Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

NCT ID: NCT01633034

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2025-12-31

Brief Summary

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.

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.

Conditions

Intervertebral Disc Degeneration; Back Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

North Shore University Hospital

Manhasset, New York, United States

Lenox Hill Hospital

Manhattan, New York, United States

Countries

United States

Other Identifiers

10-329A

Identifier Type: -

Identifier Source: org_study_id