Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery

NCT03624426 | Completed

• 1 other identifier: 108951
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 5% of total shoulder arthroplasty patients experience transient or permanent nerve injury during surgery. In this study, we will monitor the nerve transmission of the patients' arm to detect whether the nerve is functioning normally. This techniques is called somatosensory evoked potential (SSEP) monitoring. In this study, we will assess whether SSEP monitoring could detect nerve abnormalities, alerts the surgical team enabling optimize their surgical intervention and prevent surgical related nerve injury.

Conditions

Neuropathy; Nerve Injury

Keywords

nerve monitoring; automated somatosensory evoked potential; nerve injury

Outcome Measures

Primary Outcomes (1)

• Cumulative duration of abnormal SSEP changes

  The cumulative duration (min) of abnormal SSEP changes in the operative arm.

  duration of surgery

Secondary Outcomes (3)

• New-onset of peripheral neuropathy

  2 weeks, 6 weeks and 3 months

• American shoulder and elbow surgeons standardized shoulder assessment form

  2 weeks, 6 weeks and 3 months

• Quality of life measure

  2 weeks, 6 weeks and 3 months

Study Arms (2)

Automated SSEP Monitored Group

EXPERIMENTAL

SSEP monitored group: When a nerve alert is signaled by the automated SSEP device, the surgeon will be informed with the aim to reverse the signal changes. The possible surgical interventions include repositioning the operative arm into a more neutral position, avoidance of excessive traction, removal of retractors, and using a smaller implant to avoid over-correction/traction. The actual intervention will depend on the possible mechanism of nerve injury and treated accordingly.

Device: Automated Somatosensory Evoked Potential device (EPAD@)

Standard Group

NO INTERVENTION

The automated SSEP device will be connected and will be blinded to the surgeon. The screens of the automated SSEP device will be covered by an opaque plastic bag and the alarms will be turned off. No intervention is planned for this group.

Interventions

Automated Somatosensory Evoked Potential device (EPAD@) DEVICE

After commencement of general anesthesia and during patient positioning, stimulating sensors will be applied to patient wrists and a recording sensor is applied at base of neck posteriorly (at C5 level), forehead and the bilateral wrists. The monitoring will be continued throughout the surgery.

Automated SSEP Monitored Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult elective patients undergoing total shoulder arthroplasty surgery using general anesthesia

You may not qualify if:

• Patients unable to perform complete neurological examination
• Patients who refuse to participate
• Unable to obtain informed consent.
• Patients who are contraindicated for (or unable to perform) SSEP monitoring
• Patients who have known pre-existing peripheral neuropathy or brachial plexus injury
• Patients who are contraindicated to brachial plexus block

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (22)

• Wojtkiewicz DM, Saunders J, Domeshek L, Novak CB, Kaskutas V, Mackinnon SE. Social impact of peripheral nerve injuries. Hand (N Y). 2015 Jun;10(2):161-7. doi: 10.1007/s11552-014-9692-0.

  PMID: 26034424 BACKGROUND

• Grocott HP, Clark JA, Homi HM, Sharma A. "Other" neurologic complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):213-26. doi: 10.1177/108925320400800304.

  PMID: 15375481 BACKGROUND

• Sharma AD, Parmley CL, Sreeram G, Grocott HP. Peripheral nerve injuries during cardiac surgery: risk factors, diagnosis, prognosis, and prevention. Anesth Analg. 2000 Dec;91(6):1358-69. doi: 10.1097/00000539-200012000-00010. No abstract available.

  PMID: 11093980 BACKGROUND

• Tajiri O, Tateda T, Sugihara H, Yokoyama H, Nishikido O, Mukumoto C. [Brachial plexus neuropathy following open-heart surgery]. Masui. 2004 Apr;53(4):407-10. Japanese.

  PMID: 15160668 BACKGROUND

• Fitzgerald M, McKelvey R. Nerve injury and neuropathic pain - A question of age. Exp Neurol. 2016 Jan;275 Pt 2:296-302. doi: 10.1016/j.expneurol.2015.07.013. Epub 2015 Jul 26.

  PMID: 26220898 BACKGROUND

• Kroll DA, Caplan RA, Posner K, Ward RJ, Cheney FW. Nerve injury associated with anesthesia. Anesthesiology. 1990 Aug;73(2):202-7. doi: 10.1097/00000542-199008000-00002.

  PMID: 2382845 BACKGROUND

• Cheney FW, Domino KB, Caplan RA, Posner KL. Nerve injury associated with anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1062-9. doi: 10.1097/00000542-199904000-00020.

  PMID: 10201678 BACKGROUND

• Jellish WS, Blakeman B, Warf P, Slogoff S. Somatosensory evoked potential monitoring used to compare the effect of three asymmetric sternal retractors on brachial plexus function. Anesth Analg. 1999 Feb;88(2):292-7. doi: 10.1097/00000539-199902000-00012.

  PMID: 9972743 BACKGROUND

• Wilent B, Oppenheimer S. Utlility of nerve monitoring during shoulder arthroplasty. Journal of Clinical Neurophysiology 2012; 29 (6): 536

  BACKGROUND

• Nagda SH, Rogers KJ, Sestokas AK, Getz CL, Ramsey ML, Glaser DL, Williams GR Jr. Neer Award 2005: Peripheral nerve function during shoulder arthroplasty using intraoperative nerve monitoring. J Shoulder Elbow Surg. 2007 May-Jun;16(3 Suppl):S2-8. doi: 10.1016/j.jse.2006.01.016. Epub 2006 Jul 26.

  PMID: 17493556 BACKGROUND

• Delaney RA, Freehill MT, Janfaza DR, Vlassakov KV, Higgins LD, Warner JJ. 2014 Neer Award Paper: neuromonitoring the Latarjet procedure. J Shoulder Elbow Surg. 2014 Oct;23(10):1473-80. doi: 10.1016/j.jse.2014.04.003. Epub 2014 Jun 18.

  PMID: 24950948 BACKGROUND

• Larson SJ, Gandhoke GS, Kaur J, et al. Incidence of position related neuropraxia in 4489 consecutive patients undergoing spine surgery. Role of SSEP monitoring? Journal of Neurosurgery 2016; 124 (4): A1182

  BACKGROUND

• Ying T, Wang X, Sun H, Tang Y, Yuan Y, Li S. Clinical Usefulness of Somatosensory Evoked Potentials for Detection of Peripheral Nerve and Brachial Plexus Injury Secondary to Malpositioning in Microvascular Decompression. J Clin Neurophysiol. 2015 Dec;32(6):512-5. doi: 10.1097/WNP.0000000000000212.

  PMID: 26629760 BACKGROUND

• Araus-Galdos E, Delgado P, Villalain C, Martin-Velasco V, Castilla JM, Salazar A. Prevention of brachial plexus injury due to positioning of patient in spinal surgery. Value of multimodal intraoperative neuromonitoring (IONM). Clinical Neurophysiology 2011; 122: S113

  BACKGROUND

• Chung I, Glow JA, Dimopoulos V, Walid MS, Smisson HF, Johnston KW, Robinson JS, Grigorian AA. Upper-limb somatosensory evoked potential monitoring in lumbosacral spine surgery: a prognostic marker for position-related ulnar nerve injury. Spine J. 2009 Apr;9(4):287-95. doi: 10.1016/j.spinee.2008.05.004. Epub 2008 Aug 5.

  PMID: 18684675 BACKGROUND

• Labrom RD, Hoskins M, Reilly CW, Tredwell SJ, Wong PK. Clinical usefulness of somatosensory evoked potentials for detection of brachial plexopathy secondary to malpositioning in scoliosis surgery. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2089-93. doi: 10.1097/01.brs.0000179305.89193.46.

  PMID: 16166901 BACKGROUND

• Schwartz DM, Drummond DS, Hahn M, Ecker ML, Dormans JP. Prevention of positional brachial plexopathy during surgical correction of scoliosis. J Spinal Disord. 2000 Apr;13(2):178-82. doi: 10.1097/00002517-200004000-00015.

  PMID: 10780696 BACKGROUND

• Tamkus A, Rice K. Risk of needle-stick injuries associated with the use of subdermal needle electrodes during intraoperative neurophysiologic monitoring. J Neurosurg Anesthesiol. 2014 Jan;26(1):65-8. doi: 10.1097/ANA.0b013e31829b677c.

  PMID: 23774115 BACKGROUND

• Chui J, Murkin JM, Turkstra T, McKenzie N, Guo L, Quantz M. A Novel Automated Somatosensory Evoked Potential (SSEP) Monitoring Device for Detection of Intraoperative Peripheral Nerve Injury in Cardiac Surgery: A Clinical Feasibility Study. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1174-1182. doi: 10.1053/j.jvca.2016.11.024. Epub 2016 Nov 17.

  PMID: 28159523 BACKGROUND

• Ladermann A, Lubbeke A, Melis B, Stern R, Christofilopoulos P, Bacle G, Walch G. Prevalence of neurologic lesions after total shoulder arthroplasty. J Bone Joint Surg Am. 2011 Jul 20;93(14):1288-93. doi: 10.2106/JBJS.J.00369.

  PMID: 21792494 BACKGROUND

• Carofino BC, Brogan DM, Kircher MF, Elhassan BT, Spinner RJ, Bishop AT, Shin AY. Iatrogenic nerve injuries during shoulder surgery. J Bone Joint Surg Am. 2013 Sep 18;95(18):1667-74. doi: 10.2106/JBJS.L.00238.

  PMID: 24048554 BACKGROUND

• Ho E, Cofield RH, Balm MR, Hattrup SJ, Rowland CM. Neurologic complications of surgery for anterior shoulder instability. J Shoulder Elbow Surg. 1999 May-Jun;8(3):266-70. doi: 10.1016/s1058-2746(99)90140-4.

  PMID: 10389084 BACKGROUND

Study Officials

• Jason Chui, MBChB

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the outcome assessor will be blinded. The physicians and operating room nurses, anesthesiologists could not be blinded due to the nature of the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 parallel, superiority study

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: September 10, 2018
• Primary Completion: November 30, 2019
• Study Completion: March 31, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

CA (1)