Minimally Invasive Posterior Decompression of the Cervical Spine

NCT06995300 | Recruiting

• 1 other identifier: NS12-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 months after surgery

Secondary Outcomes (9)

• Change from baseline in Japanese Orthopaedic Association scale

  3 months and 12 months postoperatively

• Change from baseline in Neck Disability Index

  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

  2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

• Change in the cross-sectional area of the dural sac, mm2

  12 months postoperatively

• Change from baseline in cervical balance parameters

  3 months and 12 months postoperatively

Study Arms (1)

Cohort

OTHER

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

Procedure: minimally invasive decompression via the posterior approach

Interventions

minimally invasive decompression via the posterior approach PROCEDURE

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

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• N.N. Priorov National Medical Research Center of Traumatology and Orthopedics: lead

Study Sites (1)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

RECRUITING

Central Study Contacts

Aleksandr Krutko, MD, PhD

CONTACT

+7 495 744 40 11; ortho-ped@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 29, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)