Spinal DiseaseNCT02187666
NOC2 Spine Registry
An observational study of Spinal Disease, run by DC2 Healthcare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Disease
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients undergoing lumbar or cervical surgery
- Understand and sign informed consent
Who cannot join
- There are no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DC2 Healthcare
Nashville, Tennessee, 37211
Christina R Cook, PhD, 615-712-9574, ccook@dc2healthcare.com
Risa Tyo, PharmD, 615-712-9574, rtyo@dc2healthcare.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Disease
- Keywords
- Cervical, Lumbar, Spine, Spinal Disease
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar | Patients undergoing lumbar spinal surgery | |
| Cervical | Patients undergoing cervical spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
Pain intensity scale taken at baseline and 4 weeks after surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline and 24 months after surgery
Secondary outcomes (24)
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.
Measured: baseline and 4 weeks after surgery
Fusion at 6 months
Measured: 6 months post-op
Length of hospital stay
Date of discharge will be recorded, an average of one to three days
Measured: one to three days following surgery
Revision surgery within 30 days
Measured: 30 days after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Measured: 4 weeks after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Measured: 4 weeks after surgery
Complications
Measured: 24 hours 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 24 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Measured: 3 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Measured: 6 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Measured: 12 months after surgery
Return to work
Time off of work and whether patient returned restricted or unrestricted
Measured: 24 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Measured: 3 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Measured: 6 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Measured: 12 months after surgery
Return to normal/usual activity
Time between surgery and resuming normal activity for patient
Measured: 24 months after surgery
Complications
Measured: 4 weeks after surgery
Complications
Measured: 3 months after surgery
Complications
Measured: 6 months after surgery
Complications
Measured: 12 months after surgery
Complications
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- DC2 Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2), National Research Independent Operations Management
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187666
- Sponsor's protocol ID
- NOC 1001
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products
- ClinicalTrials.gov ID
- NCT02187666
- Acronym / sponsor ID
- NOC 1001
- Conditions
- Spinal Disease
- Keywords
- Cervical, Lumbar, Spine, Spinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- DC2 HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2), National Research Independent Operations Management
- Study start
- Dec 2011
- Primary completion
- Dec 2016 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar | – | –Patients undergoing lumbar spinal surgery |
| Cervical | – | –Patients undergoing cervical spine surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing lumbar or cervical surgery
- Understand and sign informed consent
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
24 secondary outcomes
Change from baseline in Oswestry Disability index at 4 weeks
Time frame: baseline and 4 weeks after surgery
Fusion at 6 months
Time frame: 6 months post-op
Length of hospital stay
Time frame: one to three days following surgery
Revision surgery within 30 days
Time frame: 30 days after surgery
Return to work
Time frame: 4 weeks after surgery
Return to normal/usual activity
Time frame: 4 weeks after surgery
Complications
Time frame: 24 hours after surgery
Change from baseline in Oswestry Disability index at 3 months
Time frame: baseline and 3 months after surgery
Change from baseline in Oswestry Disability index at 6 months
Time frame: baseline and 6 months after surgery
Change from baseline in Oswestry Disability index at 12 months
Time frame: baseline and 12 months after surgery
Change from baseline in Oswestry Disability index at 24 months
Time frame: baseline and 24 months after surgery
Return to work
Time frame: 3 months after surgery
Return to work
Time frame: 6 months after surgery
Return to work
Time frame: 12 months after surgery
Return to work
Time frame: 24 months after surgery
Return to normal/usual activity
Time frame: 3 months after surgery
Return to normal/usual activity
Time frame: 6 months after surgery
Return to normal/usual activity
Time frame: 12 months after surgery
Return to normal/usual activity
Time frame: 24 months after surgery
Complications
Time frame: 4 weeks after surgery
Complications
Time frame: 3 months after surgery
Complications
Time frame: 6 months after surgery
Complications
Time frame: 12 months after surgery
Complications
Time frame: 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- DC2 HealthcareLink provided by the sponsor.
- NRIOMLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease, run by DC2 Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina R Cook, PhD (615-712-9574, ccook@dc2healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Scale (VAS) from baseline at 4 weeks (time frame: baseline and 4 weeks after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.