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.
|Shoulder Instability Iatrogenic Nerve Injury||Device: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Neuromonitoring During the Latarjet Procedure|
- 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.
|Study Start Date:||June 2011|
|Study Completion Date:||October 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621126
|United States, Massachusetts|
|Massachussetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jon JP Warner, MD||Massachusetts General Hospital|