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The Study will be conducted in another research center. The Sponsor has changed.
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| Name | Class |
|---|---|
| DePuy International | INDUSTRY |
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This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.
The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.
It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive one-level lumbar deformity correction | Procedure | The study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Angle change at lumbar spine segment | Angle between endplates at the treated level of lumbar spine | At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Visual analog scale (VAS) back pain intensity | To observe the improvement of VAS back pain as compared to baseline through follow-up terms. Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain). | 3, 6, 12 months |
| Improvement of Visual analog scale (VAS) leg pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandr V Krutko, PhD, MD | Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan | Principal Investigator |
| 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 improvement of VAS leg pain as compared to baseline through follow-up terms. Visual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain). |
| 3, 6, 12 months |
| Improvement of Oswestry Disability Index (ODI) | To observe the improvement of ODI as compared to baseline through follow-up terms Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 % (the best result, the patient has no limitations in physical activity). Maximum - 100% (the worst result, patient is not physically active at all). | 3, 6, 12 months |
| Fusion rate success | To observe the Fusion rate (I, II, III or IV grade according to Tan). Grade I - complete fusion; Grade II - partial fusion; Grade III - unipolar pseudarthrosis; Grade IV - bipolar pseudarthrosis. | 12 months |
| Range of Motion | To observe the disc mobility at the treated level | At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months |
| Sagittal balance parameters | To observe sagittal balance as compared to baseline | At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months |
| Disc height | To observe disc height at the treated level as compared to baseline | At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months |
| Blood loss | Blood loss | Day of surgery |
| Surgery duration | Surgery duration | Day of surgery |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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