An interventional study of Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor) in Shoulder Instability and Iatrogenic Nerve Injury, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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.
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Nerve palsy of any nerve(s) in the operative upper extremity.
Time frame: up to 24 weeks after the procedure
| Milestone | Intra-op Neuromonitoring |
|---|---|
| Started | 40 |
| Completed | 34 |
| Not completed | 6 |
| Withdrew: Physician decision | 6 |
Nerve palsy of any nerve(s) in the operative upper extremity.
| participants | Intra-op Neuromonitoring |
|---|---|
| Neurologic Complication Rate After Latarjet Procedure | 7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intra-op Neuromonitoring | — | 0/40 (0%) | 0/40 (0%) |
40 subjects were enrolled; however, there were some subjects that were excluded for reasons that are explained in the published paper that resulted from this study. The total number of subjects excluded was 6, leaving 34 participants to be analyzed.
| Age, Categorical(Participants) | Intra-op Neuromonitoring |
|---|---|
| <=18 years | 3 |
| Between 18 and 65 years | 30 |
| >=65 years | 1 |
| Age, Continuous(years) | Intra-op Neuromonitoring |
|---|---|
| Mean | 28.4 (15 to 66) |
| Sex: Female, Male(Participants) | Intra-op Neuromonitoring |
|---|---|
| Female | 6 |
| Male | 28 |
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