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

NCT ID: NCT06075979

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Lumbar Degenerative Diseases Gene Product Sequence Variation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lumbar disc herniation group

Patients undergoing surgery for lumbar disc herniation

Group Type EXPERIMENTAL

Lumbar disc herniation

Intervention Type OTHER

Patients undergoing surgery for lumbar disc herniation

Lumbar spinal stenosis

Intervention Type OTHER

Patients undergoing surgery for lumbar spinal stenosis

Lumbar spinal stenosis group

Patients undergoing surgery for lumbar spinal stenosis

Group Type EXPERIMENTAL

Lumbar disc herniation

Intervention Type OTHER

Patients undergoing surgery for lumbar disc herniation

Lumbar spinal stenosis

Intervention Type OTHER

Patients undergoing surgery for lumbar spinal stenosis

Interventions

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Lumbar disc herniation

Patients undergoing surgery for lumbar disc herniation

Intervention Type OTHER

Lumbar spinal stenosis

Patients undergoing surgery for lumbar spinal stenosis

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HaoxuanZhang

OTHER

Sponsor Role lead

Responsible Party

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HaoxuanZhang

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hao-Xuan Zhang, Ph.D/MD

Role: STUDY_CHAIR

Shandong First Medical University

Locations

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Hao-Xuan Zhang

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao-Xuan Zhang, Ph.D/MD

Role: CONTACT

+8615275105665

Facility Contacts

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Hao-Xuan Zhang, Ph.D/MD

Role: primary

+8615275105665

Other Identifiers

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High-throughput gene

Identifier Type: -

Identifier Source: org_study_id

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