ULTRASOUND GUIDED CTR

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1 ULTRASOUND GUIDED CTR What Every Clinician Should Know Jay Smith, M.D. Departments of PM&R, Radiology & Anatomy Mayo Clinic Sports Medicine Center UPMC Sports Ultrasound Course September MFMER slide-1

2 Disclosure Sonex Health CMO & Board of Directors License agreement Royalties Patent Tenex Health License agreement Royalties Patent 2015 MFMER slide-2

3 Learning Objectives Define the challenge of CTS and CTR Discuss the history of USCTR Review technical considerations for USCTR Sonoanatomy Techniques Summarize the literature pertaining to USCTR Conclusions and future 2015 MFMER slide-3

Challenge of CTS and CTR Most common entrapment neuropathy 2-4% general population 7% manual laborers 500,000 CTRs performed annually 70-80% minioctr 2-3 cm incision Leading cause of workplace

4 Challenge of CTS and CTR Most common entrapment neuropathy 2-4% general population 7% manual laborers 500,000 CTRs performed annually 70-80% minioctr 2-3 cm incision Leading cause of workplace absence Many out of work 4-6 weeks Bilateral symptoms common Significant economic implications 2 billion/yr Foster Hand 2017; Zhang JBJS 2016; Park JAAOS 2016; Dale Scand J Work Environ Health 2013; Fajardo JHS MFMER slide-4

Challenge of CTS and CTR Desire to reduce morbidity less

cosmesis, faster recovery Concerns regarding limited field of

5 Challenge of CTS and CTR Desire to reduce morbidity less invasive OCTR (>4-5 cm) minioctr (2-4 cm) smaller Implications of reduced direct visualization? ECTR (1-2 cm), single or double portal Reduced pain, improved cosmesis, faster recovery Concerns regarding limited field of view - Increase complication rate (at least early on) Vasiliadis Plos One MFMER slide-5

6 Challenge of CTS and CTR Ultrasound provides the solution: Exquisite soft tissue detail Dynamic, including Doppler Better field of view than minioctr or ECTR! 2015 MFMER slide-6

In 1998 introduced transverse safe zone (TSZ) P H T

7 USCTR: History First reported by Nakamichi in 1997 Ultrasound-assisted mini-open Transverse safe line In 1998 introduced transverse safe zone (TSZ) P H T S Nakamichi J Hand Surg 1997, MFMER slide-7

USCTR: History 23 publications (1997-2018) 8

8 USCTR: History 23 publications ( ) 8 cadaveric (N=195 wrists) 15 clinical (N= 641 wrists) 8 prospective 1 prospective semi-randomized 1 prospective randomized Various techniques Entry site Tools Cut direction Chern J Hand Surg 2009, Arthroscopy MFMER slide-8

9 USCTR: Technical Considerations 2015 MFMER slide-9

10 USCTR: Technical Considerations Identify anatomy Place cutting device TSZ LSZ (longitudinal) Check position Cut the TCL Confirm release Remove device P H T S 2015 MFMER slide-10

11 USCTR: Technical Considerations Median nerve PCB TMB/RMB 3 rd CPD Ulnar nerve & vessels Artery and SPA 4 th CPD Variations Beckman AJPMR 2018; Henry PLos One th P SPA 3rd UA H TCL MN T TMB S PCB 2015 MFMER slide-11

12 USCTR: Technical Considerations Palmar cutaneous branch median nerve Tagliafico AJR MFMER slide-12

13 USCTR: Technical Considerations Thenar motor branch median nerve Smith PMR 2016; Riegler Eur Rad 2016; Petrover Eur Rad MFMER slide-13

14 USCTR: Technical Considerations * Third common palmar digital nerve 2015 MFMER slide-14

15 USCTR: Technical Considerations Superficial palmar arterial arch 2015 MFMER slide-15

16 USCTR: Technical Considerations Transverse safe zone MN to UA or Hamate Wide variation (0-10+) can be < 1 mm Ulnar artery encroachment up to 2-3 mm 2015 MFMER slide-16

17 USCTR: Technical Considerations Longitudinal safe zone distal TCL to SPA Widely variable generally larger more radially Sytsma AJPMR MFMER slide-17

18 USCTR: Example 2015 MFMER slide-18

19 USCTR: Example 2015 MFMER slide-19

20 Evidence: Cadaveric 8 studies, 195 wrists 85 unembalmed, 36 embalmed 104 not specified Complete release > 96% No neurovascular injuries UA MN H See References 2015 MFMER slide-20

Evidence: Clinical 563 patients, 641 wrists No neurovascular

Clinical success > 97% One late recurrence (> 1 yr) Another 711

Traum Surg Res 2014; Rojo-Manaute J Ultrasound Med 2016; Petrover

21 Evidence: Clinical 563 patients, 641 wrists No neurovascular injuries No incomplete releases Mean 12 month f/u (3-25 mo) Clinical success > 97% One late recurrence (> 1 yr) Another 711 cases in 6 published abstracts no complications Capa-Grasa Orthop Traum Surg Res 2014; Rojo-Manaute J Ultrasound Med 2016; Petrover Cardiovasc Intervent Radiol 2016; also, see References 2015 MFMER slide-21

22 Level 1 Evidence: Rojo-Manaute et al. Single surgeon 41 USCTR vs. 41 minioctr 12 month follow up blinded assessment No complications in USCTR group 5X faster return to activity, medication d/c, and relief of paresthesia Rojo-Manaute et al, J Ultrasound Med MFMER slide-22

23 Take Home Points Clinical evidence supports safety and efficacy Multiple users in multiple settings No comparative studies with respect to technique Level 1 evidence USCTR > minioctr Less invasive faster recovery No comparative studies USCTR vs. ECTR Future anticipate increased utilization Challenges Qualifications? operators and machines Change perception of US unparalleled field of view Changing the status quo - disruptive 2015 MFMER slide-23

24 ULTRASOUND GUIDED CTR What Every Clinician Should Know Thank You UPMC Sports Ultrasound Course September MFMER slide-24

25 References Buncke, GB, et al. (2013). "Ultrasound-guided carpal tunnel release using the MANOS CTR system." Microsurgery 33(5): 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, TC, 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): Capa-Grasa, A, et al. (2014). "Ultra-minimally invasive sonographically guided carpal tunnel release: an external pilot study." Orthopaedics & Traumatology, Surgery & Research 100(3): Chern, TC, et al. (2014). "A cadaveric and preliminary clinical study of ultrasonographically assisted percutaneous carpal tunnel release." Ultrasound Med Biol 40(8): Chern TC, et al. (2015) Ultrasonographically guided percutaneous carpal tunnel release: early clinical experiences and outcomes. Arthroscopy 21: MFMER slide-25

26 References Dale AM, et al. (2013). Prevalence and incidence of carpal tunnel syndrome in US working populations: pooled analysis of six prospective studies. Scand J Work Environ Health 39(5): Fajardo M, et al. (2012). Incidence of carpal tunnel release: trends and implications within the United States ambulatory care setting. J Hand Surg. 2012;37: Foster BD, et al. (2017). Surgical approach and anesthetic modality for carpal tunnel release: a nationwide database study with health care cost implications. Hand 12(2): Guo, D, et al. (2017). "A clinical study of the modified thread carpal tunnel release." Hand 12(5): Guo, D. et al. (2015). "A non-scalpel technique for minimally invasive surgery: percutaneously looped thread transection of the transverse carpal ligament." Hand 10: Henning, PT, et al. (2018). "Minimally invasive ultrasound-guided carpal tunnel release: reliminary clinical results." J Ultrasound Med (in press, epub ahead of print April 2, 2018, DOI: MFMER slide-26

27 References Henning, TD, 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: Henry BM, et al. (2015) The prevalence of anatomical variations of the median nerve in the carpal tunnel: a systematic review and meta-analysis. PLoS ONE 10(8): e doi: /journal.pone Latzka, EW., 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: Lecoq, B, 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: Lecoq, B, et al. (2011). "Ultrasound-guided percutaneous surgery for carpal tunnel syndrome: a cadaver study." Joint Bone Spine 78(5): Markison, RE (2013). "Percutaneous ultrasound-guided MANOS carpal tunnel release technique." Hand 8(4): MFMER slide-27

28 References McShane, JM, 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, KS, et al. (2010). "Percutaneous carpal tunnel release compared with mini-open release using ultrasonographic guidance for both techniques." J Hand Surgery 35A(3): Nakamichi KS, et al. (1997). "Ultrasonographically assisted carpal tunnel release." J Hand Surg 22A: Park, KW, et al. (2016). Simultaneous bilateral versus staged bilateral carpal tunnel release: a cost effective analysis. J Am Acad Orthop Surg:25: Petrover, D, et al. (2017). "Percutaneous ultrasound-guided carpal tunnel release: study upon clinical efficacy and safety." Cardiovasc Intervent Radiol 40(4): Petrover, D., et al. (2017). "Ultrasound imaging of the thenar motor branch of the median nerve: a cadaveric study." Eur Radiol 27(11): MFMER slide-28

29 References Riegler, G.C, 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): Rojo-Manaute, JM, et al. (2016). "Ultra-minimally invasive sonographically guided carpal tunnel release: a randomized clinical trial." J Ultrasound Med 35(6): Rojo-Manaute, JM, et al. (2013). "Ultra-minimally invasive sonographically guided carpal tunnel release: anatomic study of a new technique." J Ultrasound Med 32: Rowe, NM, et al. (2005). "Sonographically guided percutaneous carpal tunnel release: an anatomic and cadaveric study" Ann Plast Surg 55: Smith, J, et al. (2017). "Sonographic visualization of the thenar motor branch of the median nerve: a cadaveric validation study." PM&R 9(2): Vasiliadis, HS, et al. (2015): Endoscopic and open release similarly safe for the treatment of carpal tunnel syndrome: a systematic review and meta-analysis. PLoS ONE 10(12):e doi: /journal.pone MFMER slide-29

30 References Zhang, S, et al. (2016). Cost minimization analysis of open and endoscopic carpal tunnel release. J Bone Joint Surg Am 98(23): MFMER slide-30

WHAT CAN ULTRASOUND SEE IN THE CARPAL TUNNEL REGION?

WHAT CAN ULTRASOUND SEE IN THE CARPAL TUNNEL REGION? Jay Smith, M.D. CMO, Sonex Health LLC June 2017 Modern day ultrasound (US) machines provide a powerful combination of submillimeter resolution and dynamic