Health TrialsbyHealthPanel

Minimally Invasive Posterior Decompression of the Cervical Spine

ConditionsCervical Degenerative Disc DiseaseCervical StenosisPosterior Spine Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorN.N. Priorov National Medical Research Center of Traumatology and Orthopedics

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • minimally invasive decompression via the posterior approach

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CohortOther 1 intervention

Trial outcomes

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

Time frame
3 months after surgery

Secondary outcomes

1

Change from baseline in Japanese Orthopaedic Association scale

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)

Time frame
3 months and 12 months postoperatively
2

Change from baseline in Neck Disability Index

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)

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

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

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.'')

Time frame
2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
4

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

Time frame
12 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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