Sonex Health Medical Reference List August 2018

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Sonex Health Medical Reference List August 2018 Highlighted Articles Pertain to the SX-One MicroKnife Boldface Links are Publicly Available Via the Internet Clinical Publications Ultrasound Guided

1 Sonex Health Medical Reference List August 2018 Highlighted Articles Pertain to the SX-One MicroKnife Boldface Links are Publicly Available Via the Internet Clinical Publications Ultrasound Guided Carpal Tunnel Release 1. Buncke, G., B. McCormack, et al. (2013). "Ultrasound-guided carpal tunnel release using the MANOS CTR system." Microsurgery 33(5): Capa-Grasa, A., J. M. Rojo-Manaute, et al. (2014). "Ultra-minimally invasive sonographically guided carpal tunnel release: an external pilot study." Orthopaedics & Traumatology, Surgery & Research 100(3): PURPOSE: Authors have reported better outcomes, by reducing surgical dissection for carpal tunnel syndromes requiring surgery. Recently, a new sonographically guided technique for ultra-minimally invasive (Ultra-MIS) carpal tunnel release (CTR) through 1mm incision has been described. We hypothesized that a clinical trial for comparing Ultra-MIS versus Mini-open Carpal Tunnel Release (Mini- OCTR) was feasible. METHODS: To test our hypothesis, we conducted a pilot study for studying Ultra- MIS versus Mini-OCTR respectively performed through a 1mm or a 2 cm incision. We defined success if primary feasibility objectives (safety and efficacy) as well as secondary feasibility objectives (recruitment rates, compliance, completion, treatment blinding, personnel resources and sample size calculation for the clinical trial) could be matched. Score for Quick-DASH questionnaire at final follow-up was studied as the primary variable for the clinical trial. Turnover times were studied for assessing learning curve stability. RESULTS: Forty patients were allotted. Primary and secondary feasibility objectives were matched with the following occurrences: 70.2% of eligible patients finally recruited; 4.2% of randomization refusals; 26.6 patients/month recruited; 100% patients receiving a blinded treatment; 97.5% compliance and 100% completion. A sample size of 91 patients was calculated for clinical trial validation. At final follow-up, preliminary results for Quick-Dash substantially favored Ultra-MIS over Mini-OCTR (average versus 7.39) and complication rates were lower for Ultra-MIS (5% versus 20%). A stable learning curve was observed for both groups. CONCLUSIONS: The clinical trial is feasible. There is currently no evidence to contraindicate nor withhold the use of Ultra-MIS for CTR 3. Chern, T. C., K. C. Wu, et al. (2014). "A cadaveric and preliminary clinical study of ultrasonographically assisted percutaneous carpal tunnel release." Ultrasound Med Biol 40(8): ABSTRACT: The aim of this study was to assess the effectiveness and safety profile of a new technique for ultrasonographically assisted percutaneous carpal tunnel release. Experiments were performed on 40 hands in 20 cadavers. We first performed a detailed ultrasonographic examination and correlation study that included surgical dissection of the transverse carpal ligament, the related neurovascular structures and the bony landmarks of the radiocarpal, midcarpal and carpometacarpal joints of the right hand. We then used the measurements we made for percutaneous carpal tunnel release of the transverse carpal ligament using intra-operative ultrasonography for guidance and a hook knife on the left-hand side. The completeness of the release and the potential risks of injury to the flexor tendon and neurovascular bundles were examined. Using real-time intra-operative ultrasonographic monitoring to clearly delineate these targets, we were able to percutaneously release the transverse carpal ligament completely in 18 (90%) of the 20 hands and partially release it in 2 without injuring any neurovascular bundles. We then performed 1

2 the procedure on 91 consecutive cases of carpal tunnel syndrome and found that the sensory disturbances disappeared in 100% patients 12 mo post-operatively; only 2 hands were graded as unsatisfactory. There were no intra- or post-operative complications. Based on the results from the cadaveric studies and our successful preliminary clinical outcomes, we conclude that this method is tolerable and that its clinical application can be encouraged. 4. Chern, T.C., K. Li-Chieh, et al. (2015). "Ultrasonographically guided percutaneous carpal tunnel release: Early clinical experiences and outcomes." Arthroscopy 31: PURPOSE: To present the technique and results of ultrasonographically guided percutaneous carpal tunnel release (PCTR) in a consecutive series of patients with carpal tunnel syndrome (CTS). METHODS: We used previously defined landmarks with the "safe zones," localization, estimated size, and extent of the transverse carpal ligament (TCL) for this prospective clinical study of 91 consecutive cases of carpal tunnel release treated with this technique. The follow-up consisted of 4 time points (1 week and 2, 6, and 12 months) and a final evaluation at an average of 22.5 months. RESULTS: The sensory disturbances disappeared in 76.8%, 93.4%, 100%, and 100% of the patients at 1 week and 2, 6, and 12 months postoperatively, respectively. Moderate pain was experienced in 24.2% of patients within 1 week, in 6.6% of patients within 2 months, and in 1.1% of patients within 12 months after the operation. In the final evaluation, 2 hands were graded as unsatisfactory: one hand had moderate wrist pain without sensory disturbance, and one hand had a recurrence 14 months after the operation. There were no intraoperative or postoperative complications. CONCLUSIONS: Ultrasonographically assisted PCTR is a safe and effective procedure, but it is technically demanding and requires substantial training to be proficient in its use. 5. Guo, D., D. Guo, et al. (2017). "A clinical study of the modified thread carpal tunnel release." Hand 12(5): Guo, D., Y. Tang, et al. (2015). "A non-scalpel technique for minimally invasive surgery: percutaneously looped thread transection of the transverse carpal ligament." Hand 10: Henning, P.T., L. Yang, et al. (2018). "Minimally invasive ultrasound-guided carpal tunnel release: Preliminary clinical results." J Ultrasound Med (in press, epub ahead of print April 2, 2018, DOI: ABSTRACT: Ultrasound guided carpal tunnel release was performed on 14 patients (18 wrists) using dynamic expansion of the transverse safe zone. Our patient population included able bodied patients and those with impairments. The first 8 cases (12 wrists) underwent the procedure in an operating room, the remainder in an outpatient setting. No complications occurred, and all patients were able to immediately resume use of their hands without therapy. Improvements in the Quick Form of the Disabilities of the Arm, Shoulder, and Hand Index and Boston Carpal Tunnel Questionnaire at 3 months were comparable to results reported with mini open and endoscopic release. Our results show that ultrasound guided carpal tunnel release can be safely and effectively performed in an outpatient setting. 8. Henning, T., D. Lueders, et al. (2018). "Ultrasound-guided carpal tunnel release using dynamic expansion of the transverse safe zone in a patient with postpolio syndrome: a case report." PM&R (in press, epub ahead of print March 5, 2018, DOI: 2

3 ABSTRACT: The prevalence of carpal tunnel syndrome (CTS) in patients with postpolio syndrome occurs at a rate of 22%. Irrespective of those with CTS, 74% of postpolio patients weight bear through their arms for ambulation or transfers. As open carpal tunnel release is performed along the weight-bearing region of the wrist, their functional independence may be altered while recovering. This case demonstrates that ultrasound-guided carpal tunnel release was successfully performed in a patient with postpolio syndrome allowing him to immediately weight bear through his hands after the procedure so he could recover at home. 9. Latzka, E.W., P.T. Henning, et al. (2018). "Sonographic changes after ultrasound-guided release of the transverse carpal ligament: a case report." PM&R (in press, epub ahead of print March 6, 2018, DOI: ABSTRACT: Carpal tunnel syndrome is the most common entrapment neuropathy, resulting in 500,000 carpal tunnel release (CTR) surgeries and a total cost of more than 2 billion dollars annually in the United States. Although initially performed via a large (3-5 cm) palmar incision, CTR techniques have continually evolved to reduce recovery times and postoperative pain and improve cosmesis and clinical outcomes. More recently, multiple authors have reported excellent results after ultrasound-guided carpal tunnel release (USCTR) using a variety of techniques, and one prospective randomized trial reported faster recovery after USCTR compared with traditional mini-open CTR. However, there is a paucity of data with respect to changes in the median nerve after USCTR. This case report presents the functional outcomes and pre- and postprocedure ultrasound images of a patient after USCTR with 3-month follow-up. 10. Lecoq, B., N. Hanouz, et al. (2015). "Ultrasound-assisted surgical release of carpal tunnel syndrome: results of a pilot open-label uncontrolled trial conducted outside of the operating theatre." Joint Bone Spine 82: Markison, R. E. (2013). "Percutaneous ultrasound-guided MANOS carpal tunnel release technique." Hand 8(4): McShane, J. M., S. Slaff, et al. (2012). "Sonographically guided percutaneous needle release of the carpal tunnel for treatment of carpal tunnel syndrome: preliminary report." J Ultrasound Med 31: Nakamichi, K., S. Tachibana, et al. (2010). "Percutaneous carpal tunnel release compared with mini-open release using ultrasonographic guidance for both techniques." J Hand Surgery 35A(3): PURPOSE: To compare the outcomes of percutaneous carpal tunnel release (PCTR) and mini-open carpal tunnel release (mini-octr) using ultrasonographic guidance for both techniques. METHODS: We included 74 hands of 65 women with idiopathic carpal tunnel syndrome (age, y; mean, 58 y). Thirtyfive hands of 29 women had the PCTR (release with a device consisting of an angled blade, guide, and holder, along a line midway between the median nerve and ulnar artery (safe line) under ultrasonography (incision, 4 mm), and 39 hands of 36 women had the mini-octr (release along the safe line, distally under direct vision (incision, cm) and proximally under ultrasonography, using a device consisting of a basket punch and outer tube. RESULTS: Assessments at 3, 6, 13, 26, 52, and 104 weeks showed no significant differences in neurologic recovery between the groups (p >.05). The PCTR group had significantly less pain, greater grip and key-pinch strengths, and better satisfaction scores at 3 and 6 weeks (p <.05), and less scar sensitivity at 3, 6, and 13 weeks (p <.05). There were no complications. CONCLUSIONS: The PCTR provides the same neurologic recovery as does the mini-octr. The former 3

4 leads to less postoperative morbidity and earlier functional return and achievement of satisfaction. LEVEL OF EVIDENCE: Therapeutic III. 14. Nakamichi K, T. S. (1997). "Ultrasonographically assisted carpal tunnel release." J Hand Surg 22A: Petrover, D., J. Silvera, et al. (2017). "Percutaneous ultrasound-guided carpal tunnel release: study upon clinical efficacy and safety." Cardiovasc Intervent Radiol 40(4): PURPOSE: To evaluate the feasibility and 6 months clinical result of sectioning of the transverse carpal ligament (TCL) and median nerve decompression after ultra-minimally invasive, ultrasound-guided percutaneous carpal tunnel release (PCTR) surgery. METHODS: Consecutive patients with carpal tunnel syndrome were enrolled in this descriptive, open-label study. The procedure was performed in the interventional radiology room. Magnetic resonance imaging was performed at baseline and 1 month. The Boston Carpal Tunnel Questionnaire was administered at baseline, 1, and 6 months. RESULTS: 129 patients were enrolled. Significant decreases in mean symptom severity scores (3.3 ± 0.7 at baseline, 1.7 ± 0.4 at Month 1, 1.3 ± 0.3 at Month 6) and mean functional status scores (2.6 ± 1.1 at baseline, 1.6 ± 0.4 at Month 1, 1.3 ± 0.5 at Month 6) were noted. Magnetic resonance imaging showed a complete section of all TCL and nerve decompression in 100% of patients. No complications were identified. CONCLUSIONS: Ultrasound-guided PCTR was used successfully to section the TCL, decompress the median nerve, and reduce self-reported symptoms. 16. ***Rojo-Manaute, J. M., A. Capa-Grasa, et al. (2016). "Ultra-minimally invasive sonographically guided carpal tunnel release: a randomized clinical trial." J Ultrasound Med 35(6): ABSTRACT: The purpose of this study was to compare the outcomes of 1-mm ultra minimally invasive ultrasound-guided carpal tunnel release and 2-cm blind mini open carpal tunnel release. METHODS : We conducted a single-center individual parallel-group controlled-superiority randomized control trial in an ambulatory office-based setting at a third-level referral hospital. Eligible participants had clinical signs of primary carpal tunnel syndrome and positive electrodiagnostic test results and were followed for 12 months. Independent outcome assessors were blinded. Patients were randomized by concealed allocation (1:1) by an independent blocked computer-generated list. The postoperative score on the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire was the primary variable. Grip strength and time for discontinuation of oral analgesics, complete wrist flexion-extension, relief of paresthesia, and return to normal daily activities (including work) were assessed. RESULTS: Ninety-two of 128 eligible patients were randomly allocated and analyzed. QuickDASH scores were 2.2 to 3.3 times significantly lower in the ultra minimally invasive group for the first 6 months: 23.6 [95% confidence interval (CI), 20.5, 27.4] versus 52.6 [95% CI, 49.4, 57.0] at the first week and 4.09 [95% CI, 1.5, 7.1] versus 13.0 [95% CI, 9.4, 18.9] at 6 months. Return to normal daily activities occurred significantly sooner in the ultra minimally invasive group: 4.9 [95% CI, 3.2, 6.5] versus 25.4 [95% CI, 18.2, 32.6] days. CONCLUSIONS: Ultra minimally invasive carpal tunnel release provides earlier functional return and less postoperative morbidity with the same neurologic recovery as mini open carpal tunnel release for patients with symptomatic primary carpal tunnel syndrome. 4

5 Anatomical Studies - Ultrasound Guided Carpal Tunnel Release 1. Burnham R., et al. (2017). "Evaluation of the effectiveness and safety of ultrasound guided percutaneous carpal tunnel release: a cadaveric study." Am J Phys Med Rehabil 96(7): Chern, T. C., I. M. Jou, et al. (2009). "An ultrasonographic and anatomical study of carpal tunnel, with special emphasis on the safe zones in percutaneous release." J Hand Surg 34E(1): ABSTRACT: We examined 40 wrists of 12 embalmed and eight fresh cadavers and defined the relative position of the flexor retinaculum to the neurovascular structure, ultrasonographic markers and safe zones by ultrasonography and anatomical dissection. Both longitudinal and transverse ultrasonographic sections clearly depicted the flexor retinaculum, neurovascular bundles, median nerve, flexor tendons and bony boundaries of the underlying joints. Topographic measurement showed [i] good correlation between the actual extent of the flexor retinaculum and the ultrasonographically determined distance between bony landmarks in all hands, and [ii] the widths and lengths of well-defined safe zones. A comparison study confirmed the accuracy of ultrasonography. We conclude that these ultrasonographic landmarks can locate the flexor retinaculum and facilitate safe and complete carpal tunnel release with open or minimally invasive techniques. 3. de la Fuente, J., M. I. Miguel-Perez, et al. (2013). "Minimally invasive ultrasound-guided carpal tunnel release: a cadaver study." J Clin Ultrasound 41(2): Guo, D., D. Guo, et al. (2016). "A cadaveric study for the improvement of thread carpal tunnel release." J Hand Surgery Am 41(10): e Hebbard, P.D., A.I.T., Hebbard, et al. (2018). "Ultrasound-guided microinvasive carpal tunnel release using a novel retractable needle-mounted blade: a cadaveric study." J Ultrasound Med (in press, epub ahead of print February 16, 2018, DOI: 6. Lecoq, B., N. Hanouz, et al. (2011). "Ultrasound-guided percutaneous surgery for carpal tunnel syndrome: a cadaver study." Joint Bone Spine 78(5): Rojo-Manaute, J. M., A. Capa-Grasa, et al. (2013). "Ultra-minimally invasive sonographically guided carpal tunnel release: anatomic study of a new technique." J Ultrasound Med 32: Rowe, N.M., J. Michaels V, et al. (2005). "Sonographically guided percutaneous carpal tunnel release: an anatomic and cadaveric study" Ann Plast Surg 55:

6 Role of Ultrasound in Carpal Tunnel Syndrome 1. Beckman, J.P., J.L. Sellon, et al. (2018). "Sonographically detected transligamentous median nerve branch." Am J Phys Med Rehabil (in press, epub ahead of print January 4, 2018, DOI: CONCLUSION: The current case demonstrates the ability of ultrasound (US) to detect a transligamentous median nerve branch during prescreening for ultrasound-guided carpal tunnel release. Clinically, this finding provides additional evidence that high resolution US is able to detect important anatomic variants, such as transligamentous median nerve branches, that may alter clinical and surgical decision-making in patients presenting with carpal tunnel syndrome. Accordingly, US protocols for carpal tunnel syndrome should include specific screening for transligamentous median nerve branches. 2. Cartwright, M.S., L. D. Hobson-Webb, et al. (2012). "Evidence-based guideline: neuromuscular ultrasound for the diagnosis of carpal tunnel syndrome." Muscle & Nerve 46: DX-of-CTS-for-web.pdf 3. Fowler, J.R., M. Munsch, et al. (2014). "Comparison of ultrasound and electrodiagnostic testing for diagnosis of carpal tunnel syndrome: study using a validated clinical tool as the reference standard." J Bone Joint Surg 96A(17): e _Comparison_of_Ultrasound_and_Electrodiagnostic_Testing_for_Diagnosis_of_CTS. pdf 4. Fowler, J.R., W. Cipolli, T. Hanson (2015). "A comparison of three diagnostic tests for carpal tunnel syndrome using latent class analysis." J Bone Joint Surg 97A(23): PURPOSE: The current reference standard for carpal tunnel syndrome is under debate. Recent studies have demonstrated similar diagnostic accuracy between ultrasound and nerve conduction studies. The purpose of the present study was to determine the sensitivity and specificity of ultrasound, nerve conduction studies, and Carpal Tunnel Syndrome 6 (CTS-6) for the diagnosis of carpal tunnel syndrome using latent class analysis. METHODS: Latent class analysis is a statistical technique that can be used to estimate the accuracy of diagnosis when there is no universally accepted reference standard. This type of analysis is useful in the setting of carpal tunnel syndrome as there remains substantial controversy with respect to the necessity of nerve conduction studies and other confirmatory testing. CTS-6 is a validated clinical diagnostic tool for the diagnosis of carpal tunnel syndrome that has been shown to have a high sensitivity and specificity. Data from a database on the cases of eighty-five consecutive patients who had had nerve conduction studies, CTS-6, and ultrasound were analyzed using classical latent class analysis, assuming that the three tests were imperfect and conditionally independent. RESULTS: The sensitivities of ultrasound, CTS-6, and nerve conduction studies were 91% (95% confidence interval [CI], 81% to 98%), 95% (95% CI, 86% to 99%), and 91% (95% CI, 81% to 97%), respectively. The specificities of ultrasound, CTS-6, and nerve conduction studies were 94% (95% CI, 80% to 100%), 91% (95% CI, 74% to 99%), and 83% (95% CI, 66% to 95%), respectively. CONCLUSIONS: Ultrasound, nerve conduction studies, and CTS-6 have similar sensitivity and specificity for the diagnosis of carpal tunnel syndrome. The currently accepted reference standard (nerve conduction studies) had the lowest sensitivity and specificity of the three tests. These findings support previous studies that have suggested that CTS-6 and ultrasound are highly accurate in the diagnosis of carpal tunnel syndrome and that nerve conduction studies are not necessary in most cases. 6

7 5. Petrover, D., J. Bellity, et al. (2017). "Ultrasound imaging of the thenar motor branch of the median nerve: a cadaveric study." Eur Radiol 27(11): Riegler, G., C. Pivec, et al. (2017). "High-resolution ultrasound visualization of the recurrent motor branch of the median nerve: normal and first pathological findings." Eur Radiol 27(7): Smith, J., D.E. Barnes, et al. (2017). "Sonographic visualization of the thenar motor branch of the median nerve: a cadaveric validation study." PM&R 9(2): ABSTRACT: The thenar motor branch (TMB) of the median nerve may be affected in carpal tunnel syndrome and can be injured during carpal tunnel surgery. Although ultrasound has been used to identify small nerves throughout the body, the sonographic evaluation of the TMB has not been investigated formally. METHODS: On the basis of anatomical descriptions, dissection and clinical experience, a technique was developed to sonographically identify the presumed TMB of the median nerve at the distal carpal tunnel. A single, experienced examiner then identified the presumed TMB in 10 unembalmed, cadaveric upper limb specimens (4 right, 6 left) obtained from 9 donors (4 male, 5 female) ages years with body mass indices of kg/m2 with both 12-3 MHZ and 16-7 MHz linear array transducers. The same examiner then injected ml of diluted colored latex into and around the presumed TMB using direct ultrasound guidance. At a minimum of 24 hours postinjection, specimens were dissected under loupe magnification to determine the location of the latex injectate. RESULTS: A vertical, linear, hypoechogenic region was sonographically identified arising from the median nerve at the distal carpaltunnel in all 10 specimens and was hypothesized to represent the vertical segment of the TMB. Both transducers allowed identification of the TMB, although localization was subjectively facilitated by the higher frequency transducer. All 10 sonographically guided injections placed latex into and around the TMB of the median nerve, confirming that ultrasound had accurately identified the TMB. CONCLUSIONS: Sonographic evaluation of the TMB of the median nerve is technically feasible and should be considered when clinically indicated. Further research and clinical experience is necessary to define the role of sonographic TMB imaging in the evaluation and management of patients with carpal tunnel syndrome. 8. Tagliafico, A., F. Pugliese, et al. (2008). "High-resolution sonography of the palmar cutaneous branch of the median nerve." AJR. Am J Roentgenol 191(1): Torres-Costoso, A., V. Martínez-Vizcaíno, et al. (2018). "Accuracy of ultrasonography for the diagnosis of carpal tunnel syndrome: a systematic review and meta-analysis." Arch Phys Med Rehabil 99(4): e10. AAOS Guidelines on the Evaluation and Management of Carpal Tunnel Syndrome 1. Graham, B., A.E. Peljovich, et al. (2016). "The American Academy of Orthopaedic Surgeons Evidence-Based Clinical Practice Guideline on: Management of Carpal Tunnel Syndrome." J Bone Joint Surg 98A(20):

Jay Smith, M.D. Chief Medical Officer and Founder, Sonex Health LLC March 2018

SX-One MicroKnife Ultrasound Guided Carpal Tunnel Release: Initial Clinical Experience Jay Smith, M.D. Chief Medical Officer and Founder, Sonex Health LLC March 2018 Introduction Carpal tunnel syndrome