NCT02187653

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

5.3 years

First QC Date

July 7, 2014

Last Update Submit

July 9, 2014

Conditions

Intraoperative MonitoringSpinal Diseases

Keywords

IOMIONMIntraoperative MonitoringIntraoperative NeuromonitoringSpineLumbarCervical

Outcome Measures

Primary Outcomes (7)

  • Change from baseline in Neurological Assessment at 24 hours

    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

    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

    At time of surgery

  • Change from baseline in Neurological Assessment at 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

    Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks

    baseline and 6 weeks

  • Complications

    24 hours after surgery

  • Complications

    within 6 weeks after surgery but not less than 4 weeks

    6 weeks after surgery

Study Arms (2)

Lumbar

Patients undergoing lumbar surgery

Cervical

Patients undergoing cervical surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DC2 Healthcare

Nashville, Tennessee, 37203, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Christina R Cook, PhD

CONTACT

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

CONTACT

615-712-9574rtyo@dc2healthcare.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 11, 2014

Study Start

September 1, 2011

Primary Completion

December 1, 2016

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

US(1)