Intraoperative Monitoring (IOM) Patient Registry (IOM)

July 9, 2014 updated by: DC2 Healthcare

Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM

The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.

Study Overview

Status

Unknown

Conditions

Detailed Description

Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in registry after signing informed consent. Data will be collected prior to surgery, during surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve as a database for surgeries using IOM.

Specific outcome measures will be: neurological assessment, length of hospital stay, pain intensity, and complications.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cervical or lumbar surgery in which intraoperative monitoring has been utilized.

Description

Inclusion Criteria:

  • Patients undergoing lumbar or cervical surgery
  • Utilization of IOM
  • Understand and sign informed consent

Exclusion Criteria:

  • There are no specific exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Lumbar
Patients undergoing lumbar surgery
Cervical
Patients undergoing cervical surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Neurological Assessment at 24 hours
Time Frame: baseline and 24 hours from time of surgery
Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery
baseline and 24 hours from time of surgery
Change in Pain Intensity from Baseline at 24 hours
Time Frame: baseline and 24 hours from time of surgery
Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery
baseline and 24 hours from time of surgery
Complications
Time Frame: At time of surgery
At time of surgery
Change from baseline in Neurological Assessment at 6 weeks
Time Frame: baseline and 6 weeks
Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks
baseline and 6 weeks
Change in Pain Intensity from Baseline at 6 weeks
Time Frame: baseline and 6 weeks
Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks
baseline and 6 weeks
Complications
Time Frame: 24 hours after surgery
24 hours after surgery
Complications
Time Frame: 6 weeks after surgery
within 6 weeks after surgery but not less than 4 weeks
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DC2 Healthcare

Collaborators

National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation
National Research Independent Operations Management

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC 1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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