Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01633034
Recruitment Status : Recruiting
First Posted : July 4, 2012
Last Update Posted : March 14, 2018
Information provided by (Responsible Party):
Mitchell Levine, Northwell Health

June 29, 2012
July 4, 2012
March 14, 2018
January 2011
December 2020   (Final data collection date for primary outcome measure)
Inflammatory profile [ Time Frame: At surgery ]
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Complete list of historical versions of study NCT01633034 on Archive Site
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Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
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.
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.
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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Retention:   Samples Without DNA
Intervertebral disc tissue Spinal Ligament Tissue Blood serum
Non-Probability Sample
Subjects who meet inclusion criteria will be recruited from the patients undergoing surgery at The North Shore University Hospital and at Lenox Hill Hospital.
  • Intervertebral Disc Degeneration
  • Back Pain
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2020
December 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years of age or older
  2. Patients requiring surgery in lumbar spine region (L1-L2 to L5-S1)
  3. Potential procedures: Spinal stenosis, discectomy, laminectomy, lumbar fusion, disc herniation.

Exclusion Criteria:

  1. Patients requiring revision surgery in lumbar spine
  2. Patients who have had a discography procedure performed at the same disc level as the one being operated on.
  3. Known inflammatory conditions- Rheumatoid arthritis, Osteomyelitis, Discitis, Gout, Ankylosing spondylitis, and other infections.
  4. Oncologic conditions- any history of cancer of any type.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Mitchell Levine, MD 212-434-3900
United States
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Plan to Share IPD: No
Mitchell Levine, Northwell Health
Northwell Health
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Principal Investigator: Mitchell Levine, MD Northwell Health
Northwell Health
March 2018