Lumbar Degenerative DiseasesNCT06075979
Correlation Between Microbial Infection and Lumbar Degenerative Disease Based on High-throughput Gene Sequencing
A study testing Lumbar disc herniation and Lumbar spinal stenosis in people with Lumbar Degenerative Diseases and Gene Product Sequence Variation, run by HaoxuanZhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Degenerative Diseases, Gene Product Sequence Variation
- What is being tested?
- Lumbar disc herniation and Lumbar spinal stenosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lumbar degenerative diseases combined with infectious diseases.
- Lumbar degenerative diseases combined with mental diseases.
- Lumbar degenerative diseases combined with metal allergy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hao-Xuan Zhang
Jinan, Shandong, 250000
Hao-Xuan Zhang, Ph.D/MD, +8615275105665, hoho0605@126.com
About this study
Official title: The First Affiliated Hospital of Shandong First Medical University
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.
Read the 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.
- Being tested
- Lumbar disc herniation, Lumbar spinal stenosis
- Keywords
- lumbar degenerative diseases, high-throughput gene sequencing, microbial infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar disc herniationOther
Patients undergoing surgery for lumbar disc herniation
Lumbar spinal stenosisOther
Patients undergoing surgery for lumbar spinal stenosis
| Study group | Role | What they receive |
|---|---|---|
| Lumbar disc herniation group | Experimental | Patients undergoing surgery for lumbar disc herniation Receives: Other: Lumbar disc herniation; Other: Lumbar spinal stenosis |
| Lumbar spinal stenosis group | Experimental | Patients undergoing surgery for lumbar spinal stenosis Receives: Other: Lumbar disc herniation; Other: Lumbar spinal stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of endplate degeneration in lumbar magnetic resonance imaging - Modic classification
Modic degeneration of the vertebral endplate in the lumbar spine refers to a common abnormal signal change in the endplate and subendplate bone on lumbar magnetic resonance imaging after excluding tumors and tuberculosis. It reflects the microscopic changes in tissue biochemistry within the endplate and the manifestations of endplate degeneration. Modic and other scholars have conducted detailed research on it and classified it into three types based on the signal level and pathological and biochemical changes on MRI, as shown in Figure 1. Type I (edema type): Low signal on T1WI, high signal on T2WI, and cracks in the endplate can be found in the granulation tissue of new blood vessels in the bone marrow; Type II (fatty type): High signal on T1WI, equal or slightly high signal on T2WI, adjacent bone marrow tissue replaced by adipocytes, and end plate rupture; Type III (sclerotic type): Low signal on T1WI and T2WI, with sclerosis changes in the endplate and subchondral bone.
Measured: 3 years
Classification of intervertebral disc degeneration -Pfirrmann classification
The Pfirmmann grading system based on sagittal T2WI of lumbar magnetic resonance imaging is a semi quantitative evaluation method for the degree of lumbar disc degeneration, which can display the morphological changes of lumbar disc degeneration. It is currently a widely used and highly recognized grading system for evaluating the degree of lumbar disc degeneration. This grading system was proposed by Pfirmmann in 2001, which evaluates the level of lumbar disc degeneration based on indicators such as signal intensity, disc shape, and intervertebral space changes in the midsagittal position of the T2WI sequence.
Measured: 3 years
General bacterial culture and identification
Collect blood samples from patients before surgery and intervertebral disc tissue after decompression during surgery. Send blood samples and intervertebral disc tissue samples to bacterial culture analysis for microbial species and drug sensitivity, and conduct smear observation, aerobic and anaerobic environment culture identification. The VitekII Compact fully automated microbial identification and drug sensitivity analysis system (BioMerieux, Marcy Ioile, France) was used for bacterial identification and sensitivity testing of commonly used clinical drugs, and the paper diffusion method (K-B method) was used to increase sensitivity testing of commonly used antibiotics such as levofloxacin, polymyxin B, cefoperazone/sulbactam, minocycline, and vancomycin.
Measured: 3 years
High throughput gene sequencing and drug sensitivity analysis of infectious pathogens
Collect blood samples from patients before surgery, and collect intervertebral disc tissue from patients after decompression during surgery using sterile collection tubes. To ensure the comprehensive identification of microbial species, this study plans to simultaneously sequence RNA and DNA using the TIAAmp MicroRNA and DNA Extraction Kit (Beijing Tiangen Biochemical Technology Co., Ltd., China), and extract RNA and DNA from blood samples and intervertebral disc tissue samples according to the instructions in the manual.
For microbial data analysis, use the Sanger method to map the sequencing results in BWA; Convert data to bam format using SAMtools; After using the built-in script of the software for filtering, use IGV software to process the mapping data; Assemble consistent sequences using SAMTools and BCFtools; Visualize using IGV software; Verify the sequencing accuracy of Nanopore MinION by comparing consistent sequences and Sanger method reference sequences.
Measured: 3 years
Secondary outcomes (2)
VAS
The visual analog scale (VAS) is used for pain assessment. It is widely used in clinical practice in China, and the basic method is to use a vernier ruler with a length of about 10cm, marked with 10 scales on one side, with both ends marked as "0" and "10" respectively. A score of 0 indicates painlessness, and a score of 10 represents the most severe pain that cannot be tolerated.
Measured: 3 years
JOA
The Japanese Orthopaedic Association Scores (JOA) is a neurological function scoring system recommended by the Japanese Orthopaedic Association, which includes four parts: upper limb motor function, lower limb motor function, sensory and bladder function, with a total score of 29 points. The lower the score, the more severe the neurological dysfunction.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start2 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaoxuanZhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HaoxuanZhang, Qianfoshan Hospital
- Investigators
- Hao-Xuan Zhang, Ph.D/MD, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075979
- Sponsor's protocol ID
- High-throughput gene
- Status last verified
- Jan 2025
- First submitted
- 18 Sep 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Shandong First Medical University
- ClinicalTrials.gov ID
- NCT06075979
- Acronym / sponsor ID
- High-throughput gene
- Keywords
- lumbar degenerative diseases, high-throughput gene sequencing, microbial infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HaoxuanZhangUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar disc herniation group | Experimental | Other: Lumbar disc herniation, Other: Lumbar spinal stenosisPatients undergoing surgery for lumbar disc herniation |
| Lumbar spinal stenosis group | Experimental | Other: Lumbar disc herniation, Other: Lumbar spinal stenosisPatients undergoing surgery for lumbar spinal stenosis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Lumbar degenerative diseases combined with infectious diseases.
- Lumbar degenerative diseases combined with mental diseases.
- Lumbar degenerative diseases combined with metal allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar disc herniationPatients undergoing surgery for lumbar disc herniation | Other | Lumbar disc herniation group, Lumbar spinal stenosis group |
| Lumbar spinal stenosisPatients undergoing surgery for lumbar spinal stenosis | Other | Lumbar disc herniation group, Lumbar spinal stenosis group |
Primary outcome
Classification of endplate degeneration in lumbar magnetic resonance imaging - Modic classification
Time frame: 3 years
Modic degeneration of the vertebral endplate in the lumbar spine refers to a common abnormal signal change in the endplate and subendplate bone on lumbar magnetic resonance imaging after excluding tumors and tuberculosis. It reflects the microscopic changes in tissue biochemistry within the endplate and the manifestations of endplate degeneration. Modic and other scholars have conducted detailed research on it and classified it into three types based on the signal level and pathological and biochemical changes on MRI, as shown in Figure 1. Type I (edema type): Low signal on T1WI, high signal on T2WI, and cracks in the endplate can be found in the granulation tissue of new blood vessels in the bone marrow; Type II (fatty type): High signal on T1WI, equal or slightly high signal on T2WI, adjacent bone marrow tissue replaced by adipocytes, and end plate rupture; Type III (sclerotic type): Low signal on T1WI and T2WI, with sclerosis changes in the endplate and subchondral bone.
Classification of intervertebral disc degeneration -Pfirrmann classification
Time frame: 3 years
The Pfirmmann grading system based on sagittal T2WI of lumbar magnetic resonance imaging is a semi quantitative evaluation method for the degree of lumbar disc degeneration, which can display the morphological changes of lumbar disc degeneration. It is currently a widely used and highly recognized grading system for evaluating the degree of lumbar disc degeneration. This grading system was proposed by Pfirmmann in 2001, which evaluates the level of lumbar disc degeneration based on indicators such as signal intensity, disc shape, and intervertebral space changes in the midsagittal position of the T2WI sequence.
General bacterial culture and identification
Time frame: 3 years
Collect blood samples from patients before surgery and intervertebral disc tissue after decompression during surgery. Send blood samples and intervertebral disc tissue samples to bacterial culture analysis for microbial species and drug sensitivity, and conduct smear observation, aerobic and anaerobic environment culture identification. The VitekII Compact fully automated microbial identification and drug sensitivity analysis system (BioMerieux, Marcy Ioile, France) was used for bacterial identification and sensitivity testing of commonly used clinical drugs, and the paper diffusion method (K-B method) was used to increase sensitivity testing of commonly used antibiotics such as levofloxacin, polymyxin B, cefoperazone/sulbactam, minocycline, and vancomycin.
High throughput gene sequencing and drug sensitivity analysis of infectious pathogens
Time frame: 3 years
Collect blood samples from patients before surgery, and collect intervertebral disc tissue from patients after decompression during surgery using sterile collection tubes. To ensure the comprehensive identification of microbial species, this study plans to simultaneously sequence RNA and DNA using the TIAAmp MicroRNA and DNA Extraction Kit (Beijing Tiangen Biochemical Technology Co., Ltd., China), and extract RNA and DNA from blood samples and intervertebral disc tissue samples according to the instructions in the manual. For microbial data analysis, use the Sanger method to map the sequencing results in BWA; Convert data to bam format using SAMtools; After using the built-in script of the software for filtering, use IGV software to process the mapping data; Assemble consistent sequences using SAMTools and BCFtools; Visualize using IGV software; Verify the sequencing accuracy of Nanopore MinION by comparing consistent sequences and Sanger method reference sequences.
2 secondary outcomes
VAS
Time frame: 3 years
JOA
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Lumbar Degenerative Diseases
Not yet recruitingObservational study
Comparing Lumbar Fusion With and Without Stress Endplate Augmentation in Patients With Low Bone Mass
Degenerative Lumbar Disease
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruiting
Lumbar Fusion With Nanotube Versus Titanium Cage
Degenerative Disc Disease, Lumbar Fusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao-Xuan Zhang, Ph.D/MD study chair
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar disc herniation and Lumbar spinal stenosis in people with Lumbar Degenerative Diseases and Gene Product Sequence Variation, run by HaoxuanZhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao-Xuan Zhang, Ph.D/MD (+8615275105665, hoho0605@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of endplate degeneration in lumbar magnetic resonance imaging - Modic classification (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.