Neuromonitoring During the Latarjet Procedure
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|ClinicalTrials.gov Identifier: NCT01621126|
Recruitment Status : Completed
First Posted : June 18, 2012
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
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 or disease||Intervention/treatment||Phase|
|Shoulder Instability Iatrogenic Nerve Injury||Device: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neuromonitoring During the Latarjet Procedure|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||October 2014|
|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.
- 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.
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
|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|