Trial Outcomes & Findings for Neuromonitoring During the Latarjet Procedure (NCT NCT01621126)

Results Overview

Nerve palsy of any nerve(s) in the operative upper extremity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

up to 24 weeks after the procedure

Results posted on

2016-05-23

Participant milestones
Measure	Intra-op Neuromonitoring 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.
Overall Study STARTED	40
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Intra-op Neuromonitoring 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.
Overall Study Physician Decision	6

Neuromonitoring During the Latarjet Procedure

Baseline characteristics by cohort
Measure	Intra-op Neuromonitoring n=34 Participants 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.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	28.4 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants

Timeframe: up to 24 weeks after the procedure

Nerve palsy of any nerve(s) in the operative upper extremity.

Outcome measures
Measure	Intra-op Neuromonitoring n=34 Participants 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	7 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Massachusetts General Hospital

Phone: 617-724-3140