NOC2 Spine Registry

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Recruiting
      • DC2 Healthcare
      • Contact: Christina R Cook, PhD; Phone Number: 615-712-9574; Email: ccook@dc2healthcare.com
      • Contact: Risa Tyo, PharmD; Phone Number: 615-712-9574; Email: rtyo@dc2healthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• There are no specific exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Lumbar; Patients undergoing lumbar spinal surgery
Cervical; Patients undergoing cervical spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications		24 hours after surgery
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
Fusion at 6 months		6 months post-op
Length of hospital stay	Date of discharge will be recorded, an average of one to three days	one to three days following surgery
Revision surgery within 30 days		30 days after surgery
Return to work	Time off of work and whether patient returned restricted or unrestricted	4 weeks after surgery
Return to normal/usual activity	Time between surgery and resuming normal activity for patient	4 weeks after surgery
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
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
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
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
Return to work	Time off of work and whether patient returned restricted or unrestricted	3 months after surgery
Return to work	Time off of work and whether patient returned restricted or unrestricted	6 months after surgery
Return to work	Time off of work and whether patient returned restricted or unrestricted	12 months after surgery
Return to work	Time off of work and whether patient returned restricted or unrestricted	24 months after surgery
Return to normal/usual activity	Time between surgery and resuming normal activity for patient	3 months after surgery
Return to normal/usual activity	Time between surgery and resuming normal activity for patient	6 months after surgery
Return to normal/usual activity	Time between surgery and resuming normal activity for patient	12 months after surgery
Return to normal/usual activity	Time between surgery and resuming normal activity for patient	24 months after surgery
Complications		4 weeks after surgery
Complications		3 months after surgery
Complications		6 months after surgery
Complications		12 months after surgery
Complications		24 months after surgery

Collaborators and Investigators

• Sponsor: DC2 Healthcare
• Collaborators: National Research Independent Operations Management; National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2)

Publications and helpful links

Helpful Links

• DC2 Healthcare
• NRIOM

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Cervical; Spine; Lumbar; Spinal Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: NOC 1001