Cervical Degenerative Disc DiseaseNCT06995300
Minimally Invasive Posterior Decompression of the Cervical Spine
A study testing minimally invasive decompression via the posterior approach in people with Cervical Degenerative Disc Disease and Cervical Stenosis, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 1 site in Russia.
Trial summary
Degenerative stenosis of the cervical spinal canal may be caused by the compression of the posterior part of the dural sac and spinal cord by the hypertrophied ligamentum flavum and facet joints, by the compression of the anterior part of the dural sac and spinal cord by the posterior longitudinal ligament, vertebral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Degenerative Disc Disease, Cervical Stenosis, Posterior Spine Surgery
- What is being tested?
- minimally invasive decompression via the posterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 19 May 2025to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old;
- Degenerative symptomatic cervical stenosis caused by posterior compression (hypertrophied ligament flavum and/or hypertrophied facet joints etc.) confirmed by MRI;
- Symptoms persisting for at least 3 months prior to surgery;
- Planned surgical decompression for one and more cervical level;
- Given written Informed Consent;
- Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Who cannot join
- The need for anterior cervical decompression;
- Prior cervical fusion at any level;
- Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- Neck or non-radicular pain of unknown etiology;
- History or presence of any other major neurological disease or condition that may interfere with the study assessments;
- Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, 127299
About this study
Official title: Minimally Invasive Isolated Decompression From the Posterior Approach for Degenerative Spinal Stenosis of the Cervical Spine
Degenerative stenosis of the cervical spinal canal may be caused by the compression of the posterior part of the dural sac and spinal cord by the hypertrophied ligamentum flavum and facet joints, by the compression of the anterior part of the dural sac and spinal cord by the posterior longitudinal ligament, vertebral osteophytes and protrusion/ herniation.
The choice of surgical treatment in such cases is challenging. Posterior decompression and fixation is often proposed, but it is associated with a traumatic posterior approach, a large wound, and blood loss, a high risk of surgery site infections, and also instability of the metal fixation is possible. Also important is the increase in the surgical procedure cost due to the use of metal implants. An excellent alternative to standard posterior decompression and fixation is a method with isolated decompression of the cervical canal via posterior approach, which does not require any metal fixation.
- Being tested
- minimally invasive decompression via the posterior approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive decompression via the posterior approachProcedure or surgery
All patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | All patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine Receives: Procedure: minimally invasive decompression via the posterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the cross-sectional area of the dural sac, mm2
To observe the change in the cross-sectional area of the dural sac by MRI
Measured: 3 months after surgery
Secondary outcomes (9)
Change from baseline in Japanese Orthopaedic Association scale
To observe the change from baseline in Japanese Orthopaedic Association scale at 3 months after surgery (0 points - the severest myelopathy, 17 points - no myelopathy)
Measured: 3 months and 12 months postoperatively
Change from baseline in Neck Disability Index
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active)
Measured: 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively
Change from baseline in The Health Transition Item from SF-36
To observe the change of The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.'')
Measured: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change in the cross-sectional area of the dural sac, mm2
To observe the change in the cross-sectional area of the dural sac by MRI
Measured: 12 months postoperatively
Change from baseline in cervical balance parameters
To observe the change of regional balance parameters - Cervical Lordosis - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees
Measured: 3 months and 12 months postoperatively
Change from baseline in cervical balance parameters
To observe the change of regional balance parameters - Segmental Lordosis - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees
Measured: 3 months and 12 months postoperatively
Change from baseline in cervical balance parameters
To observe the change of regional balance parameters - C2-C7 Sagittal Vertical Axis - - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees
Measured: 3 months and 12 months postoperatively
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
Measured: during study, an average of 1 year
Change from baseline in Numeric Pain Rating Scale
To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)
Measured: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start19 May 2025
- Primary completion1 Jul 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Degenerative Disc DiseaseStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995300
- Sponsor's protocol ID
- NS12-03
- Status last verified
- Jul 2025
- First submitted
- 12 May 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Isolated Decompression From the Posterior Approach for Degenerative Spinal Stenosis of the Cervical Spine
- ClinicalTrials.gov ID
- NCT06995300
- Acronym / sponsor ID
- NS12-03
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and OrthopedicsUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 May 2025 (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.
Degenerative stenosis of the cervical spinal canal may be caused by the compression of the posterior part of the dural sac and spinal cord by the hypertrophied ligamentum flavum and facet joints, by the compression of the anterior part of the dural sac and spinal cord by the posterior longitudinal ligament, vertebral osteophytes and protrusion/ herniation.
The choice of surgical treatment in such cases is challenging. Posterior decompression and fixation is often proposed, but it is associated with a traumatic posterior approach, a large wound, and blood loss, a high risk of surgery site infections, and also instability of the metal fixation is possible. Also important is the increase in the surgical procedure cost due to the use of metal implants. An excellent alternative to standard posterior decompression and fixation is a method with isolated decompression of the cervical canal via posterior approach, which does not require any metal fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Procedure: minimally invasive decompression via the posterior approachAll patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old;
- Degenerative symptomatic cervical stenosis caused by posterior compression (hypertrophied ligament flavum and/or hypertrophied facet joints etc.) confirmed by MRI;
- Symptoms persisting for at least 3 months prior to surgery;
- Planned surgical decompression for one and more cervical level;
- Given written Informed Consent;
Key exclusion criteria (6 listed)
- The need for anterior cervical decompression;
- Prior cervical fusion at any level;
- Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- Neck or non-radicular pain of unknown etiology;
- History or presence of any other major neurological disease or condition that may interfere with the study assessments;
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 decompression via the posterior approachAll patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine. | Procedure or surgery | Cohort |
Primary outcome
Change in the cross-sectional area of the dural sac, mm2
Time frame: 3 months after surgery
To observe the change in the cross-sectional area of the dural sac by MRI
9 secondary outcomes
Change from baseline in Japanese Orthopaedic Association scale
Time frame: 3 months and 12 months postoperatively
Change from baseline in Neck Disability Index
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively
Change from baseline in The Health Transition Item from SF-36
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change in the cross-sectional area of the dural sac, mm2
Time frame: 12 months postoperatively
Change from baseline in cervical balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in cervical balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in cervical balance parameters
Time frame: 3 months and 12 months postoperatively
Adverse Events
Time frame: during study, an average of 1 year
Change from baseline in Numeric Pain Rating Scale
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
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 6 Jul 2026.
- 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.
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 decompression via the posterior approach in people with Cervical Degenerative Disc Disease and Cervical Stenosis, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics 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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. 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?
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?
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 the cross-sectional area of the dural sac, mm2 (time frame: 3 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 6 Jul 2026.