Neuromonitoring During the Latarjet Procedure

NCT01621126 | Completed Results

• 1 other identifier: 2011P000188
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Shoulder Instability; Iatrogenic Nerve Injury

Keywords

Shoulder instability; Latarjet procedure; Nerve injury

Outcome Measures

Primary Outcomes (1)

• Neurologic Complication Rate After Latarjet Procedure

  Nerve palsy of any nerve(s) in the operative upper extremity.

  up to 24 weeks after the procedure

Study Arms (1)

Intra-op neuromonitoring

EXPERIMENTAL

Device: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)

Interventions

Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor) DEVICE

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.

Intra-op neuromonitoring

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Our patients who have received prior approval from their insurance carrier to cover neuromonitoring during the surgical procedure will be enrolled.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Massachussetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Shah AA, Butler RB, Romanowski J, Goel D, Karadagli D, Warner JJ. Short-term complications of the Latarjet procedure. J Bone Joint Surg Am. 2012 Mar 21;94(6):495-501. doi: 10.2106/JBJS.J.01830.

  PMID: 22318222 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

Results Point of Contact

• Title: Dr. Jon J.P. Warner, Chief of Shoulder Service MGH, Harvard Professor of Orthopaedics.
• Organization: Massachusetts General Hospital

jwarner@mgh.harvard.edu

617-724-3140

Study Officials

• Jon JP Warner, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, MGH Shoulder Service

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2014
• Last Updated: May 23, 2016
• Results First Posted: May 23, 2016

Record last verified: 2016-04

Locations

US (2)