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OpenTrials
Completed

NCT Number: NCT01621126

Neuromonitoring During the Latarjet Procedure

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 18, 2012
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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