Intraoperative MonitoringIOMNCT02187653
Intraoperative Monitoring (IOM) Patient Registry
An observational study of Intraoperative Monitoring and Spinal Diseases, run by DC2 Healthcare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Monitoring, Spinal Diseases
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2016
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cervical or lumbar surgery in which intraoperative monitoring has been utilized.
Who may be able to join
- Patients undergoing lumbar or cervical surgery
- Utilization of IOM
- Understand and sign informed consent
Who cannot join
- There are no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DC2 Healthcare
Nashville, Tennessee, 37203
Christina R Cook, PhD, 615-712-9574, ccook@dc2healthcare.com
Risa Tyo, PharmD, 615-712-9574, rtyo@dc2healthcare.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraoperative Monitoring, Spinal Diseases
- Keywords
- IOM, IONM, Intraoperative Monitoring, Intraoperative Neuromonitoring, Spine, Lumbar, Cervical
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar | Patients undergoing lumbar surgery | |
| Cervical | Patients undergoing cervical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline and 24 hours from time of surgery
Complications
Measured: 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
Measured: 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
Measured: baseline and 6 weeks
Complications
Measured: 24 hours after surgery
Complications
within 6 weeks after surgery but not less than 4 weeks
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startSep 2011
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- DC2 Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation, National Research Independent Operations Management
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187653
- Sponsor's protocol ID
- DOC 1002
- Acronym
- IOM
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM
- ClinicalTrials.gov ID
- NCT02187653
- Acronym / sponsor ID
- IOM / DOC 1002
- Conditions
- Intraoperative Monitoring, Spinal Diseases
- Keywords
- IOM, IONM, Intraoperative Monitoring, Intraoperative Neuromonitoring, Spine, Lumbar, Cervical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- DC2 HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation, National Research Independent Operations Management
- Study start
- Sep 2011
- Primary completion
- Dec 2016 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar | – | –Patients undergoing lumbar surgery |
| Cervical | – | –Patients undergoing cervical surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cervical or lumbar surgery in which intraoperative monitoring has been utilized.
Key inclusion criteria (3 listed)
- Patients undergoing lumbar or cervical surgery
- Utilization of IOM
- Understand and sign informed consent
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Complications
Time frame: 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
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
Complications
Time frame: 24 hours after surgery
Complications
Time frame: 6 weeks after surgery
within 6 weeks after surgery but not less than 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- DC2 HealthcareLink provided by the sponsor.
- NRIOMLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Monitoring and Spinal Diseases, run by DC2 Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina R Cook, PhD (615-712-9574, ccook@dc2healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Neurological Assessment at 24 hours (time frame: baseline and 24 hours from time of surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.