Intervertebral Disc Degeneration, Lumbar Spinal Stenosis
Conditions
Brief summary
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
Interventions
DEVICELumbar fusion
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.
Sponsors
Medtronic
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 years; * Patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment; * Symptoms persisting for at least three months prior to surgery; * 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
* Prior lumbar spinal fusion at any level; * Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study; * Any condition that cannot be treated with mini-invasive unilateral decompression and fusion; * History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis); * Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) | 3 months | To observe the change of ODI as compared to baseline through follow-up terms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fusion rate success | 12 months and 24 months post op | Interbody fusion rate on CT based on Tan grades |
| Change from baseline in Douleur Neuropathique 4 (DN4) | Through 2 years | To observe the change of DN4 as compared to baseline through follow-up terms |
| Change from baseline in The Health Transition Item from SF-36 (HTI Item) | Through 2 years | To observe the change of HTI Item through follow-up terms |
| Change from baseline in Oswestry Disability Index (ODI) | Through 2 years | To observe the change of ODI as compared to baseline through follow-up terms |
| Change from baseline in Clinical Global Impression Of Change (CGIC) scale | Through 2 years | To observe the change of CGIC through follow-up terms |
| Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D) | Through 2 years | To observe the change of EQ-5D as compared to baseline through follow-up terms |
| Cost-effectiveness | 14th day of hospital stay | Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge. |
| Adverse Events | Through 2 years | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study |
| Change from baseline in Numeric Pain Rating Score (NPRS) | Through 2 years | To observe the change of NPRS as compared to baseline through follow-up terms |
Countries
Russia
Outcome results
None listed