NOC2 Spine Registry

Spinal Disease Clinical Trial

Official title:

National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187666
• Other study ID #: NOC 1001
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2014
• Last updated: July 9, 2014
• Start date: December 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 the Spine Registry is to enhance the understanding of spinal disease and treatment of spinal disease with the goal of guiding treatment options.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing lumbar or cervical surgery

• 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

• Spinal Disease
• Spinal Diseases

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), National Research Independent Operations Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change from baseline in Oswestry Disability index at 4 weeks	Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery.	baseline and 4 weeks after surgery	No
Secondary	Fusion at 6 months		6 months post-op	No
Secondary	Length of hospital stay	Date of discharge will be recorded, an average of one to three days	one to three days following surgery	No
Secondary	Revision surgery within 30 days		30 days after surgery	No
Secondary	Return to work	Time off of work and whether patient returned restricted or unrestricted	4 weeks after surgery	No
Secondary	Return to normal/usual activity	Time between surgery and resuming normal activity for patient	4 weeks after surgery	No
Secondary	Complications		24 hours after surgery	Yes
Secondary	Change from baseline in Oswestry Disability index at 3 months	Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery.	baseline and 3 months after surgery	No
Secondary	Change from baseline in Oswestry Disability index at 6 months	Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery.	baseline and 6 months after surgery	No
Secondary	Change from baseline in Oswestry Disability index at 12 months	Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery.	baseline and 12 months after surgery	No
Secondary	Change from baseline in Oswestry Disability index at 24 months	Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery.	baseline and 24 months after surgery	No
Secondary	Return to work	Time off of work and whether patient returned restricted or unrestricted	3 months after surgery	No
Secondary	Return to work	Time off of work and whether patient returned restricted or unrestricted	6 months after surgery	No
Secondary	Return to work	Time off of work and whether patient returned restricted or unrestricted	12 months after surgery	No
Secondary	Return to work	Time off of work and whether patient returned restricted or unrestricted	24 months after surgery	No
Secondary	Return to normal/usual activity	Time between surgery and resuming normal activity for patient	3 months after surgery	No
Secondary	Return to normal/usual activity	Time between surgery and resuming normal activity for patient	6 months after surgery	No
Secondary	Return to normal/usual activity	Time between surgery and resuming normal activity for patient	12 months after surgery	No
Secondary	Return to normal/usual activity	Time between surgery and resuming normal activity for patient	24 months after surgery	No
Secondary	Complications		4 weeks after surgery	Yes
Secondary	Complications		3 months after surgery	Yes
Secondary	Complications		6 months after surgery	Yes
Secondary	Complications		12 months after surgery	Yes
Secondary	Complications		24 months after surgery	Yes

External Links

•   DC2 Healthcare
•   NOC2 Healthcare
•   NRIOM