The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Novosibirsk, Russia
Change from baseline in Oswestry Disability Index (ODI)
To observe the change of ODI as compared to baseline through follow-up terms
Time frame: 3 months
Change from baseline in Oswestry Disability Index (ODI)
To observe the change of ODI as compared to baseline through follow-up terms
Time frame: Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS)
To observe the change of NPRS as compared to baseline through follow-up terms
Time frame: Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)
To observe the change of EQ-5D as compared to baseline through follow-up terms
Time frame: Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4)
To observe the change of DN4 as compared to baseline through follow-up terms
Time frame: Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
To observe the change of HTI Item through follow-up terms
Time frame: Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale
To observe the change of CGIC through follow-up terms
Time frame: Through 2 years
Fusion rate success
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Interbody fusion rate on CT based on Tan grades
Time frame: 12 months and 24 months post op
Cost-effectiveness
Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.
Time frame: 14th day of hospital stay
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
Time frame: Through 2 years