Clinical trial NCT02187666: NOC2 Spine Registry
Official title: National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Disease
Keywords: Cervical
Lumbar
Spine
Spinal Disease
Lead sponsor: DC2 Healthcare
Sponsor class: INDUSTRY
Collaborators: name: National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2)
name: National Research Independent Operations Management
First posted: 2014-07-11
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: This study will enhance the understanding of the variability, progression and treatment of spinal disease with the ultimate goal of better guiding and assessing therapeutic intervention. Researchers will collect complications and safety following cervical and lumbar surgeries to determine best options for patients. Prospective reports will be collected on patients undergoing lumbar or cervical spinal surgery. Patients will be enrolled in registry after signing informed consent. Data will be collected at various time points. The registry will serve as a database of cervical and lumbar surgeries in which retrospective analysis and exploratory analysis of specific research questions can be answered.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lumbar or cervical surgery
* Understand and sign informed consent

Exclusion Criteria:

* There are no specific exclusion criteria

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
timeFrame: baseline and 4 weeks after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 3 months
timeFrame: baseline and 3 months after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 6 months
timeFrame: baseline and 6 months after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 12 months
timeFrame: baseline and 12 months after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 24 months
timeFrame: baseline and 24 months after surgery
Secondary outcomes:
measure: Change from baseline in Oswestry Disability index at 4 weeks
timeFrame: baseline and 4 weeks after surgery
measure: Fusion at 6 months
timeFrame: 6 months post-op
measure: Length of hospital stay
timeFrame: one to three days following surgery
measure: Revision surgery within 30 days
timeFrame: 30 days after surgery
measure: Return to work
timeFrame: 4 weeks after surgery
measure: Return to normal/usual activity
timeFrame: 4 weeks after surgery
measure: Complications
timeFrame: 24 hours after surgery
measure: Change from baseline in Oswestry Disability index at 3 months
timeFrame: baseline and 3 months after surgery
measure: Change from baseline in Oswestry Disability index at 6 months
timeFrame: baseline and 6 months after surgery
measure: Change from baseline in Oswestry Disability index at 12 months
timeFrame: baseline and 12 months after surgery
measure: Change from baseline in Oswestry Disability index at 24 months
timeFrame: baseline and 24 months after surgery
measure: Return to work
timeFrame: 3 months after surgery
measure: Return to work
timeFrame: 6 months after surgery
measure: Return to work
timeFrame: 12 months after surgery
measure: Return to work
timeFrame: 24 months after surgery
measure: Return to normal/usual activity
timeFrame: 3 months after surgery
measure: Return to normal/usual activity
timeFrame: 6 months after surgery
measure: Return to normal/usual activity
timeFrame: 12 months after surgery
measure: Return to normal/usual activity
timeFrame: 24 months after surgery
measure: Complications
timeFrame: 4 weeks after surgery
measure: Complications
timeFrame: 3 months after surgery
measure: Complications
timeFrame: 6 months after surgery
measure: Complications
timeFrame: 12 months after surgery
measure: Complications
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: Nashville
country: United States
facility: DC2 Healthcare
state: Tennessee
Study officials:
References: