Overview
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.
Eligibility
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;
- Prior lumbar spinal fusion at any level;
- Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
- History or presence of any other major neurological disease or condition that may interfere with the study assessments;
- Severe arterial insufficiency of the legs or other peripheral vascular disease;
- Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).