Clinical trial NCT06075979: Correlation Between Microbial Infection and Lumbar Degenerative Disease Based on High-throughput Gene Sequencing
Official title: The First Affiliated Hospital of Shandong First Medical University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Degenerative Diseases
Gene Product Sequence Variation
Keywords: lumbar degenerative diseases
high-throughput gene sequencing
microbial infection
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Primary outcomes:
measure: Classification of endplate degeneration in lumbar magnetic resonance imaging - Modic classification
timeFrame: 3 years
measure: Classification of intervertebral disc degeneration -Pfirrmann classification
timeFrame: 3 years
measure: General bacterial culture and identification
timeFrame: 3 years
measure: High throughput gene sequencing and drug sensitivity analysis of infectious pathogens
timeFrame: 3 years
Secondary outcomes:
measure: VAS
timeFrame: 3 years
measure: JOA
timeFrame: 3 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Hao-Xuan Zhang
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Hao-Xuan Zhang, Ph.D/MD
role: STUDY_CHAIR
References: