Intraoperative Monitoring (IOM) Patient Registry

NCT ID: NCT02187653

Last Updated: 2014-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intraoperative Monitoring Spinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lumbar

Patients undergoing lumbar surgery

No interventions assigned to this group

Cervical

Patients undergoing cervical surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing lumbar or cervical surgery
* Utilization of IOM
* Understand and sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation

UNKNOWN

Sponsor Role collaborator

National Research Independent Operations Management

OTHER

Sponsor Role collaborator

DC2 Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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DC2 Healthcare

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christina R Cook, PhD

Role: CONTACT

615-712-9574

Risa Tyo, PharmD

Role: CONTACT

615-712-9574

Facility Contacts

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Christina R Cook, PhD

Role: primary

615-712-9574

Risa Tyo, PharmD

Role: backup

615-712-9574

Related Links

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Other Identifiers

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DOC 1002

Identifier Type: -

Identifier Source: org_study_id

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