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Neuromonitoring During the Latarjet Procedure

This study has suspended participant recruitment.
(Suspended pending registration on clinicaltrials.gov.)
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jon JP Warner, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01621126
First received: June 7, 2012
Last updated: June 15, 2012
Last verified: June 2012

June 7, 2012
June 15, 2012
June 2011
June 2013   (final data collection date for primary outcome measure)
Neurologic complication rate after Latarjet procedure [ Designated as safety issue: Yes ]
Nerve palsy of any nerve(s) in the operative upper extremity.
Same as current
Complete list of historical versions of study NCT01621126 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neuromonitoring During the Latarjet Procedure
Neuromonitoring During the Latarjet Procedure

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Shoulder Instability
  • Iatrogenic Nerve Injury
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.
Experimental: Intra-op neuromonitoring
Intervention: Device: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All adult 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01621126
2011P000188
No
Jon JP Warner, Massachusetts General Hospital
Massachusetts General Hospital
Brigham and Women's Hospital
Principal Investigator: Jon JP Warner, MD Massachusetts General Hospital
Massachusetts General Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP