Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

NCT02385968 | Terminated

• 1 other identifier: S-20140085
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes. A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.

Conditions

Lumbar Disc Herniations

Keywords

Modic; Microbiology; Immunology

Outcome Measures

Primary Outcomes (1)

• Bacterial growth on a per-patient basis

  at time of surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with MRI-confirmed lumbar disc herniation. Lumbar disc herniation. Age between 18 and 65 years. No prior spine surgery. No diagnosed dementia.

You may qualify if:

• MRI-confirmed lumbar disc herniation.
• Age between 18 and 65 years.
• No prior spine surgery.
• No diagnosed dementia.

You may not qualify if:

• Antibiotic treatment within the previous two weeks.
• History of alcohol abuse, illicit drug use or drug abuse, or significant mental illness
• Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in treatment with immunosuppressive drugs including high dose steroids or cyclosporine.
• Concurrent infections (infections of skin, urinary tract infection, other skin diseases, e.g. Acne vulgaris).
• Previous epidural instrumentation.
• Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• Vejle Hospital: collaborator

Study Sites (1)

Middelfart Spinesurgery research department

Middelfart, Region Syddanmark, 5500, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies of Nucleus

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen H. Hansen

  Sygehus Lillebaelt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research nurse

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 11, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

DK (1)