NOC2 Spine Registry

July 9, 2014 updated by: DC2 Healthcare

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Lumbar
Patients undergoing lumbar spinal surgery
Cervical
Patients undergoing cervical spine surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
Time Frame: baseline and 4 weeks after surgery
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
Time Frame: baseline and 3 months after surgery
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
Time Frame: baseline and 6 months after surgery
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
Time Frame: baseline and 12 months after surgery
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
Time Frame: baseline and 24 months after surgery
Pain intensity scale taken at baseline and 24 months after surgery
baseline and 24 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 24 hours after surgery
24 hours after surgery
Change from baseline in Oswestry Disability index at 4 weeks
Time Frame: baseline and 4 weeks after surgery
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
Time Frame: 6 months post-op
6 months post-op
Length of hospital stay
Time Frame: one to three days following surgery
Date of discharge will be recorded, an average of one to three days
one to three days following surgery
Revision surgery within 30 days
Time Frame: 30 days after surgery
30 days after surgery
Return to work
Time Frame: 4 weeks after surgery
Time off of work and whether patient returned restricted or unrestricted
4 weeks after surgery
Return to normal/usual activity
Time Frame: 4 weeks after surgery
Time between surgery and resuming normal activity for patient
4 weeks after surgery
Change from baseline in Oswestry Disability index at 3 months
Time Frame: baseline and 3 months after surgery
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
Time Frame: baseline and 6 months after surgery
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
Time Frame: baseline and 12 months after surgery
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
Time Frame: baseline and 24 months after surgery
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 Frame: 3 months after surgery
Time off of work and whether patient returned restricted or unrestricted
3 months after surgery
Return to work
Time Frame: 6 months after surgery
Time off of work and whether patient returned restricted or unrestricted
6 months after surgery
Return to work
Time Frame: 12 months after surgery
Time off of work and whether patient returned restricted or unrestricted
12 months after surgery
Return to work
Time Frame: 24 months after surgery
Time off of work and whether patient returned restricted or unrestricted
24 months after surgery
Return to normal/usual activity
Time Frame: 3 months after surgery
Time between surgery and resuming normal activity for patient
3 months after surgery
Return to normal/usual activity
Time Frame: 6 months after surgery
Time between surgery and resuming normal activity for patient
6 months after surgery
Return to normal/usual activity
Time Frame: 12 months after surgery
Time between surgery and resuming normal activity for patient
12 months after surgery
Return to normal/usual activity
Time Frame: 24 months after surgery
Time between surgery and resuming normal activity for patient
24 months after surgery
Complications
Time Frame: 4 weeks after surgery
4 weeks after surgery
Complications
Time Frame: 3 months after surgery
3 months after surgery
Complications
Time Frame: 6 months after surgery
6 months after surgery
Complications
Time Frame: 12 months after surgery
12 months after surgery
Complications
Time Frame: 24 months after surgery
24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DC2 Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Independent Operations Management
National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NOC 1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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