Clinical trial NCT06995300: Minimally Invasive Posterior Decompression of the Cervical Spine
Official title: Minimally Invasive Isolated Decompression From the Posterior Approach for Degenerative Spinal Stenosis of the Cervical Spine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Degenerative Disc Disease
Cervical Stenosis
Posterior Spine Surgery
Lead sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility 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).

Primary outcomes:
measure: Change in the cross-sectional area of the dural sac, mm2
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Change from baseline in Japanese Orthopaedic Association scale
timeFrame: 3 months and 12 months postoperatively
measure: Change from baseline in Neck Disability Index
timeFrame: 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively
measure: Change from baseline in The Health Transition Item from SF-36
timeFrame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
measure: Change in the cross-sectional area of the dural sac, mm2
timeFrame: 12 months postoperatively
measure: Change from baseline in cervical balance parameters
timeFrame: 3 months and 12 months postoperatively
measure: Change from baseline in cervical balance parameters
timeFrame: 3 months and 12 months postoperatively
measure: Change from baseline in cervical balance parameters
timeFrame: 3 months and 12 months postoperatively
measure: Adverse Events
timeFrame: during study, an average of 1 year
measure: Change from baseline in Numeric Pain Rating Scale
timeFrame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Priorov National Medical Research Center of Traumatology and Orthopedics
Study officials:
References: