Intervertebral Disc DegenerationNCT03908203
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
A study testing Minimally invasive one-level lumbar deformity correction in people with Intervertebral Disc Degeneration and Spinal Fusion, run by Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan at 1 site in Russia.
Trial summary
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia. The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intervertebral Disc Degeneration, Spinal Fusion
- What is being tested?
- Minimally invasive one-level lumbar deformity correction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2020to 1 Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given written Informed Consent;
- Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1;
- Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain;
- Symptoms persisting for at least three months prior to surgery;
- Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Who cannot join
- Lumbar deformation of non-degenerative etiology;
- Spondylolisthesis grade II or higher (25% slip or greater) of any etiology;
- Patient that has already undergone a lumbar fusion surgery;
- Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
- Concurrent participation in another clinical study that may confound study results.
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
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.
The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.
It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.
- Conditions
- Intervertebral Disc Degeneration, Spinal Fusion
- Being tested
- Minimally invasive one-level lumbar deformity correction
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive one-level lumbar deformity correctionProcedure or surgery
The study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Not described Receives: Procedure: Minimally invasive one-level lumbar deformity correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle change at lumbar spine segment
Angle between endplates at the treated level of lumbar spine
Measured: At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)
Secondary outcomes (9)
Improvement of Visual analog scale (VAS) back pain intensity
To observe the improvement of VAS back pain as compared to baseline through follow-up terms.
Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).
Measured: 3, 6, 12 months
Improvement of Visual analog scale (VAS) leg pain intensity
To observe the improvement of VAS leg pain as compared to baseline through follow-up terms.
Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).
Measured: 3, 6, 12 months
Improvement of Oswestry Disability Index (ODI)
To observe the improvement of ODI as compared to baseline through follow-up terms Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 % (the best result, the patient has no limitations in physical activity). Maximum - 100% (the worst result, patient is not physically active at all).
Measured: 3, 6, 12 months
Fusion rate success
To observe the Fusion rate (I, II, III or IV grade according to Tan).
Grade I - complete fusion; Grade II - partial fusion; Grade III - unipolar pseudarthrosis; Grade IV - bipolar pseudarthrosis.
Measured: 12 months
Range of Motion
To observe the disc mobility at the treated level
Measured: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Sagittal balance parameters
To observe sagittal balance as compared to baseline
Measured: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Disc height
To observe disc height at the treated level as compared to baseline
Measured: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Blood loss
Blood loss
Measured: Day of surgery
Surgery duration
Surgery duration
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Oct 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Why it stopped: The Study will be conducted in another research center. The Sponsor has changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
- Sponsor type
- Other government
- Collaborators
- DePuy International
- Responsible party
- Sponsor
- Investigators
- Aleksandr V Krutko, PhD, MD, Principal investigator, Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908203
- Sponsor's protocol ID
- NS02-02
- Status last verified
- Feb 2020
- First submitted
- 6 Apr 2019
- Last updated
- 11 Sep 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 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
- ClinicalTrials.gov ID
- NCT03908203
- Acronym / sponsor ID
- NS02-02
- Conditions
- Intervertebral Disc Degeneration, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Study will be conducted in another research center. The Sponsor has changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. TsivyanOther government
- Collaborators
- DePuy International
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 9 Apr 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.
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.
The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.
It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Procedure: Minimally invasive one-level lumbar deformity correction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Given written Informed Consent;
- Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1;
- Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain;
- Symptoms persisting for at least three months prior to surgery;
- Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Key exclusion criteria (5 listed)
- Lumbar deformation of non-degenerative etiology;
- Spondylolisthesis grade II or higher (25% slip or greater) of any etiology;
- Patient that has already undergone a lumbar fusion surgery;
- Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study
- Concurrent participation in another clinical study that may confound study results.
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 one-level lumbar deformity correctionThe study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion. | Procedure or surgery | Treatment Arm |
Primary outcome
Angle change at lumbar spine segment
Time frame: At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)
Angle between endplates at the treated level of lumbar spine
9 secondary outcomes
Improvement of Visual analog scale (VAS) back pain intensity
Time frame: 3, 6, 12 months
Improvement of Visual analog scale (VAS) leg pain intensity
Time frame: 3, 6, 12 months
Improvement of Oswestry Disability Index (ODI)
Time frame: 3, 6, 12 months
Fusion rate success
Time frame: 12 months
Range of Motion
Time frame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Sagittal balance parameters
Time frame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Disc height
Time frame: At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months
Blood loss
Time frame: Day of surgery
Surgery duration
Time frame: Day of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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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.
Aleksandr V Krutko, PhD, MD principal investigator
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive one-level lumbar deformity correction in people with Intervertebral Disc Degeneration and Spinal Fusion, 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 Sep 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 withdrawn before enrolling participants, so there are no results.
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?
Angle change at lumbar spine segment (time frame: At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)). 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 11 Sep 2020.