The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMasaryk University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
antibiotics or corticosteroid use the month before surgery
ongoing bacterial or viral infection
immunocompromised patient
trauma
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: prospective
Group B: retrospective
Trial outcomes
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.
Time frame
6 weeks (± 1week) after the operation.Secondary 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.
Time frame
6 months (± 2weeks) after surgery.2
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.
Time frame
12 months (± 2weeks) after the operation.3
The effect of C. acnes on radicular pain in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of the dynamics of radicular pain according to NRS between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue c
Time frame
6 weeks (± 1week) after the operation.4
The effect of C. acnes on radicular pain in patients after microdiscectomy.
The secondary aim is a questionnaire-based comparison of the dynamics of radicular pain according to NRS between groups with different C. acnes bacterial load and C. acnes isolates in the disc tissue c
Time frame
6 months (± 2weeks) after the operation.Sponsors and contacts
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Masaryk University
Lead sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborator
Source ClinicalTrials.gov