- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633034
Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
March 19, 2024 updated by: Northwell Health
The purpose of the research is to collect and examine spinal disc and ligament tissues to see if there are any biological markers that can be correlated with MRI images to help us learn more about causes of back pain.
Spinal discs are the pillow-like cushions between the bones of the spine.
They act as shock-absorbers for the spine.
Spinal ligaments support the disc structure during movement.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Degenerative disc disease is the most prevalent indication for spine surgery and the major source of back pain in afflicted patients.
Age related degeneration of the intervertebral discs is not the exception, but the rule.
Degenerative changes are associated with weakening of the disc and hypertrophy of the ligamentum flavum in the spine.
The aim of this study is to determine if there are any local or systemic biomarkers that correlate with the severity of degeneration as indicated by radiological examination.
To date, Imaging (XRay, MRI, CT scans) are the most widely used diagnostic tools for identifying degenerated discs.
Physical changes in the disc are also associated with increased secretion and expression of inflammatory mediators in the tissue.
The investigators are interested in measuring both gene and protein level changes of inflammatory mediators in degenerated discs in order to correlate these levels with imaging based indicators of degeneration.
Protein level changes in the disc and ligamentum flavum have yet to be correlated with MRI-derived disc modic changes classification system.
The investigators hypothesize that as the image characteristics of advancing degenerative disease increase, a corresponding change will be present in the secretion (or expression) of specific markers related to inflammatory processes in the disc.
Cytokines found to be upregulated in disc tissue or ligamentum flavum will also be measured in patient's serum levels to begin developing a systemic diagnostic method for detecting disc degeneration.
Study Type
Observational
Enrollment (Estimated)
200
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
- Name: Mitchell Levine, MD
- Phone Number: 212-434-3900
- Email: mlevine@northwell.edu
Study Locations
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-
New York
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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Manhattan, New York, United States, 10021
- Lenox Hill Hospital
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects who meet inclusion criteria will be recruited from the patients undergoing surgery at The North Shore University Hospital and at Lenox Hill Hospital.
Description
Inclusion Criteria:
- 18 years of age or older
- Patients requiring surgery in lumbar spine region (L1-L2 to L5-S1)
- Potential procedures: Spinal stenosis, discectomy, laminectomy, lumbar fusion, disc herniation.
Exclusion Criteria:
- Patients requiring revision surgery in lumbar spine
- Patients who have had a discography procedure performed at the same disc level as the one being operated on.
- Known inflammatory conditions- Rheumatoid arthritis, Osteomyelitis, Discitis, Gout, Ankylosing spondylitis, and other infections.
- Oncologic conditions- any history of cancer of any type.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inflammatory profile
Time Frame: At surgery
|
At surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mitchell Levine, MD, Northwell Health
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
January 1, 2011
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
June 29, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (Estimated)
July 4, 2012
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-329A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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