UltraGuideCTR™, formerly known as the SX-One MicroKnife, is the same device with the same intended use, indications for use and clinical data regarding the safety and effectiveness of the device.
Clinical research is fundamental to Sonex Health’s mission to deliver physicians innovative therapies that reduce invasiveness, improve safety, and reduce the cost of care.
Carpal Tunnel Release with Ultrasound Guidance
CTR with real-time ultrasound guidance was initially described by Nakamichi in 1997.11,15 Since then, 1,300 clinical cases have been reported in peer reviewed literature.10 There have been no reported neurovascular complications and the collective clinical success rate is over 95%.10
Randomized Clinical Trial
CTR with ultrasound guidance compared to mini-open CTR
Prospective randomized trial comparing CTR with real-time ultrasound guidance to traditional mini-OCTR without ultrasound guidance demonstrated that patients treated with CTR using real-time ultrasound guidance recovered faster.4
The first CTR using UltraGuideCTR™ with real-time ultrasound guidance was performed February 17, 2017.
- Over 15,000 procedures completed including many bilateral simultaneous releases9,13,14
- Procedures performed in the ASC, OR and clinic office setting – most procedures performed using only local anesthesia/WALANT technique9
- Post-operative discomfort typically managed with acetaminophen or NSAIDs as necessary9
- Most patients can return to work in 3-6 days4,9
Carpal Tunnel Release with UltraGuideCTR and Real-Time Ultrasound Guidance Manuscripts
UltraGuideCTR, formerly known as the SX-One MicroKnife. UltraGuideCTR is the same device with the same intended use, indications for use and clinical data regarding the safety and effectiveness of the device.
UltraGuideCTR™ with Ultrasound Guidance Performed in an Office-Based Setting Provides Safe, Effective, and Sustained Clinical Improvements at One Year in a Community Population
One-year follow up was available for 123 hands (69 right, 54 left) in 88 patients (57% female). All procedures were performed in an office-based procedure room using only local anesthesia. 46% (57/123) of hands were treated as simultaneous bilateral procedures. BCTQ-SSS, BCTQ-FSS, and QDASH scores demonstrated statistically significant improvements at 2 weeks, with mean reductions of 1.19, 0.64, and 14.06, respectively. Long-term outcomes were sustained at 1 year, with mean reductions of 1.73, 1.24, and 32.10, respectively. No statistically significant differences in improvement were observed between hands treated as part of unilateral, simultaneous bilateral, or staged bilateral procedures. No reports of neurovascular or tendon injuries, infections or significant post-surgical wound complications; no recurrences or reoperations.
Clinically Meaningful Improvements in Symptoms and Function, Rapid Return to Normal Activities, and Minimal Work Absenteeism in Real-World Clinical Practice
Six month follow up on 535 patients treated with UltraGuideCTR using ultrasound guidance, including 54 bilateral releases. 88% of procedures were performed using only local anesthesia. No major neurovascular complications were reported. The authors reported statistically and clinically significant improvements in QDASH, BCTQ-FSS and BCTQ-SSS at 2 weeks through 6 months. The median time to return to activities and return to work were 3 days and 5 days, respectively. Approximately 90% of patients were satisfied or very satisfied with the procedure at 2 weeks through 6 months.
Statistically significant reductions in median nerve cross-sectional area following CTR using the SX-One MicroKnife® and ultrasound guidance.
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.
Statistically and clinically significant improvements at 1-2 weeks following CTR using the SX-One MicroKnife® and ultrasound guidance.
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 simultaneous bilateral 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 that persisted throughout the study period. In addition, the mean global satisfaction score was 4.6 at all post-operative time points (4 = satisfied, 5 = very satisfied).
Patients reported full use of their hands since the day of the procedure and no complications following CTR with the SX-One MicroKnife® and Ultrasound Guidance.
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.
60% decrease in Cross-sectional Area of the Median Nerve following CTR using the SX-One MicroKnife® and ultrasound guidance.
Post procedure diagnostic US confirmed TCL transection, median nerve palmar displacement, and median nerve CSA improvement from 0.24 cm2 preoperatively to 0.16 cm2 at 1 month and 0.14 cm2 at 3 months (60% decrease in size). At 1-week follow-up, the patient reported significant improvements in night pain, numbness and tingling and forearm pain. His pain score improved from 5 of 10 to 2 of 10, and the incision was well healed. At both 1 and 3-month follow-up, the patient reported 0 of 10 pain and complete symptom resolution. He reported being very satisfied and indicated that he would recommend the procedure to others.
A patient with post-polio syndrome was able to immediately resume crutch weight bearing following bilateral CTR using the SX-One MicroKnife® and ultrasound guidance.
After 12 weeks, the patient’s BCTQ symptom score improved by 2.0 (left) and 1.62 (right). The functional score improved by 1.25 (left) and 1.37 (right). The QDASH score improved by 52.27 points (left) and 34.09 points (right). At 4 weeks after each release, the patient reported complete resolution of symptoms and being very satisfied with the results on both sides. The patient was able to immediately resume crutch weight-bearing following each of the staggered bilateral CTR procedures using the SX-One MicroKnife and ultrasound guidance.