Spinal StenosisNCT04318795
MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis
A study testing minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) in people with Spinal Stenosis, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in terms of clinical outcomes, complications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intermittent claudication with pain or numbness or weakness of lower limb(s) with or without low back pain
- An imaging study (MRI or CT) showing single level lumbar spinal stenosis
Who cannot join
- Insufficient conservative treatment (6 weeks)
- Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
- Previous spinal surgery
- Other comorbid conditions that contraindicating surgery
- Possible pregnancy that contraindicating radiological examination
- Age less than 18 years old
Show all 9Show fewer
- Combination with 2°spondylolisthesis or segmental instability (slip distance >4mm or angle change >10° in dynamic plain film)
- Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
- Equal to or more than two responsible level
About this study
Official title: Minimally Invasive Spinal Decompression (MIS-D) Versus Minimally Invasive Spinal Decompression and Fusion (MIS-TLIF) for the Treatment of Lumbar Spinal Stenosis (LSS): A Prospective Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in terms of clinical outcomes, complications, reoperations, and other perioperative data.
Read the detailed description
Lumbar spinal stenosis (LSS) is one of the most common degenerative spine diseases in older people and is associated with mechanical low back pain, radiculopathy and/or neurological claudication. The results of The Spine Patient Outcomes Research Trial (SPORT) reported that, surgical treatment in these patients led to significantly greater improvement in pain and function than nonsurgical treatment. Nowadays, decompression with instrumented or non-instrumented fusion is commonly practiced which is regarded as the "gold standard" surgery for LSS.
Over the last two decades, several retrospective studies comparing the surgical outcomes of decompression alone and decompression plus fusion for LSS have been published. Most of the studies concluded that decompression plus fusion had better clinical outcomes compared with decompression alone. However, in 2016, two randomized control trials (RCT) about LSS were published in the New England Journal of Medicine (NEJM) and raised some serious questions. The results of both studies showed that fusion did not have much additional value for patients with stable LSS, and moreover, it might be regard as an overcautious and unnecessary treatment, which were contradictory to most of the previous studies.
Over the past few years, minimally invasive spine surgery (MISS) has been improving rapidly due to the development of related instruments, more experienced surgeons, and patients' demands. Compared with open spine surgery, MISS has already proved to be associated with less surgical trauma and rapid recovery with similar clinical outcomes. Minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) have been performed widely for the treatment of LSS. However, there is no previous study comparing MIS-D to MIS-TLIF in terms of clinical outcomes, complications, reoperations, and other perioperative data. Therefore, a randomized controlled trial comparing these 2 common MISS techniques is warranted.
- Conditions
- Spinal Stenosis
- Being tested
- minimally invasive spinal decompression (MIS-D), minimally invasive spinal decompression and fusion (MIS-TLIF)
- Keywords
- lumbar spinal stenosis, minimally invasive spine surgery, decompression, fusion, randomized controlled trial
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive spinal decompression (MIS-D)Procedure or surgery
lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation
minimally invasive spinal decompression and fusion (MIS-TLIF)Procedure or surgery
lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive spinal decompression (MIS-D) | Experimental | lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation Receives: Procedure: minimally invasive spinal decompression (MIS-D) |
| minimally invasive spinal decompression and fusion (MIS-TLIF) | Experimental | lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach Receives: Procedure: minimally invasive spinal decompression and fusion (MIS-TLIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Oswestry Disability Index (ODI) score from baseline
The Oswestry Disability Index (ODI) is widely used to assess chronic low back pain. It contains ten sections including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The ODI is ranging from 0 to 100, with higher scores indicating more disability related to pain.
Measured: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
Secondary outcomes (3)
change in European Quality of Life-5 Dimensions (EQ-5D) from baseline
The EQ-5D is a widely used instrument to assess health-related quality of life. Five questions(Mobility, Self-care, activities of daily living, Pain and Anxiety) are categorical (1-3 scale) and one question is on interval level (0-100).The EQ-5D is ranging from 0 to 1, with a higher score indicating better quality of life.
Measured: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
change in visual analog scales (VAS) from baseline
The VAS score is commonly used for pain assessment, which is ranging from 0 to 10, with higher scores indicating more severe pain
Measured: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
MacNab criteria
The patient is asked to rate his level of well-being, generally after surgery. The patient choose one of the four: Excellent, Good, Fair, Poor.
Measured: 2 month, 6 months, 1 year，2 years and 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318795
- Sponsor's protocol ID
- MIS-D V.s. MIS-TLIF for LSS
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 26 Mar 2020
- 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 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Spinal Decompression (MIS-D) Versus Minimally Invasive Spinal Decompression and Fusion (MIS-TLIF) for the Treatment of Lumbar Spinal Stenosis (LSS): A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04318795
- Acronym / sponsor ID
- MIS-D V.s. MIS-TLIF for LSS
- Conditions
- Spinal Stenosis
- Keywords
- lumbar spinal stenosis, minimally invasive spine surgery, decompression, fusion, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Mar 2020 (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.
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in terms of clinical outcomes, complications, reoperations, and other perioperative data.
Detailed description
Lumbar spinal stenosis (LSS) is one of the most common degenerative spine diseases in older people and is associated with mechanical low back pain, radiculopathy and/or neurological claudication. The results of The Spine Patient Outcomes Research Trial (SPORT) reported that, surgical treatment in these patients led to significantly greater improvement in pain and function than nonsurgical treatment. Nowadays, decompression with instrumented or non-instrumented fusion is commonly practiced which is regarded as the "gold standard" surgery for LSS.
Over the last two decades, several retrospective studies comparing the surgical outcomes of decompression alone and decompression plus fusion for LSS have been published. Most of the studies concluded that decompression plus fusion had better clinical outcomes compared with decompression alone. However, in 2016, two randomized control trials (RCT) about LSS were published in the New England Journal of Medicine (NEJM) and raised some serious questions. The results of both studies showed that fusion did not have much additional value for patients with stable LSS, and moreover, it might be regard as an overcautious and unnecessary treatment, which were contradictory to most of the previous studies.
Over the past few years, minimally invasive spine surgery (MISS) has been improving rapidly due to the development of related instruments, more experienced surgeons, and patients' demands. Compared with open spine surgery, MISS has already proved to be associated with less surgical trauma and rapid recovery with similar clinical outcomes. Minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) have been performed widely for the treatment of LSS. However, there is no previous study comparing MIS-D to MIS-TLIF in terms of clinical outcomes, complications, reoperations, and other perioperative data. Therefore, a randomized controlled trial comparing these 2 common MISS techniques is warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive spinal decompression (MIS-D) | Experimental | Procedure: minimally invasive spinal decompression (MIS-D)lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation |
| minimally invasive spinal decompression and fusion (MIS-TLIF) | Experimental | Procedure: minimally invasive spinal decompression and fusion (MIS-TLIF)lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intermittent claudication with pain or numbness or weakness of lower limb(s) with or without low back pain
- An imaging study (MRI or CT) showing single level lumbar spinal stenosis
Key exclusion criteria (9 listed)
- Insufficient conservative treatment (6 weeks)
- Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
- Previous spinal surgery
- Other comorbid conditions that contraindicating surgery
- Possible pregnancy that contraindicating radiological examination
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 |
|---|---|---|
| minimally invasive spinal decompression (MIS-D)lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation | Procedure or surgery | minimally invasive spinal decompression (MIS-D) |
| minimally invasive spinal decompression and fusion (MIS-TLIF)lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach | Procedure or surgery | minimally invasive spinal decompression and fusion (MIS-TLIF) |
Primary outcome
change in Oswestry Disability Index (ODI) score from baseline
Time frame: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
The Oswestry Disability Index (ODI) is widely used to assess chronic low back pain. It contains ten sections including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The ODI is ranging from 0 to 100, with higher scores indicating more disability related to pain.
3 secondary outcomes
change in European Quality of Life-5 Dimensions (EQ-5D) from baseline
Time frame: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
change in visual analog scales (VAS) from baseline
Time frame: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
MacNab criteria
Time frame: 2 month, 6 months, 1 year，2 years and 5 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) in people with Spinal Stenosis, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. 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?
Results are not available in the source record.
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?
change in Oswestry Disability Index (ODI) score from baseline (time frame: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively). 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 26 Mar 2020.