Minimally Invasive Posterior Decompression of the Cervical Spine

N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

Status: Not yet enrolling

Conditions: Posterior Spine Surgery; Cervical Stenosis; Cervical Degenerative Disc Disease

Treatments: Procedure: minimally invasive decompression via the posterior approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06995300

NS12-03

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cohort

Other group

Description:

All patients will undergo minimally invasive isolated decompression via the posterior approach to the cervical spine

Treatment:

Procedure: minimally invasive decompression via the posterior approach