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.

Clinical results of carpal tunnel release using ultrasound guidance in over 100 patients at two to six years.

Logan Cano, Braeden M. Leiby, Laura C. Shum, Meliza G. Ward, Anthony E. Joseph
Journal of Hand Surgery Global Online, 2024, ISSN 2589-5141, Published 2024 Mar 4. https://doi.org/10.1016/j.jhsg.2024.02.004

Case series reporting the results of 102 patients/162 hands at a minimum of 2-years following carpal tunnel release using ultrasound guidance (CTR-US) and UltraGuideCTR performed by a single physician in a community-based practice. Over 50% of the patients were treated with simultaneous bilateral releases. At a mean final follow-up of 46 months (range 2-6 years) BCTQ-SSS/-FSS and QDASH scores remained significantly improved vs. baseline (P<0.001) and improvements exceeded minimal clinically important differences. Mean patient satisfaction scores were 4.6 (1-5 scale) with 91.2% of patients reported being satisfied or very satisfied with the procedure. There were no re-operations for recurrence.  Results were similar for patients treated with unilateral vs. simultaneous bilateral releases.

Final 1-Year Results of the TUTOR Randomized Trial Comparing Carpal Tunnel Release with Ultrasound Guidance to 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
Plastic and Reconstructive Surgery Global Open. 2024;12(3):e5665. Published 2024 Mar 4. doi:10.1097/GOX.0000000000005665. PMID: 38440365; PMCID: PMC10911521.

One-year results of a multicenter, prospective randomized trial of CTR-US using UltraGuideCTR vs. mOCTR. Primary purpose was to report the final, one-year outcomes in follow-up to the previous publication of Eberlin et al. (Expert Rev Med Devices 2023). One-year follow-up was available in 80/94 and 27/28 subjects treated with CTR-US and mOCTR, respectively.  At 1-year, mean improvements in BCTQ-SSS/-FSS, numerical pain, and EQ-5D-5L scores remained significantly improved vs. baseline (P<0.001) and exceeded minimal clinically important differences. 95% of CTR-US subjects reported satisfaction with the procedure vs. 92.6% of mOCTR subjects. Incisions were significantly smaller for the CTR-US group (mean 6mm in the wrist vs. 22 mm in the palm, P<0.001) and at year significantly more CTR-US subjects reported freedom from scar pain or sensitivity (95% vs. 74.1%, P=0.005). There were no recurrences or late complications in either group.

Early Return to Work after Carpal Tunnel Release with Ultrasound Guidance

Paul D. Paterson, Matthew J. Kirsch, Larry E. Miller, Demetrio J. Aguila, III
Plastic and Reconstructive Surgery Global Open. 2024;12(2):e5647. Published 2024 Feb 27. doi:10.1097/GOX.0000000000005647.

Case series from the APEX-CTR multicenter, post-market registry reporting return to work (RTW) for 544 patients/655 hands treated with CTR-US using UltraGuideCTR at 24 centers. In this real-world, pragmatic study, over half of patients (52%) had symptoms for >2 years and there were no restrictions based on maximum patient age, comorbidities (e.g., anxiety 21%, depression 19%, thyroid disease 12%) or tobacco use status (12% current tobacco use). All patients were employed at the time of surgery (49% desk-based, 28% light-manual, 23% heavy manual), with 45% reporting regular lifting of 20lbs or more, 19% reporting regular use of vibrating equipment and 18% reporting regular use of heavy equipment. Median RTW was 3 days and was 2-4 days for all job duty groups, including heavy manual laborers. Males and those in desk-based positions had a statistically significantly higher chance of returning to work within 5 days (P=0.01 and P<0.001, respectively). Complications included 2 deep infections, 2 revisions for persistent symptoms and one suspected tendon injury lost to follow-up (some complications were also reported in previous publications from the same registry).

Office-Based Carpal Tunnel Release With Ultrasound Guidance: 6-month Outcomes From the Multicenter ROBUST Trial

Ashley L. Pistorio, Victor M. Marwin, Paul D. Paterson, Randall D. Alexander, Johnny T. Nelson, Larry E. Miller
Journal of Hand Surgery Global Online, 2024, ISSN 2589-5141, https://doi.org/10.1016/j.jhsg.2023.12.005.

Six-month results of a prospective, multicenter, observational study reporting clinical outcomes of 149 subjects/226 hands treated with CTR-US using UltraGuideCTR in an office-based setting. All procedures were completed in the office using only local anesthesia (79% with epinephrine), >50% of subjects had simultaneous bilateral releases, and 3 of the 7 hand surgeons had no previous experience performing CTR-US in the office setting. All procedures were completed as planned, the mean intra-operative pain score was 1.9 (79% of subjects identified the needle stick as most painful), the mean incision length was 5 mm, and over 98% of wounds were closed without sutures. Median return to normal daily activities was 2 days and median return to work was 4 days (104 employed subjects), including heavy manual laborers. BCTQ-SSS/-FSS, MHQ, pain, and EQ-5D-5L scores rapidly improved and at 6-months remained significantly improved vs. baseline (P<0.001) and exceeded minimal clinically important differences.  94% of subjects were satisfied at 6 months and results were similar for simultaneous bilateral vs. unilateral procedures.  No infections or revision surgeries for persistent or recurrent symptoms. One subject with increased paresthesias was explored, treated for a nerve contusion with a small epineurial injury, and had “complete recovery of median nerve function and minimal residual ring finger tingling” at 7 weeks.

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

Demetrio Aguila, Matthew Kirsch, Brett Kindle, Paul Paterson
Journal of Hand Surg Glob Online. 2023 Nov 22;6(1):79-84. doi: 10.1016/j.jhsg.2023.10.001. PMID: 38313613; PMCID: PMC10837292.

Reports the final, 1-year results from the APEX-CTR post-market registry in follow-up to the previous publication of Fowler et al. (Expert Rev Med Devices 2022).  300 patients/341 hands had both pre-operative and 1-year post-operative data following CTR-US using UltraGuideCTR performed by 25 different physicians.  At 1-year post-CTR-US, BCTQ-SSS/-FSS and QDASH scores remained significantly improved vs. baseline (P<0.001) and improvements exceeded minimal clinically important differences. 87.7% of patients were satisfied with the procedure, and the mean procedure recommendation score was 8.9 (0-10 scale). Females had a quantitatively small but statistically significantly greater improvement in BCTQ and QDASH scores. No other factors, including treatment with simultaneous releases or concomitant procedures (e.g., trigger finger release, cubital tunnel release), significantly affected 1-year outcomes. Complications included two revisions (one of which was also reported in Fowler et al.), 1 deep infection and 1 suspected tendon injury lost to follow-up.

Carpal Tunnel Release With Ultrasound Guidance: Intermediate-Term Clinical Outcomes and Magnetic Resonance Imaging Findings

Grace E. Nicholas, Jen Galloway, Jennifer Hawley, Joseph C. McGinley
Journal of Hand Surgery Global Online, 2023 Jun 7;5(5):595-600. doi: 10.1016/j.jhsg.2023.05.002. PMID: 37790816; PMCID: PMC10543793.

Consecutive case series of 65 patients/96 hands treated with CTR-US using UltraGuideCTR in a procedure room setting, including 13 patients/17 hands with pre- and post-operative MRI scans at a mean of 3 months post-op. No complications. Statistically significant improvements in BCTQ and QDASH scores occurred by 2 weeks, were maintained at 3–6-month follow-up, and exceeded minimal clinically important differences. All 38 employed patients with return to work data had returned to work by 2 weeks, including 21 manual laborers. MRI revealed complete TCL transection in all 17 wrists, and statistically significant changes in MRI parameters consistent with carpal tunnel decompression – 22% increase in carpal tunnel cross sectional area at the hamate, 52% increase in median nerve cross sectional area at the hamate, 18% reduction in median nerve T2 signal intensity, and 38% reduction in median nerve flattening (i.e., flattening ratio).

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
Expert Review of Medical Devices. 2023;20(7):597-605. doi:10.1080/17434440.2023.2218548.

Three-month outcomes of a multicenter, prospective randomized trial of CTR-US using UltraGuideCTR vs. mOCTR. Both procedures at each site were performed by the same surgeon. Surgeon experience was significantly greater for mOCTR (median 1,000 procedures) vs. CTR-US (median 12 procedures). Thirteen patients randomized to mOCTR refused treatment and 46 declined to consent due to the possibility of randomization to mOCTR. Post-operative care was standardized. Mean incision length (6 mm vs. 22 mm) and freedom from wound sensitivity (61% vs. 18%) favored CTR-US. Both groups experienced statistically significant and clinically meaningful improvements in BCTQ, pain, and Euro-QOL scores, with no significant differences between the groups. The adverse event rate was also similar between the two groups (2.1% CTR- US vs. 3.6%).

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 following CTR-US using UltraGuideCTR. All procedures 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-US 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 following CTR-US using UltraGuideCTR. 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 had 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 following CTR-US using UltraGuideCTR. 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 simultaneous bilateral 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 following CTR-US using UltraGuideCTR. All procedures 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-US using UltraGuideCTR. 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 treated with CTR-USusing UltraGuideCTR, 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.

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 hands in 14 patients following CTR-US using UltraGuideCTR, including several patients with disabilities who were able to immediately use their crutches and wheelchairs. Multiple procedures 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-US using UltraGuideCTR.

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-US using UltraGuideCTR.