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.
CTR with ultrasound guidance was initially described by Nakamichi in 1997.11,15 Since then, 580 clinical cases have been reported in peer reviewed literature. There have been no reported neurovascular complications and the collective clinical success rate is over 97%.10
Prospective randomized trial comparing CTR using ultrasound guidance to traditional mini-OCTR without ultrasound guidance demonstrated that patients treated with CTR with ultrasound guidance recovered faster.
Rojo-Manaute JM, Capa-Grasa A, et al. Ultra-minimally invasive sonographically guided carpal tunnel release: a randomized clinical trial. J Ultrasound Med. 2016;37:e37-45.
The first CTR using the SX-One MicroKnife® and ultrasound guidance was performed February 17, 2017.
Results:
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.
Results:
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).
Results:
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.
Results:
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.
Results:
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.
Read a summary of scientific presentations reporting results using the SX-One MicroKnife.