Actively Recruiting
The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease and the Clinical Effect of Microdiscectomy
Led by Masaryk University · Updated on 2025-08-27
400
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Masaryk University
Lead Sponsor
S
St. Anne's University Hospital Brno, Czech Republic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the role of the bacterium Cutibacterium acnes in the development of degenerative disc disease among patients with lumbar disc herniation who have undergone microdiscectomy as part of their regular medical care. This study includes both retrospective and prospective components to better understand how C. acnes may affect patient outcomes and spinal health. The study involves two main parts. The retrospective part uses data from about 1200 adult patients collected between 2015 and 2024, including clinical, microbiological, and MRI information. The prospective part plans to enroll at least 400 patients undergoing lumbar microdiscectomy, collecting baseline data, perioperative tissue samples for microbiological analysis, and following patients after surgery. Tissue samples will be analyzed for bacterial quantity, types, virulence factors, and antibiotic susceptibility. Participants will have clinical assessments and complete questionnaires before surgery and at follow-up visits 6 weeks, 6 months, and 12 months after surgery. These evaluations include pain scales, disability questionnaires, quality of life assessments, and patient satisfaction measures. Researchers will study the relationships between bacterial presence and clinical outcomes, including pain, disability, and quality of life over time.
CONDITIONS
Brief Title
The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minimum age of 18 years
- MRI of the lumbosacral spine within one month ± 2 weeks before surgery showing disc protrusion, herniation, or free nucleus pulposus sequestration
- Physical exam findings matching MRI including positive straight leg raise test, dermatomal sensory deficits, myotome motor deficits, and diminished deep tendon reflexes
You will not qualify if you...
- Use of antibiotics or corticosteroids in the month before surgery
- Current bacterial or viral infection
- Being immunocompromised
- History of trauma
- Presence of undefined radiological mass
- Diagnosis of inflammatory arthritis
- Other rheumatologic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 month before surgery
Participants provide baseline epidemiological, radiological, and clinical data including survey questionnaires before surgery.
1 visit (in-person)
Duration - Surgery day
Tissue samples of the herniated intervertebral disc are collected during microdiscectomy surgery for microbiological examination.
1 visit (in-person)
Duration - Immediately after tissue collection
Collected tissue samples are analyzed for the presence, quantification, and characteristics of bacteria including Cutibacterium acnes.
No additional visits required
Duration - 12 months after surgery
Participants are evaluated on their clinical condition and surgical outcomes using questionnaires at multiple timepoints after surgery.
3 follow-up visits at 6 weeks, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
St. Anne´s University Hospital Brno
Brno, Czechia, 60200
Actively Recruiting
Research Team
P
Peter Solár, MUDr., Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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