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NCT Number: NCT06995300

Minimally Invasive Posterior Decompression of the Cervical Spine

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cervical Degenerative Disc Disease Cervical Stenosis Posterior Spine Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

minimally invasive decompression via the posterior approach

Procedure

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

Primary outcomes

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

    Time frame: 3 months after surgery

    To observe the change in the cross-sectional area of the dural sac by MRI

Secondary outcomes

  1. Change from baseline in Japanese Orthopaedic Association scale

    Time frame: 3 months and 12 months postoperatively

    To observe the change from baseline in Japanese Orthopaedic Association scale at 3 months after surgery (0 points - the severest myelopathy, 17 points - no myelopathy)

  2. Change from baseline in Neck Disability Index

    Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively

    To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active)

  3. Change from baseline in The Health Transition Item from SF-36

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

    To observe the change of The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.'')

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

    Time frame: 12 months postoperatively

    To observe the change in the cross-sectional area of the dural sac by MRI

  5. Change from baseline in cervical balance parameters

    Time frame: 3 months and 12 months postoperatively

    To observe the change of regional balance parameters - Cervical Lordosis - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees

  6. Change from baseline in cervical balance parameters

    Time frame: 3 months and 12 months postoperatively

    To observe the change of regional balance parameters - Segmental Lordosis - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees

  7. Change from baseline in cervical balance parameters

    Time frame: 3 months and 12 months postoperatively

    To observe the change of regional balance parameters - C2-C7 Sagittal Vertical Axis - - by sagittal scans of cervical spine by X-Ray compared to baseline, in degrees

  8. Adverse Events

    Time frame: during study, an average of 1 year

    Document Adverse Events (incl. adverse events related to device) occurrence throughout the study

  9. Change from baseline in Numeric Pain Rating Scale

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

    To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Minimally Invasive Isolated Decompression From the Posterior Approach for Degenerative Spinal Stenosis of the Cervical Spine

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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