The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease

NCT07085247 | Recruiting

• 1 other identifier: NW25J-10-00060
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to clarify the role of the bacterium Cutibacterium acnes in the development of degenerative disc disease in patients with lumbar disc herniation who underwent microdiscectomy as part of their regular medical care.

Conditions

Lumbar Disc Herniation; Lumbar Disc Degeneration; Cutibacterium Acnes; Low Back Pain

Keywords

Cutibacterium acnes; Degenerative disc disease; Low back pain; Microdiscectomy; Clinical outcome

Outcome Measures

Primary Outcomes (1)

• The effect of C. acnes on functional disability in patients after microdiscectomy.

  The primary aim is a questionnaire-based comparison of the dynamics of the functional limitations according to ODI score between patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.

  6 weeks (± 1week) after the operation.

Secondary Outcomes (41)

• The effect of C. acnes on functional disability in patients after microdiscectomy.

  6 months (± 2weeks) after surgery.

• The effect of C. acnes on functional disability in patients after microdiscectomy.

  12 months (± 2weeks) after the operation.

• The effect of C. acnes on radicular pain in patients after microdiscectomy.

  6 weeks (± 1week) after the operation.

• The effect of C. acnes on radicular pain in patients after microdiscectomy.

  6 months (± 2weeks) after the operation.

• The effect of C. acnes on radicular pain in patients after microdiscectomy.

  12 months (± 2weeks) after the operation.

Study Arms (2)

prospective

1. Patient enrollment: We plan to prospectively enroll at least 400 patients with lumbar disc herniation indicated for lumbar microdiscectomy 2. Preoperative data collection: Baseline epidemiological, radiological and clinical data including survey questionnaires will be collected from each patient. 3. Peri-operative tissue collection: Peri-operatively collected tissue samples of the herniated intervertebral disc will be immediately sent for histological examination. 4. Microbiological examination: The presence, quantification, phylotyping of C.acnes and other bacteria, including virulence factors and antimicrobial susceptibility in the collected disc tissue will be examined by a microbiologist. 5. Post-operative follow-up visits: Post-operative clinical status will be assessed using questionnaires at follow-up visits at 6 weeks, 6, and 12 months after surgery

retrospective

All patients in retrospective cohort have completed epidemiologic, MRI or CT, microbiological, and clinical data. The epidemiological data include age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload. The clinical data include microbiological findings from perioperatively collected disc tissue, preoperative spinal MRI, preoperative and postoperative pain intensity according to the visual analog scale (VAS), and functional disability for low back pain quantified by the Oswestry Disability Questionnaire (ODQ). In this part of the project, microbiological findings will be studied together with radiological changes in preoperative MRI and clinical status before and after surgery.

Eligibility Criteria

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

Study Population

We plan to enroll at least 400 patients with lumbar disc herniation indicated for microdiscectomy at the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic. Patients indicated for lumbar microdiscectomy will be prospectively screened, and those who pass the inclusion and exclusion criteria will be asked to sign the Informed Consent form to be enrolled in the study.

You may qualify if:

• minimum age of 18 years
• MRI of the lumbosacral spine performed one month ± 2weeks before surgery showing a disc protrusion, herniation, or free nucleus pulposus sequestration
• matching physical examination findings including positive straight leg raise test, dermatomal sensory deficits, myotome motor deficits, and diminished deep tendon reflexes.

You may not qualify if:

• antibiotics or corticosteroid use the month before surgery
• ongoing bacterial or viral infection
• immunocompromised patient
• trauma
• undefined radiological mass
• inflammatory arthritis
• other rheumatologic diseases.

Sponsors & Collaborators

• Masaryk University: lead
• St. Anne's University Hospital Brno, Czech Republic: collaborator

Study Sites (1)

St. Anne´s University Hospital Brno

Brno, 60200, Czechia

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Peter Solár, MUDr., Ph.D.

CONTACT

+420 770 638 756; peter.solar@fnusa.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: July 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)