Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)NCT03748277
Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
A study testing Decompression, PLIF and MIS TLIF in people with Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis), run by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
- What is being tested?
- Decompression, PLIF and MIS TLIF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteRussia
- Study dates
- 15 Nov 2018to 15 Feb 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment;
- intermittent claudication caused by stenosis of one lumbar spine segment;
- one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment
Who cannot join
- bilateral foraminal lumbar spine stenosis;
- lumbar spine stenosis more than one-level;
- spondylolisthesis II degree and more;
- sagittal imbalance;
- fusion the same lumbar spine segment after surgery previously;
- other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Novosibirsk, 630091
About this study
Official title: Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.
- Being tested
- Decompression, PLIF, MIS TLIF, Screw Fixation
- Keywords
- intraoperative procedures
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecompressionProcedure or surgery
Bilateral decompression
PLIFProcedure or surgery
Traditional open surgery
MIS TLIFProcedure or surgery
On the one side - Wiltse approach, on the other side - percutaneous
Screw FixationProcedure or surgery
Transpedicular Screw Fixation
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive fusion | Experimental | Bilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous Receives: Procedure: Decompression; Procedure: MIS TLIF; Procedure: Screw Fixation |
| Open Fusion | Active comparator | Bilateral decompression, open fusion + screw fixation Receives: Procedure: Decompression; Procedure: PLIF; Procedure: Screw Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result).
Improvement of ODI post-operatively as compared to baseline
Measured: Day of hospital discharge (10-15 day after surgery)
Secondary outcomes (6)
Oswestry Disability Index (ODI)
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result).
Improvement of ODI as compared to baseline
Measured: 3, 6 and 12 months
VAS (back, leg)
Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).
Improvement of VAS back- and leg pain intensity as compared to baseline
Measured: Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months
Surgery duration
Surgery duration, in minutes
Measured: Day of surgery
Blood loss
Blood loss, in milliliter
Measured: Day of surgery
MRI capacity spine canal
Changes of spine canal capacity of spine segment, in sq. cm., as compared to baseline
Measured: Day of hospital discharge (10-15 day after surgery)
Bone fusion
Intervertebral bone fusion formation, in degree (I, II, III or IV degree according to Tan)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start15 Nov 2018
- Primary completion15 Feb 2019
- Study completion15 Feb 2020
Why it stopped: Recruitment terminated, all follow-up visits were canceled due to quarantine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. group - decompression, MIS TLIF + Screw Fixation 2. group - decompression, open fusion + Screw Fixation
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aleksandr V Krutko, PhD, MD, Principal investigator, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748277
- Sponsor's protocol ID
- 15/11/18
- Status last verified
- Feb 2020
- First submitted
- 15 Nov 2018
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
- ClinicalTrials.gov ID
- NCT03748277
- Acronym / sponsor ID
- 15/11/18
- Keywords
- intraoperative procedures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment terminated, all follow-up visits were canceled due to quarantine
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. TsivyanOther government
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 20 Nov 2018 (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 clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. group - decompression, MIS TLIF + Screw Fixation 2. group - decompression, open fusion + Screw Fixation
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive fusion | Experimental | Procedure: Decompression, Procedure: MIS TLIF, Procedure: Screw FixationBilateral decompression using unilateral approach, MIS TLIF + screw fixation percutaneous |
| Open Fusion | Active comparator | Procedure: Decompression, Procedure: PLIF, Procedure: Screw FixationBilateral decompression, open fusion + screw fixation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment;
- intermittent claudication caused by stenosis of one lumbar spine segment;
- one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment
Key exclusion criteria (6 listed)
- bilateral foraminal lumbar spine stenosis;
- lumbar spine stenosis more than one-level;
- spondylolisthesis II degree and more;
- sagittal imbalance;
- fusion the same lumbar spine segment after surgery previously;
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 |
|---|---|---|
| DecompressionBilateral decompression | Procedure or surgery | Minimally invasive fusion, Open Fusion |
| PLIFTraditional open surgery | Procedure or surgery | Open Fusion |
| MIS TLIFOn the one side - Wiltse approach, on the other side - percutaneous | Procedure or surgery | Minimally invasive fusion |
| Screw FixationTranspedicular Screw Fixation | Procedure or surgery | Minimally invasive fusion, Open Fusion |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Day of hospital discharge (10-15 day after surgery)
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI post-operatively as compared to baseline
6 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: 3, 6 and 12 months
VAS (back, leg)
Time frame: Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months
Surgery duration
Time frame: Day of surgery
Blood loss
Time frame: Day of surgery
MRI capacity spine canal
Time frame: Day of hospital discharge (10-15 day after surgery)
Bone fusion
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Recruitment terminated, all follow-up visits were canceled due to quarantine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
Related trials for Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)
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Segmental Decompression Versus Wide Decompression With Fixation for Degenerative Lumbar Canal Stenosis
Degenerative Lumbar Spinal Stenosis
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.
Aleksandr V Krutko, PhD, MD principal investigator
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, Neurosurgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression, PLIF and MIS TLIF in people with Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis), run by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan at 1 site in Russia.
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 6 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: stopped early, as of the sponsor's last update on 14 May 2020. 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 Russia. 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 was stopped early (reason given: Recruitment terminated, all follow-up visits were canceled due to quarantine). 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?
Oswestry Disability Index (ODI) (time frame: Day of hospital discharge (10-15 day 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 14 May 2020.