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Clinical Data

MANOS™ Research and Clinical Affairs

Thayer™ currently has two clinical research projects underway:

52 Patient Retrospective Analysis:
52 patients from Frank Howard Memorial Hospital (Willits, CA) who had carpal tunnel release performed with the MANOS Carpal Tunnel Release System, have consented to a validated outcome questionnaire for the purpose of collecting data on hand functionality postoperatively. Written by Dr. Bruce M. McCormack, Dr. William Bowen, Dr. Stephen Gunther, Dr. Michael Kaplan, and Dr. Edward Eyster, the authors have submitted the retrospective analysis for review and are anticipating that it will be published soon. The data is encouraging; indicating that results from carpal tunnel release surgery with MANOS is comparable to endoscopic results. This data is based on a retrospective review, and as a result is being validated with a prospective, single-arm, open enrollment clinical study.

100 Patient Prospective, Single-Arm, Open Enrollment Clinical Study:
Approximately 100 patients will be enrolled at three sites; St. Francis Memorial Hospital (San Francisco, CA), Frank Howard Memorial Hospital (Willits, CA), and St. Rose Hospital (Hayward, CA). The primary investigators will be Dr. Bruce M. McCormack, Dr. William Bowen, and Dr. Brent Keyser respectively. Much like the retrospective analysis, validated outcome questionnaire data will be collected preoperatively and postoperatively of carpal tunnel release surgery performed with the MANOS Carpal Tunnel Release System. A few additional outcome variables will be measured, such as grip strength, pinch strength, hand dexterity, etc. The primary endpoint is to determine the efficacy of the MANOS Carpal Tunnel Release System. All pertinent clinical trial documents have been formulated and submitted to each institution’s respective Institutional Review Board (IRB). IRB approval has been received from all three sites. The clinical study is expected to conclude by mid-2012.

Published Scientific Literature on CTR

  • Abouzahr MK, Patsis MC, Chiu DT. Carpal tunnel release using limited direct vision. Plast Reconstr Surg. 1995;95(3):534-538. link
  • Adams ML, Franklin GM, Barnhart S. Outcome of carpal tunnel surgery in washington state workers' compensation. Am J Ind Med. 1994;25(4):527-536. link
  • Agee JM, McCarroll HR,Jr, Tortosa RD, Berry DA, Szabo RM, Peimer CA. Endoscopic release of the carpal tunnel: A randomized prospective multicenter study. J Hand Surg Am. 1992;17(6):987-995. link
  • Agee JM, Peimer CA, Pyrek JD, Walsh WE. Endoscopic carpal tunnel release: A prospective study of complications and surgical experience. J Hand Surg Am. 1995;20(2):165-71; discussion 172. link
  • al-Qattan MM, Manktelow RT, Bowen CV. Outcome of carpal tunnel release in diabetic patients. J Hand Surg Br. 1994;19(5):626-629. link
  • Appleby MA, Neville-Smith M, Parrott MW. Functional outcomes post carpal tunnel release: A modified replication of a previous study. J Hand Ther. 2009;22(3):240-8; quiz 249. link
  • Boeckstyns ME, Sorensen AI. Does endoscopic carpal tunnel release have a higher rate of complications than open carpal tunnel release? an analysis of published series. J Hand Surg Br. 1999;24(1):9-15. link
  • Brown MG, Keyser B, Rothenberg ES. Endoscopic carpal tunnel release. J Hand Surg Am. 1992;17(6):1009-1011. link
  • Cellocco P, Rossi C, Bizzarri F, Patrizio L, Costanzo G. Mini-open blind procedure versus limited open technique for carpal tunnel release: A 30-month follow-up study. J Hand Surg Am. 2005;30(3):493-499. link
  • Chow JC. The chow technique of endoscopic release of the carpal ligament for carpal tunnel syndrome: Four years of clinical results. Arthroscopy. 1993;9(3):301-314. link
  • Chow JC. Endoscopic release of the carpal ligament for carpal tunnel syndrome: 22-month clinical result. Arthroscopy. 1990;6(4):288-296. link
  • Cresswell TR, Heras-Palou C, Bradley MJ, et al. Long-term outcome after carpal tunnel decompression - a prospective randomised study of the indiana tome and a standard limited palmar incision. J Hand Surg Eur Vol. 2008;33(3):332-336. link
  • Erdmann MW. Endoscopic carpal tunnel decompression. J Hand Surg Br. 1994;19(1):5-13. link
  • Franklin GM, Haug J, Heyer N, Checkoway H, Peck N. Occupational carpal tunnel syndrome in washington state, 1984-1988. Am J Public Health. 1991;81(6):741-746. link
  • Grunert BK, Wertsch JJ, Matloub HS, McCallum-Burke S. Reliability of sensory threshold measurement using a digital vibrogram. J Occup Med. 1990;32(2):100-102. link
  • Hamed AR, Makki D, Chari R, Packer G. Double- versus single-incision technique for open carpal tunnel release. Orthopedics. 2009;32(10):10.3928/01477447-20090818-14. link
  • Hansen TB, Dalsgaard J, Meldgaard A, Larsen K. A prospective study of prognostic factors for duration of sick leave after endoscopic carpal tunnel release. BMC Musculoskelet Disord. 2009;10:144. link
  • Heywood JT, Morley JW. Texture discrimination in carpal tunnel syndrome. Brain. 1992;115 ( Pt 4)(Pt 4):1081-1092. link
  • Jablecki CK, Andary MT, Floeter MK, et al. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome. report of the american association of electrodiagnostic medicine, american academy of neurology, and the american academy of physical medicine and rehabilitation. Neurology. 2002;58(11):1589-1592. link
  • Kaplan SJ, Glickel SZ, Eaton RG. Predictive factors in the non-surgical treatment of carpal tunnel syndrome. J Hand Surg Br. 1990;15(1):106-108. link
  • Kelly CP, Pulisetti D, Jamieson AM. Early experience with endoscopic carpal tunnel release. J Hand Surg Br. 1994;19(1):18-21. link
  • Kerr CD, Gittins ME, Sybert DR. Endoscopic versus open carpal tunnel release: Clinical results. Arthroscopy. 1994;10(3):266-269. link
  • Koris M, Gelberman RH, Duncan K, Boublick M, Smith B. Carpal tunnel syndrome. evaluation of a quantitative provocational diagnostic test. Clin Orthop Relat Res. 1990;(251)(251):157-161. link
  • Lewicky RT. Endoscopic carpal tunnel release: The guide tube technique. Arthroscopy. 1994;10(1):39-49. link
  • Menon J. Endoscopic carpal tunnel release: Preliminary report. Arthroscopy. 1994;10(1):31-38. link
  • Monsivais JJ, Bucher PA, Monsivais DB. Nonsurgically treated carpal tunnel syndrome in the manual worker. Plast Reconstr Surg. 1994;94(5):695-698. link
  • Vasiliadis HS, Xenakis TA, Mitsionis G, Paschos N, Georgoulis A. Endoscopic versus open carpal tunnel release. Arthroscopy. 2010;26(1):26-33. link
  • Zyluk A, Strychar J. A comparison of two limited open techniques for carpal tunnel release. J Hand Surg Br. 2006;31(5):466-472. link

Nerve Stimulation Articles

  • Bashein G, Haschke RH, Ready LB. Electrical nerve location: Numerical and electrophoretic comparison of insulated vs uninsulated needles. Anesth Analg. 1984;63(10):919-924. link
  • Benzon HT, Kim C, Benzon HP, et al. Correlation between evoked motor response of the sciatic nerve and sensory blockade. Anesthesiology. 1997;87(3):547-552. link
  • Chapman GM. Regional nerve block with the aid of a nerve stimulator. Anaesthesia. 1972;27(2):185-193.linkli>
  • Dalrymple P, Chelliah S. Electrical nerve locators. Continuing Education in Anaesthesia, Critical Care & Pain. 2006;6(1):32. link
  • De Andres J, Sala-Blanch X. Peripheral nerve stimulation in the practice of brachial plexus anesthesia: A review. Reg Anesth Pain Med. 2001;26(5):478-483. link
  • Ford DJ, Pither C, Raj PP. Comparison of insulated and uninsulated needles for locating peripheral nerves with a peripheral nerve stimulator. Anesth Analg. 1984;63(10):925-928. link
  • Hadzic A. Peripheral nerve stimulators: Cracking the code--one at a time. Reg Anesth Pain Med. 2004;29(3):185-188. link
  • Hadzic A, Vloka JD, Claudio RE, Hadzic N, Thys DM, Santos AC. Electrical nerve localization: Effects of cutaneous electrode placement and duration of the stimulus on motor response. Anesthesiology. 2004;100(6):1526-1530. link
  • Johnson CR, Barr RC, Klein SM. A computer model of electrical stimulation of peripheral nerves in regional anesthesia. Anesthesiology. 2007;106(2):323-330. link
  • Lanz U. Anatomical variations of the median nerve in the carpal tunnel. J Hand Surg Am. 1977;2(1):44-53. link
  • Lund KM, Rosenblatt MA. The history of peripheral nerve stimulators. American Society of Anesthesiologists Annual Meeting. Chicago 2007. link
  • Raj PP, Rosenblatt R, Montgomery SJ. Use of the nerve stimulator for peripheral blocks. Reg Anesth Pain Med. 1980;5(2):14. link
  • Tulchinsky A, Weller RS, Rosenblum M, Gross JB. Nerve stimulator polarity and brachial plexus block. Anesth Analg. 1993;77(1):100-103. link
  • Vloka JD, Hadzic A. The intensity of the current at which sciatic nerve stimulation is achieved is a more important factor in determining the quality of nerve block than the type of motor response obtained. Anesthesiology. 1998;88(5):1408-1411. link
  • Vuckovic A, Struijk JJ, Rijkhoff NJ. Influence of variable nerve fibre geometry on the excitation and blocking threshold. A simulation study. Med Biol Eng Comput. 2005;43(3):365-374. link