Lumbar Spine DegenerationNCT04094220
LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis
A study testing Lateral lumbar interbody fusion in people with Lumbar Spine Degeneration and Lumbar Spinal Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spine Degeneration, Lumbar Spinal Stenosis
- What is being tested?
- Lateral lumbar interbody fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male and female patients who are 50 - 80 years of age.
- Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at one or two contiguous lumbar levels between L1 and L5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain.
- Patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment.
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.
Who cannot join
- Patients with lumbar pathologies requiring treatment at more than two levels.
- Patients who have had previous lumbar fusion surgery.
- Patients with congenital lumbar stenosis.
- Patients with radiographic confirmation of Grade IV facet joint disease or degeneration.
- Patients with noncontained or extruded herniated nucleus pulposus.
- Patients with active local or systemic infection.
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- Patients with rheumatoid arthritis or other autoimmune disease.
- Patients who cannot undergo magnetic resonance imaging (MRI).
- Patients who are mentally incompetent.
- Patients with BMI over 30kg/m2 or less than 18 kg/m2.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Medical College Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: A Randomized, Controlled Trial of Lateral Lumbar Interbody Fusion Plus Posterior Decompression or Not for Severe Lumbar Spinal Stenosis
Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. However, whether additional posterior decompression is necessary for these patients is unknown. Radiographic predictors of failed indirect decompression via LLIF is unknown. In current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received LLIF plus posterior decompression and those without posterior decompression.
Read the detailed description
The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. Patients will be followed for one year. Clinical outcomes of the two groups will be compared. And radiographic predictors of failed indirect decompression via LLIF will be analyzed.
- Conditions
- Lumbar Spine Degeneration, Lumbar Spinal Stenosis
- Being tested
- Lateral lumbar interbody fusion
- Keywords
- indirect decompression, lateral interbody fusion, lumbar, direct decompression
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral lumbar interbody fusionProcedure or surgery
LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.
| Study group | Role | What they receive |
|---|---|---|
| Lateral lumbar interbody fusion | Experimental | Patients in this group received lateral lumbar interbody fusion alone. Patients who suffered residual neurologic symptoms postoperatively will received conservative treatment for at least 3 months.Patients were considered to have unsuccessful indirect decompression if they had less than 20% improvement according to the Oswestry Disability Index (ODI) by 3 months postoperatively. Receives: Procedure: Lateral lumbar interbody fusion |
| Lateral lumbar interbody fusion plus posterior decompression | Experimental | Patients in this group received lateral lumbar interbody fusion plus posterior decompression. Receives: Procedure: Lateral lumbar interbody fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
The ODI is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability
Measured: Preoperative, 3-month, 12-month,24-month after surgery
Secondary outcomes (2)
Visual Analogue Scale (VAS)
The VAS is a self-report measure of the intensity of pain (score range 0 - 10 ). A higher score indicates greater pain intensity.
Measured: Preoperative, 3-month, 12-month,24-month after surgery
Zurich Claudication Questionnaire(ZCQ)
The ZCQ is a disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis.The result is expressed as a percentage of the maximum possible score (22.22% - 100%). The score increases with worsening disability.The The ZCQ consists of three subscales: symptom severity scale, physical function scale and patient's satisfaction with treatment scale.
Measured: Preoperative, 3-month, 12-month,24-month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Aug 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DegenerationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients included in this study are with degenerative lumbar stenosis and Schizas's stenosis grades C. Patients who suffered from significant lumbar scoliosis, grade 2 spondylolisthesis, lumbar fracture and prior lumbar surgery are excluded from this study.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fangcai Li, MD, Principal investigator, The Second Affiliated Hospital of Medical College Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094220
- Sponsor's protocol ID
- 2019-161
- Status last verified
- Dec 2020
- First submitted
- 26 Aug 2019
- Last updated
- 29 Dec 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 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Lateral Lumbar Interbody Fusion Plus Posterior Decompression or Not for Severe Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT04094220
- Acronym / sponsor ID
- 2019-161
- Conditions
- Lumbar Spine Degeneration, Lumbar Spinal Stenosis
- Keywords
- indirect decompression, lateral interbody fusion, lumbar, direct decompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Sep 2019 (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.
Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. However, whether additional posterior decompression is necessary for these patients is unknown. Radiographic predictors of failed indirect decompression via LLIF is unknown. In current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received LLIF plus posterior decompression and those without posterior decompression.
Detailed description
The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. Patients will be followed for one year. Clinical outcomes of the two groups will be compared. And radiographic predictors of failed indirect decompression via LLIF will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients included in this study are with degenerative lumbar stenosis and Schizas's stenosis grades C. Patients who suffered from significant lumbar scoliosis, grade 2 spondylolisthesis, lumbar fracture and prior lumbar surgery are excluded from this study.
| Arm | Type | Receives |
|---|---|---|
| Lateral lumbar interbody fusion | Experimental | Procedure: Lateral lumbar interbody fusionPatients in this group received lateral lumbar interbody fusion alone. Patients who suffered residual neurologic symptoms postoperatively will received conservative treatment for at least 3 months.Patients were considered to have unsuccessful indirect decompression if they had less than 20% improvement according to the Oswestry Disability Index (ODI) by 3 months postoperatively. |
| Lateral lumbar interbody fusion plus posterior decompression | Experimental | Procedure: Lateral lumbar interbody fusionPatients in this group received lateral lumbar interbody fusion plus posterior decompression. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients who are 50 - 80 years of age.
- Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at one or two contiguous lumbar levels between L1 and L5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain.
- Patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment.
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Patients with lumbar pathologies requiring treatment at more than two levels.
- Patients who have had previous lumbar fusion surgery.
- Patients with congenital lumbar stenosis.
- Patients with radiographic confirmation of Grade IV facet joint disease or degeneration.
- Patients with noncontained or extruded herniated nucleus pulposus.
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 |
|---|---|---|
| Lateral lumbar interbody fusionLLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression. | Procedure or surgery | Lateral lumbar interbody fusion, Lateral lumbar interbody fusion plus posterior decompression |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Preoperative, 3-month, 12-month,24-month after surgery
The ODI is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability
2 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Preoperative, 3-month, 12-month,24-month after surgery
Zurich Claudication Questionnaire(ZCQ)
Time frame: Preoperative, 3-month, 12-month,24-month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 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. This study is not recruiting at the moment.
Fangcai Li, MD principal investigator
The Second Affiliated Hospital of Medical College Zhejiang 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 Lateral lumbar interbody fusion in people with Lumbar Spine Degeneration and Lumbar Spinal Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 29 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oswestry Disability Index (ODI) (time frame: Preoperative, 3-month, 12-month,24-month 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 29 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.