N/A
N=40
Neuromonitoring During the Latarjet Procedure
Shoulder Instability · Iatrogenic Nerve Injury
Bottom Line
View on ClinicalTrials.gov: NCT01621126 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Neurologic Complication Rate After Latarjet Procedure — 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor) (Device)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurologic Complication Rate After Latarjet Procedure |
7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01621126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.