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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02187653
Other study ID # DOC 1002
Secondary ID
Status Recruiting
Phase N/A
First received July 7, 2014
Last updated July 9, 2014
Start date September 2011

Study information

Verified date July 2014
Source DC2 Healthcare
Contact Christina R Cook, PhD
Phone 615-712-9574
Email ccook@dc2healthcare.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States DC2 Healthcare Nashville Tennessee

Sponsors (3)

Lead Sponsor Collaborator
DC2 Healthcare National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation, National Research Independent Operations Management

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary Complications At time of surgery Yes
Primary 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 No
Primary 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 No
Primary Complications 24 hours after surgery Yes
Primary Complications within 6 weeks after surgery but not less than 4 weeks 6 weeks after surgery Yes
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