Correlation Between Microbial Infection and Lumbar Degenerative Disease Based on High-throughput Gene Sequencing

HaoxuanZhang

Status: Enrolling

Conditions: Gene Product Sequence Variation; Lumbar Degenerative Diseases

Treatments: Other: Lumbar spinal stenosis; Other: Lumbar disc herniation

Study type: Interventional

Funder types: Other

Identifiers

NCT06075979

High-throughput gene

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Lumbar disc herniation group

Experimental group

Description:

Patients undergoing surgery for lumbar disc herniation

Treatment:

Other: Lumbar spinal stenosis

Other: Lumbar disc herniation

Lumbar spinal stenosis group

Experimental group

Description:

Patients undergoing surgery for lumbar spinal stenosis

Treatment:

Other: Lumbar spinal stenosis

Other: Lumbar disc herniation