Clinical trial NCT01621126: Neuromonitoring During the Latarjet Procedure
Official title: Neuromonitoring During the Latarjet Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Instability
Iatrogenic Nerve Injury
Keywords: Shoulder instability
Latarjet procedure
Nerve injury
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2012-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Neurologic Complication Rate After Latarjet Procedure
timeFrame: up to 24 weeks after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachussetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jon JP Warner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.