Minimally Invasive Posterior Decompression of the Cervical Spine

NCT ID: NCT06995300

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-08-31

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.

Conditions

Cervical Degenerative Disc Disease; Cervical Stenosis; Posterior Spine Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort

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

Group Type: OTHER

minimally invasive decompression via the posterior approach

Intervention Type: PROCEDURE

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

Interventions

minimally invasive decompression via the posterior approach

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

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Aleksandr Krutko, MD, PhD

Role: CONTACT

ortho-ped@mail.ru

+7 495 744 40 11

Facility Contacts

Aleksandr Krutko, MD, PhD

Role: primary

ortho-ped@mail.ru

+7 495 744 40 11

Other Identifiers

NS12-03

Identifier Type: -

Identifier Source: org_study_id