Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis (NCT04594980) | Clinical Trial Compass
CompletedNot Applicable
Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis
Russia96 participantsStarted 2022-01-20
Plain-language summary
The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 40-75 years;
✓. Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1;
✓. Symptoms persisting for at least three months prior to surgery;
✓. Given written Informed Consent Form;
✓. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
✓. Oswestry Disability Index score of at least 40/100 at baseline;
Exclusion criteria
✕. Bilateral foraminal stenosis requiring surgical decompression on both sides;
✕. Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille;
✕. More than one symptomatic level requiring multi-level surgical decompression and/or fusion;
✕. Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
✕. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
✕. Spondylolisthesis grade II or higher of any etiology;
✕
What they're measuring
1
Change from baseline in Oswestry Disability Index (ODI)
Timeframe: 3 months
Trial details
NCT IDNCT04594980
SponsorN.N. Priorov National Medical Research Center of Traumatology and Orthopedics