Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery

December 29, 2020 updated by: Jason Chui, Lawson Health Research Institute

Detection and Prevention of Perioperative Nerve Injury Using Automated Somatosensory Evoked Potential Monitoring in Shoulder Arthroplasty Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Perioperative PNI is a well-recognized but seriously under-investigated complication of general anesthesia. Arguably, such nerve injury may be viewed as being as devastating as spinal cord and cerebral injury, as the resultant functional disabilities may be very comparable.(1) Many such nerve injured patients require prolonged recovery and rehabilitation, while some result in long-term disability and/or litigation due to motor deficits and chronic pain.(2-5) In ASA Closed Claims Analysis PNI was the second most common cause of claims other than death.(6, 7) However, little progress has been made in the past three decades in developing a reliable intraoperative monitoring technique for early detection and prevention. SSEP monitoring is a potential option for preventing PNI. Abnormal SSEP is widely used as a surrogate outcome for PNI in research studies (8-11). Additionally, previous studies (12-17) investigating the use of SSEP for spinal cord or cerebral injury during neurosurgical procedures have incidentally found high incidences of abnormal SSEP (4-7%) due to mal-positioning that was corrected with repositioning; this suggested SSEP could be used to detect intraoperative PNI and that prompt intervention can reverse PNI. However, there have been no further prospective studies to evaluate the diagnostic value of SSEP, or its outcome benefit. This is largely because conventional SSEP is a bulky, expensive and labor-intensive monitoring modality, requiring a technologist for operation and interpretation.(18) Because of these budgetary and logistical limitations, as well as the relative lack of clinical evidence, SSEP is not performed routinely in most surgical centres solely for the purpose of PNI detection. The recent introduction of the Evoked Potential Assessment Device (EPAD®, SafeOp Surgical, Hunt Valley, MD) may be able to overcome these practical barriers. It is a novel, simplified, automated SSEP monitoring device (FDA approved). The key features of EPAD® are its compactness, ease of connectivity via Bluetooth, and its use of surface adhesive electrodes that remove the potential for needle-stick injuries. This device also incorporates an automated progressive signal optimization algorithm, several newly developed artifact rejection and electrocautery suppression technologies as well as an auto-interpretation diagnostic system. It eliminates the need for a designated technician and permits simplified and direct interpretation of the SSEP data for clinicians in the operating room. This device also enables display and storage of raw SSEP data permitting post hoc area-under-curve analysis. (Fig. 3) We have previously evaluated the clinical utility of this automated SSEP device in 33 cardiac surgical patients (19). This pilot study found that automated SSEP monitoring can be performed readily in a busy cardiac operating room. The raw signal quality is reliable and comparable to the conventional SSEP machine. These results indicate that this device is able to eliminate the practical challenges of performing SSEP monitoring and confirmed its feasibility for routine use.(REB# 104826) Surgical-related nerve injury during TSA is one of the highest risk subspecialties leading to postoperative upper limb peripheral neuropathy with reported incidences of 1-4% (20-22). A previous cohort study10, using motor evoked potential and EMG to evaluate the nerve injury during TSA, reported an exceedingly high incidence of intraoperative alerts (56.7% of patients). Importantly, 76.7% (23 of 30) of nerve alerts were reversed with repositioning of the patients' arm and removal of the retractor. Another cohort study11 in shoulder rotator cuff repair reported an even higher incidence of nerve alert (76.5%). Both studies were received Neer research awards from the Orthopedic Society, however neither study has informed the outcome benefit nor has assessed the relationship between cumulative injury, baseline nerve reserve and postoperative neuropathy. Accordingly, we propose to perform single blinded, superiority, parallel design, prospective randomized controlled study to assess the efficacy of the automated SSEP device in preventing PNI during TSA and explore the dose-response relationship of PNI.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automated SSEP Monitored Group
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@)
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.
No Intervention: Standard Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative duration of abnormal SSEP changes
Time Frame: duration of surgery
The cumulative duration (min) of abnormal SSEP changes in the operative arm.
duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New-onset of peripheral neuropathy
Time Frame: 2 weeks, 6 weeks and 3 months
New-onset peripheral neuropathy of the operative arm at postoperative 6 weeks. A thorough neurologic examination will be performed by an independent assessor before (after brachial plexus catheter inserted), and after the surgery (6 weeks). Any new neurological deficit at postoperative 6 weeks that identified by the independent outcomes assessor will be defined as a positive case.
2 weeks, 6 weeks and 3 months
American shoulder and elbow surgeons standardized shoulder assessment form
Time Frame: 2 weeks, 6 weeks and 3 months
ASES score is a 100 point scale that consists of two dimensions; pain and daily activity. The pain scale is worth 50 points and the daily activity is worth 50 points. 100 points describes being pain- free and able to complete daily activity with no issues while a score of 0 describes extreme pain and unable to complete daily activities.
2 weeks, 6 weeks and 3 months
Quality of life measure
Time Frame: 2 weeks, 6 weeks and 3 months
The EQ-5D-5L score consists of two components: a descriptive component to assess five dimensions of quality of life and an EQ visual analogue scale (VAS). The EQ-5D health state index is a single summary index, ranging from 0 to 1 (where 0 denotes death and 1 denotes full health/function), that is weighted to the country/region to describe the five dimensions of EQ-5D.
2 weeks, 6 weeks and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108951

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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