NCT01633034

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

14.9 years

First QC Date

June 29, 2012

Last Update Submit

March 19, 2024

Conditions

Intervertebral Disc DegenerationBack Pain

Keywords

intervertebral disc degenerationback painspine surgery

Outcome Measures

Primary Outcomes (1)

  • Inflammatory profile

    At surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Lenox Hill Hospital

Manhattan, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Intervertebral disc tissue Spinal Ligament Tissue Blood serum

MeSH Terms

Conditions

Intervertebral Disc DegenerationBack Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mitchell Levine, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 4, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)