Correlation Between Microbial Infection and Lumbar Degenerative Disease Based on High-throughput Gene Sequencing
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lumbar disc herniation, Lumbar spinal stenosis.
- Who it may be relevant to
- Registry conditions: Lumbar Degenerative Diseases, Gene Product Sequence Variation. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The First Affiliated Hospital of Shandong First Medical University
Overview
Lumbar degenerative disease is one of the most common diseases in orthopedic and spinal surgery. The pathogenesis of lumbar degenerative disease is still unclear, mainly including aging degeneration and biomechanical hypothesis. In our previous research work，the investigators took lumbar disc tissue from patients who underthe investigatorsnt surgical treatment for lumbar degenerative diseases. The investigators found that some patients had low-toxic bacterial infection in the intervertebral disc tissue. Combined with literature and previous studies, it is suggested that microbial infection plays a role in lumbar degenerative diseases. The investigators suggest that microbial infection may be closely related to the occurrence and development of lumbar degenerative diseases, which may cause or even accelerate the degeneration of lumbar intervertebral disc tissue. The current research difficulties are as follows: 1. Low sensitivity and specificity of microbial analysis; 2. It is difficult to distinguish the colonization infection of intervertebral disc tissue microorganisms from the contamination of foreign substances. In view of this, this study intends to use the high-throughput gene sequencing technology of infectious pathogens based on nano single molecule sequencing, double verification of blood samples and intervertebral disc tissue samples, to identify the microbial status of degenerative lumbar disc tissue, and to explore the correlation between lumbar degenerative disease and microbial infection, identifying relevant susceptible microorganisms, which is expected to study the pathogenesis of this susceptible microorganism in the future, and provide new ideas and approaches for the prevention, control and treatment of lumbar degenerative diseases.
Detailed description
This study intends to use the high-throughput gene sequencing technology of infectious pathogens based on nano single molecule sequencing, double verification of blood samples and intervertebral disc tissue samples, to identify the microbial status of degenerative lumbar disc tissue, and to explore the correlation between lumbar degenerative disease and microbial infection, identifying relevant susceptible microorganisms, which is expected to study the pathogenesis of this susceptible microorganism in the future, and provide new ideas and approaches for the prevention, control and treatment of lumbar degenerative diseases.This clinical study has a funding of 50000 RMB.
Interventions
- Other Lumbar disc herniation
Patients undergoing surgery for lumbar disc herniation - Other Lumbar spinal stenosis
Patients undergoing surgery for lumbar spinal stenosis
Primary outcome measures
- Classification of endplate degeneration in lumbar magnetic resonance imaging - Modic classification [Time frame: 3 years]
- Classification of intervertebral disc degeneration -Pfirrmann classification [Time frame: 3 years]
- General bacterial culture and identification [Time frame: 3 years]
- High throughput gene sequencing and drug sensitivity analysis of infectious pathogens [Time frame: 3 years]
Secondary outcome measures (2)
- VAS [Time frame: 3 years]
- JOA [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Patients in the experimental group, aged 18 to 85 years old, have symptoms and imaging data that support the diagnosis of lumbar degenerative diseases (including lumbar disc herniation, lumbar spinal stenosis, and lumbar spondylolisthesis).
- Patients who undergo strict conservative treatment for 3 months before surgery have no significant improvement in symptoms; The control group of patients had no significant lumbar disc degeneration evaluated by imaging, but needed surgical decompression and fusion intervention due to trauma causing lumbar fractures, lumbar tumors, scoliosis.
- The disc organizer can be obtained during surgery.
Exclusion criteria
- Lumbar degenerative diseases combined with infectious diseases.
- Lumbar degenerative diseases combined with mental diseases.
- Lumbar degenerative diseases combined with metal allergy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
China · 1 center
- Hao-Xuan Zhang — Jinan
Identifiers
NCT: NCT06075979 · High-throughput gene