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Neuromonitoring During the Latarjet Procedure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621126
First Posted: June 18, 2012
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jon JP Warner, Massachusetts General Hospital
  Purpose

In a study performed by the Harvard Shoulder Service, it has been documented that there is a significant incidence of neurologic complications of the Latarjet procedure for shoulder instability. 5 out of 52 patients had neurologic complaints post-operatively. 3 of these nerve palsies were transient, however 2 had not yet recovered fully at time of latest follow-up and returned to the operating room for exploration and neurolysis of the axillary nerve and brachial plexus.

By using intra-operative neuromonitoring to determine exactly when there is a potential nerve injury during the procedure, the investigators will be able to modify what the investigators do at that step of the procedure, in order to decrease or possibly even eliminate the risk of neurologic injury.


Condition Intervention
Shoulder Instability Iatrogenic Nerve Injury Device: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Neuromonitoring During the Latarjet Procedure

Further study details as provided by Jon JP Warner, Massachusetts General Hospital:

Primary Outcome Measures:
  • Neurologic Complication Rate After Latarjet Procedure [ Time Frame: up to 24 weeks after the procedure ]
    Nerve palsy of any nerve(s) in the operative upper extremity.


Enrollment: 40
Study Start Date: June 2011
Study Completion Date: October 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-op neuromonitoring Device: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)
Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.

Detailed Description:
The investigators propose to study the intra-operative events which put nerves at risk during the Latarjet procedure. By using neuromonitoring to determine exactly when there is a potential nerve injury during the procedure, the investigators will be able to modify what the investigators do at that step of the procedure, in order to decrease or possibly even eliminate the risk of neurologic injury. Modifications to our surgical technique in response to events observed on neuromonitoring would include repositioning the operative shoulder and upper extremity, and repositioning or removing retractors. The investigators believe this would lead to a significant decrease in the incidence of neurologic complications post-operatively. Since this operation is usually performed on young, active patients, the benefits of reducing or eliminating these complications would have a far-reaching impact both for the individual and for society. Above all, the investigators feel that this is an important patient safety initiative.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients of the two senior surgeons who will undergo the Latarjet procedure for shoulder instability will be considered for inclusion in the study.
  • Our patients who have received prior approval from their insurance carrier to cover neuromonitoring during the surgical procedure will be enrolled.

Exclusion Criteria:

  • Relative contraindications to transcranial electrical stimulation include: history of seizures, significant brain trauma, cerebral edema with mass effect, recent CVA, intracerebral devices (e.g., shunts, aneurysmal clips), skull defect and cardiac pacemaker. Patients with there conditions will be included in the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621126


Locations
United States, Massachusetts
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Investigators
Principal Investigator: Jon JP Warner, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Jon JP Warner, Chief, MGH Shoulder Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01621126     History of Changes
Other Study ID Numbers: 2011P000188
First Submitted: June 7, 2012
First Posted: June 18, 2012
Results First Submitted: April 7, 2015
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016
Last Verified: April 2016

Keywords provided by Jon JP Warner, Massachusetts General Hospital:
Shoulder instability
Latarjet procedure
Nerve injury