Lumbar Spinal StenosisNCT06058143
Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation for LSS Combined With Lumbar Instability
A study testing CLIF-LP and TLIF in people with Lumbar Spinal Stenosis and Lumbar Instability, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Instability
- What is being tested?
- CLIF-LP and TLIF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Nov 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80 years old
- Patients diagnosed with clinical symptoms of lumbar spinal stenosis, neurogenic intermittent claudication, the patient's walking ability is highly limited, and the quality of life is severely reduced
- Imaging diagnosis of 1-2 LSS patients, consistent with clinical symptoms
- Lumbar spine instability can be considered if one of the following three criteria is met: ① mechanical back pain with severe (VAS > 7) (pain aggravates with weight bearing). Radiographs of lumbar hyperextension and flexion show a slip of at least 3mm between the two vertebrae, or a rotation Angle of 11°. ③ Degenerative slip
- Formal conservative treatment is ineffective for more than 3 months
- No history of lumbar surgery
- American College of Physicians ASA Grade I or II
- Subjects voluntarily sign informed consent as subjects
Who cannot join
- In patients with significant symptoms of lumbar radiculopathy, the pain from postural changes cannot be relieved
- Bone stenosis, including developmental lumbar spinal stenosis
- Free nucleus pulposus tissue into the spinal canal or cause spinal canal compression of the small joint cyst
- Patients with hypertrophy of the yellow ligament or small joint cyst as the main pressure
- Intervertebral space or posterior facet joints have fused
- Infectious, traumatic and neoplastic diseases of the lumbar spine
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- Patients who are unable to undergo MRI
- Some medical conditions, such as metabolic bone disease, autoimmune disease, poliomyelitis sequelae, osteoporosis, history of poor bone healing, and long-term oral steroids, were determined by the investigators to be unsuitable for inclusion in the study
- Patients with evidence of neurological disorders (such as peripheral neuropathy), neuromuscular disorders (such as multiple sclerosis, Parkinson's disease, etc.), or systemic diseases (such as inflammatory arthritis) that affect bodily function
- The patient has participated in other clinical trials in the past 3 months
- Patients with poor adherence, judged by the researchers to be unable to complete the trial according to the study plan, such as schizophrenia and dementia, did not provide consent to volunteer to participate in the clinical study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation Versus Transforaminal Lumber Interbody Fusion for Lumbar Spinal Stenosis Combined With Lumbar Instability
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Recently, we developed crenel lateral interbody fusion combined with lateral plate fixation(CLIF - LP) for patients with LSS and lumbar instability. This surgical method has many advantages and showed good results for patients with LSS and lumbar instability. Therefore, we propose the following hypothesis: The clinical and imaging efficacy of CLIF-LP in the treatment of LSS patients with lumbar instability is not inferior to that of traditional transforaminal lumber interbody fusion (TLIF).
Read the detailed description
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Recently, we developed crenel lateral interbody fusion combined with lateral plate fixation(CLIF - LP) for patients with LSS and lumbar instability. This surgical method has the advantages of direct view operation, "safe" psoas major approach, application of modified retractor, and lateral plate reinforcement, which not only significantly improves the postoperative lumbar function and nerve function of patients with LSS and lumbar instability, but also significantly reduces related complications, accelerates rehabilitation, and reduces the medical cost of patients.
Therefore, we propose the following hypothesis: The clinical and imaging efficacy of CLIF-LP in the treatment of LSS patients with lumbar instability is not inferior to that of traditional transforaminal lumber interbody fusion (TLIF).
- Conditions
- Lumbar Spinal Stenosis, Lumbar Instability
- Being tested
- CLIF-LP, TLIF
- Keywords
- lumbar spinal stenosis;lumbar instability
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLIF-LPProcedure or surgery
CLIF-LP surgery method was applied
TLIFProcedure or surgery
TLIF surgery method was applied
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients who received CLIF-LP treatment Receives: Procedure: CLIF-LP |
| Group 2 | Active comparator | Patients who received TLIF treatment Receives: Procedure: TLIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability index (ODI)
Lumbar function was assessed by the Oswestry Disability index (ODI) at 24 months after surgery. ODI includes 10 items, including waist and leg pain, personal life care, lifting heavy objects, walking, sitting, standing, sleeping, sexual life, social life, and whether you can travel freely. The total score is 50 points, and the lower the score, the better the function of the lumbar spine.
Measured: 24 months after surgery
Secondary outcomes (3)
Visual analogue scale（VAS）
Visual analogue scale (VAS) was used for pain scores, and mild pain was 0-3 points, which was tolerable; Moderate pain is 4 ~ 6 points, strong pain affects rest, but can be tolerated; Severe pain is a score of 7 to 10, and the patient's pain is intensified and unbearable.
Measured: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
Japanese Orthopaedic Association (JOA)
The JOA lumbar spine score included four aspects: subjective symptoms, clinical signs, daily activities and bladder function. The highest JOA score was 29 and the lowest was 0. The lower the score was, the more severe the symptoms and the more obvious the dysfunction.
Measured: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
EuroQoL-5D-5L
This scale is a multidimensional measure of health-related quality of life, and it is also the most widely used universal utility scale. EQ-5D-5L consists of five dimensions, namely mobility, self-care, daily activities, pain or discomfort, anxiety or depression, each area is rated on a five-point scale (i.e., no problem, mild problem, moderate problem, severe problem, extreme problem), with higher scores indicating worse conditions.
Measured: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Zhang, PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058143
- Sponsor's protocol ID
- Mars515
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Crenel Lateral Interbody Fusion Combined With Lateral Plate Fixation Versus Transforaminal Lumber Interbody Fusion for Lumbar Spinal Stenosis Combined With Lumbar Instability
- ClinicalTrials.gov ID
- NCT06058143
- Acronym / sponsor ID
- Mars515
- Conditions
- Lumbar Spinal Stenosis, Lumbar Instability
- Keywords
- lumbar spinal stenosis;lumbar instability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Sep 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.
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Recently, we developed crenel lateral interbody fusion combined with lateral plate fixation(CLIF - LP) for patients with LSS and lumbar instability. This surgical method has many advantages and showed good results for patients with LSS and lumbar instability. Therefore, we propose the following hypothesis: The clinical and imaging efficacy of CLIF-LP in the treatment of LSS patients with lumbar instability is not inferior to that of traditional transforaminal lumber interbody fusion (TLIF).
Detailed description
At present, interbody fusion is the mainstream treatment for patients with lumbar spinal stenosis (LSS) and lumbar instability. However, the choice of interbody fusion for LSS patients with lumbar instability remains controversial. Recently, we developed crenel lateral interbody fusion combined with lateral plate fixation(CLIF - LP) for patients with LSS and lumbar instability. This surgical method has the advantages of direct view operation, "safe" psoas major approach, application of modified retractor, and lateral plate reinforcement, which not only significantly improves the postoperative lumbar function and nerve function of patients with LSS and lumbar instability, but also significantly reduces related complications, accelerates rehabilitation, and reduces the medical cost of patients.
Therefore, we propose the following hypothesis: The clinical and imaging efficacy of CLIF-LP in the treatment of LSS patients with lumbar instability is not inferior to that of traditional transforaminal lumber interbody fusion (TLIF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: CLIF-LPPatients who received CLIF-LP treatment |
| Group 2 | Active comparator | Procedure: TLIFPatients who received TLIF treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 50-80 years old
- Patients diagnosed with clinical symptoms of lumbar spinal stenosis, neurogenic intermittent claudication, the patient's walking ability is highly limited, and the quality of life is severely reduced
- Imaging diagnosis of 1-2 LSS patients, consistent with clinical symptoms
- Lumbar spine instability can be considered if one of the following three criteria is met: ① mechanical back pain with severe (VAS > 7) (pain aggravates with weight bearing). Radiographs of lumbar hyperextension and flexion show a slip of at least 3mm between the two vertebrae, or a rotation Angle of 11°. ③ Degenerative slip
- Formal conservative treatment is ineffective for more than 3 months
Key exclusion criteria (11 listed)
- In patients with significant symptoms of lumbar radiculopathy, the pain from postural changes cannot be relieved
- Bone stenosis, including developmental lumbar spinal stenosis
- Free nucleus pulposus tissue into the spinal canal or cause spinal canal compression of the small joint cyst
- Patients with hypertrophy of the yellow ligament or small joint cyst as the main pressure
- Intervertebral space or posterior facet joints have fused
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 |
|---|---|---|
| CLIF-LPCLIF-LP surgery method was applied | Procedure or surgery | Group 1 |
| TLIFTLIF surgery method was applied | Procedure or surgery | Group 2 |
Primary outcome
Oswestry Disability index (ODI)
Time frame: 24 months after surgery
Lumbar function was assessed by the Oswestry Disability index (ODI) at 24 months after surgery. ODI includes 10 items, including waist and leg pain, personal life care, lifting heavy objects, walking, sitting, standing, sleeping, sexual life, social life, and whether you can travel freely. The total score is 50 points, and the lower the score, the better the function of the lumbar spine.
3 secondary outcomes
Visual analogue scale（VAS）
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
Japanese Orthopaedic Association (JOA)
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
EuroQoL-5D-5L
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months after surgery
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 28 Sep 2023.
- 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.
Ning Zhang, PhD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing CLIF-LP and TLIF in people with Lumbar Spinal Stenosis and Lumbar Instability, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Zhan Wang, PhD (-8618758586092, wangzhanhz@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability index (ODI) (time frame: 24 months after surgery). 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 28 Sep 2023.