Neuromonitoring During the Latarjet Procedure
Completed · Not applicable
Conditions studied: Shoulder Instability, Iatrogenic Nerve Injury
In brief
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.
Key facts
- Study ID
- NCT01621126
- Run by
- Massachusetts General Hospital
- People needed
- 40
- Starts
- 2011-06-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2016-05-23
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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.
Where it is running
- Massachussetts General Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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