Neuromonitoring During the Latarjet Procedure

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jon JP Warner, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01621126
First received: June 7, 2012
Last updated: April 19, 2016
Last verified: April 2016
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Shoulder Instability
Iatrogenic Nerve Injury
Intervention: Device: Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Intra-op Neuromonitoring  
STARTED     40  
COMPLETED     34  
NOT COMPLETED     6  
Physician Decision                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.

Baseline Measures
    Intra-op Neuromonitoring  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     30  
>=65 years     1  
Age  
[units: years]
Mean (Full Range)
  28.4  
  (15 to 66)  
Gender  
[units: participants]
 
Female     6  
Male     28  



  Outcome Measures

1.  Primary:   Neurologic Complication Rate After Latarjet Procedure   [ Time Frame: up to 24 weeks after the procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jon J.P. Warner, Chief of Shoulder Service MGH, Harvard Professor of Orthopaedics.
Organization: Massachusetts General Hospital
phone: 617-724-3140
e-mail: jwarner@mgh.harvard.edu


Publications:

Responsible Party: Jon JP Warner, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01621126     History of Changes
Other Study ID Numbers: 2011P000188
Study First Received: June 7, 2012
Results First Received: April 7, 2015
Last Updated: April 19, 2016
Health Authority: United States: Institutional Review Board