Minimally invasive back-of-neck decompression for cervical stenosis
Minimally Invasive Isolated Decompression From the Posterior Approach for Degenerative Spinal Stenosis of the Cervical Spine
This trial will test a minimally invasive surgery that removes pressure from the back of the neck for adults with degenerative cervical stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | N.N. Priorov National Medical Research Center of Traumatology and Orthopedics Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06995300 on ClinicalTrials.gov |
What this trial studies
This interventional surgical study uses a minimally invasive posterior approach to decompress the cervical spinal canal without placing metal fixation implants. The procedure targets posterior compression caused by hypertrophied ligamentum flavum and facet joints, confirmed by MRI, and can be done at one or more cervical levels. Eligible adults have symptoms for at least three months and must be able to undergo MRI/X-ray and follow scheduled visits. Patients who need anterior decompression, prior cervical fusion, or have other major neurological conditions are excluded, and outcomes will include imaging and clinical follow-up.
Who should consider this trial
Good fit: Adults (18+) with symptomatic degenerative cervical stenosis due to posterior compression confirmed by MRI, symptoms for three or more months, and a plan for posterior decompression are ideal candidates.
Not a fit: Patients who require anterior cervical decompression, have prior cervical fusion, non-radicular pain of unknown cause, major neurological disease, or cannot undergo required MRI/X-ray are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the procedure could relieve spinal cord compression while reducing wound size, blood loss, infection risk, implant-related instability, and overall surgical cost.
How similar studies have performed: Surgical case series have shown that isolated posterior decompression can be effective in selected patients, but robust randomized comparisons with fusion or anterior approaches are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over 18 years old; 2. Degenerative symptomatic cervical stenosis caused by posterior compression (hypertrophied ligament flavum and/or hypertrophied facet joints etc.) confirmed by MRI; 3. Symptoms persisting for at least 3 months prior to surgery; 4. Planned surgical decompression for one and more cervical level; 5. Given written Informed Consent; 6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements. Exclusion Criteria: 1. The need for anterior cervical decompression; 2. Prior cervical fusion at any level; 3. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol; 4. Neck or non-radicular pain of unknown etiology; 5. History or presence of any other major neurological disease or condition that may interfere with the study assessments; 6. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Where this trial is running
Moscow
- Priorov National Medical Research Center of Traumatology and Orthopedics — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Aleksandr Krutko, MD, PhD
- Email: ortho-ped@mail.ru
- Phone: +7 495 744 40 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.