report documenting clinical improvement and reduction in median nerve cross- sectional area following CTR using the SX-One MicroKnife® with ultrasound guidance.
Ultrasound-Guided Carpal Tunnel Release Using Dynamic Expansion of the Transverse Safe Zone in a Patient With Postpolio Syndrome: A Case Report
Troy Henning, Daniel Lueders, Kate Chang, Lynda Yang
PM&R 2018; 10(10):1115-1118. doi: 10.1016/j.pmrj.2018.02.016.
Case report documenting the clinical outcome of a patient with post-polio syndrome who could immediately resume crutch weightbearing following CTR using the SX- One MicroKnife® and ultrasound guidance.