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The Study will be conducted in another research center. The Sponsor has changed.
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive lumbar fusion | Other |
| |
| Open posterior lumbar fusion | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar fusion | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) | To observe the change of ODI as compared to baseline through follow-up terms | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) | To observe the change of ODI as compared to baseline through follow-up terms | Through 2 years |
| Change from baseline in Numeric Pain Rating Score (NPRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan | Novosibirsk | 630091 | Russia |
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To observe the change of NPRS as compared to baseline through follow-up terms
| 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 | 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 | 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 | Through 2 years |
| Change from baseline in Clinical Global Impression Of Change (CGIC) scale | To observe the change of CGIC through follow-up terms | Through 2 years |
| Fusion rate success | Interbody fusion rate on CT based on Tan grades | 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. | 14th day of hospital stay |
| Adverse Events | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study | Through 2 years |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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