NOC2 Spine Registry
National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products
1 other identifier
observational
10,000
1 country
1
Brief Summary
The primary objective of the Spine Registry is to enhance the understanding of spinal disease and treatment of spinal disease with the goal of guiding treatment options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
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
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 9, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedJuly 11, 2014
July 1, 2014
5 years
July 9, 2014
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
Pain intensity scale taken at baseline and 4 weeks after surgery
baseline and 4 weeks after surgery
Change in Visual Analogue Scale (VAS) from baseline at 3 months
Pain intensity scale taken at baseline and 3 months after surgery
baseline and 3 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 6 months
Pain intensity scale taken at baseline and 6 months after surgery
baseline and 6 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 12 months
Pain intensity scale taken at baseline and 12 months after surgery
baseline and 12 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 24 months
Pain intensity scale taken at baseline and 24 months after surgery
baseline and 24 months after surgery
Secondary Outcomes (24)
Change from baseline in Oswestry Disability index at 4 weeks
baseline and 4 weeks after surgery
Fusion at 6 months
6 months post-op
Length of hospital stay
one to three days following surgery
Revision surgery within 30 days
30 days after surgery
Return to work
4 weeks after surgery
- +19 more secondary outcomes
Study Arms (2)
Lumbar
Patients undergoing lumbar spinal surgery
Cervical
Patients undergoing cervical spine surgery
Eligibility Criteria
Approximately 10,000 patients undergoing lumbar or cervical surgery will be screened to decide whether they meet the inclusion and exclusion criteria of the study/patient registry. Patients who meet the study criteria will be informed by the investigator and should read the 'patient information' document. Patients must give their written informed consent to be enrolled into this study.
You may qualify if:
- Patients undergoing lumbar or cervical surgery
- Understand and sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DC2 Healthcare
Nashville, Tennessee, 37211, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2014
First Posted
July 11, 2014
Study Start
December 1, 2011
Primary Completion
December 1, 2016
Last Updated
July 11, 2014
Record last verified: 2014-07