Lumbar Degenerative DiseaseNCT06075966
The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease
A study testing Non-fusion group and Fusion group in people with Lumbar Degenerative Disease, run by Qianfoshan Hospital at 2 sites in China.
Trial summary
Lumbar degenerative diseases such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSSS) are common and frequently encountered in orthopaedics. With the acceleration of the aging process of society, their incidence rate increases year by year. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Degenerative Disease
- What is being tested?
- Non-fusion group and Fusion group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2020to 31 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient's clinical manifestations, physical examination, and imaging data all support the diagnosis of degenerative lumbar spondylosis
- Those who have undergone strict and formal conservative treatment for at least 3 months before surgery and have no significant improvement in symptoms
- Preoperative imaging examination showed single responsible segment protrusion or protrusion leading to segment stenosis
- Surgeries are performed by the same chief surgeon.
Who cannot join
- Lumbar instability, lumbar spondylolisthesis above grade II
- Patients with severe osteoporosis, tuberculosis, or tumors
- Systemic diseases that affect surgical treatment and medication, such as heart disease, liver disease, and kidney disease
- Patients with mental illness, poor compliance, and inability to cooperate in completing follow-up
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Hao-Xuan Zhang
Jinan, Shandong, 250000
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Lumbar degenerative diseases such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSSS) are common and frequently encountered in orthopaedics. With the acceleration of the aging process of society, their incidence rate increases year by year. At present, conservative treatment is the preferred choice for this type of disease, and surgical treatment is feasible in cases where conservative treatment is ineffective. The main surgical methods include simple laminectomy and nucleus pulposus removal, intervertebral fusion and internal fixation, intervertebral disc replacement, and non fusion surgery. Simple nucleus pulposus removal surgery has drawbacks such as loss of intervertebral height and foramen height, which can affect spinal stability; Intervertebral fusion and internal fixation surgery has the problem of accelerating adjacent segment degeneration; The current therapeutic effect of lumbar disc replacement is not yet clear, and the technology is not yet mature. In response to the shortcomings of the above surgical methods, the advancement of science and technology has driven the development of spinal surgery, and a new surgical concept has emerged - spinal non fusion fixation technology. The INTRA-Spine dynamic stability system between vertebral lamina is one of the non fusion technologies of the spine. The core concept of this technology is to provide dynamic fixation on the basis of sufficient decompression of nerves, with the rotation center located between the vertebral lamina, which is closer to the normal movement center of the lumbar spine. It simulates the normal physiological structure of the lumbar spine with minimal damage and trauma, and maximizes the preservation of surgical segment mobility while maintaining spinal stability, Reducing stress concentration in adjacent segments caused by local fusion, thereby reducing the acceleration of adjacent segment degeneration, theoretically has good clinical and imaging efficacy.
Read the detailed description
Retrospective analysis of patients admitted to the Department of Orthopedic and Spinal Surgery of our hospital who underwent the INTRA Spine dynamic stabilization system and lumbar fusion technology for the treatment of lumbar degenerative diseases. General, clinical, and imaging data were collected before and 7 days, 6 months, and 12 months after surgery. The general information of the patient includes gender, age, course of disease, conservative treatment time, surgical time, nail/implant placement time, bleeding volume, and length of hospital stay; The clinical treatment effect was evaluated using the visual analogue VAS score for low back and leg pain, the Japanese Orthopedic Association's JOA score for evaluation of treatment, and the Oswestry Dysfunction Index questionnaire ODI score; The imaging data includes measuring the lateral position of the surgical segment and adjacent segments through lumbar lateral X-ray films, the Cobb angle, flexion and extension range of motion (ROM), intervertebral disc height, and intervertebral foramen height in the over extension and over flexion positions. The optimal measurement angle value is used, and each measurement data is measured three times and its mean is taken. Perform analysis of variance (intra group follow-up time) and t-test (inter group) on the obtained data using statistical software SPSS; Statistics and analysis of clinical efficacy and imaging manifestations.This clinical study has a funding of 50000 RMB.
- Conditions
- Lumbar Degenerative Disease
- Being tested
- Non-fusion group, Fusion group
- Keywords
- INTRA Spine system, dynamic stabilization, non-fusion, Lumbar degeneration, Lumbar range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-fusion groupOther
Patients who have undergone the INTRA-Spine dynamic stabilization system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University.
Fusion groupOther
Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University
| Study group | Role | What they receive |
|---|---|---|
| Non-fusion group | Experimental | Patients who have undergone the INTRA-Spine dynamic stabilization system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. Receives: Other: Non-fusion group; Other: Fusion group |
| Fusion group | Active comparator | Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University. Receives: Other: Non-fusion group; Other: Fusion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 2 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: 2 Years
Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position
Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position
Measured: 2 Years
Secondary outcomes (3)
ROM,range of motion
range of motion
Measured: 2 Years
posterior disc height, PDH
posterior disc height
Measured: 2 years
foraminal height ,FH
foraminal height
Measured: 2 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 start1 Jan 2020
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao-Xuan Zhang, Ph.D/MD, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075966
- Sponsor's protocol ID
- INTRA Spine
- Status last verified
- Jan 2025
- First submitted
- 16 Sep 2023
- Last updated
- 29 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease
- ClinicalTrials.gov ID
- NCT06075966
- Acronym / sponsor ID
- INTRA Spine
- Conditions
- Lumbar Degenerative Disease
- Keywords
- INTRA Spine system, dynamic stabilization, non-fusion, Lumbar degeneration, Lumbar range of motion
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (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 diseases such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSSS) are common and frequently encountered in orthopaedics. With the acceleration of the aging process of society, their incidence rate increases year by year. At present, conservative treatment is the preferred choice for this type of disease, and surgical treatment is feasible in cases where conservative treatment is ineffective. The main surgical methods include simple laminectomy and nucleus pulposus removal, intervertebral fusion and internal fixation, intervertebral disc replacement, and non fusion surgery. Simple nucleus pulposus removal surgery has drawbacks such as loss of intervertebral height and foramen height, which can affect spinal stability; Intervertebral fusion and internal fixation surgery has the problem of accelerating adjacent segment degeneration; The current therapeutic effect of lumbar disc replacement is not yet clear, and the technology is not yet mature. In response to the shortcomings of the above surgical methods, the advancement of science and technology has driven the development of spinal surgery, and a new surgical concept has emerged - spinal non fusion fixation technology. The INTRA-Spine dynamic stability system between vertebral lamina is one of the non fusion technologies of the spine. The core concept of this technology is to provide dynamic fixation on the basis of sufficient decompression of nerves, with the rotation center located between the vertebral lamina, which is closer to the normal movement center of the lumbar spine. It simulates the normal physiological structure of the lumbar spine with minimal damage and trauma, and maximizes the preservation of surgical segment mobility while maintaining spinal stability, Reducing stress concentration in adjacent segments caused by local fusion, thereby reducing the acceleration of adjacent segment degeneration, theoretically has good clinical and imaging efficacy.
Detailed description
Retrospective analysis of patients admitted to the Department of Orthopedic and Spinal Surgery of our hospital who underwent the INTRA Spine dynamic stabilization system and lumbar fusion technology for the treatment of lumbar degenerative diseases. General, clinical, and imaging data were collected before and 7 days, 6 months, and 12 months after surgery. The general information of the patient includes gender, age, course of disease, conservative treatment time, surgical time, nail/implant placement time, bleeding volume, and length of hospital stay; The clinical treatment effect was evaluated using the visual analogue VAS score for low back and leg pain, the Japanese Orthopedic Association's JOA score for evaluation of treatment, and the Oswestry Dysfunction Index questionnaire ODI score; The imaging data includes measuring the lateral position of the surgical segment and adjacent segments through lumbar lateral X-ray films, the Cobb angle, flexion and extension range of motion (ROM), intervertebral disc height, and intervertebral foramen height in the over extension and over flexion positions. The optimal measurement angle value is used, and each measurement data is measured three times and its mean is taken. Perform analysis of variance (intra group follow-up time) and t-test (inter group) on the obtained data using statistical software SPSS; Statistics and analysis of clinical efficacy and imaging manifestations.This clinical study has a funding of 50000 RMB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-fusion group | Experimental | Other: Non-fusion group, Other: Fusion groupPatients who have undergone the INTRA-Spine dynamic stabilization system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. |
| Fusion group | Active comparator | Other: Non-fusion group, Other: Fusion groupPatients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient's clinical manifestations, physical examination, and imaging data all support the diagnosis of degenerative lumbar spondylosis
- Those who have undergone strict and formal conservative treatment for at least 3 months before surgery and have no significant improvement in symptoms
- Preoperative imaging examination showed single responsible segment protrusion or protrusion leading to segment stenosis
- Surgeries are performed by the same chief surgeon.
Key exclusion criteria (4 listed)
- Lumbar instability, lumbar spondylolisthesis above grade II
- Patients with severe osteoporosis, tuberculosis, or tumors
- Systemic diseases that affect surgical treatment and medication, such as heart disease, liver disease, and kidney disease
- Patients with mental illness, poor compliance, and inability to cooperate in completing follow-up
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 |
|---|---|---|
| Non-fusion groupPatients who have undergone the INTRA-Spine dynamic stabilization system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. | Other | Fusion group, Non-fusion group |
| Fusion groupPatients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University | Other | Fusion group, Non-fusion group |
Primary outcome
VAS
Time frame: 2 Years
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.
JOA
Time frame: 2 Years
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.
Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position
Time frame: 2 Years
Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position
3 secondary outcomes
ROM,range of motion
Time frame: 2 Years
posterior disc height, PDH
Time frame: 2 years
foraminal height ,FH
Time frame: 2 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 29 Jan 2025.
- Individual participant dataSharing planned: No
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-fusion group and Fusion group in people with Lumbar Degenerative Disease, run by Qianfoshan Hospital at 2 sites 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 29 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 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 2 Years). The study lists 3 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 29 Jan 2025.