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The restoration of lumbar lordosis is mandatory during lumbar fusion surgery for degenerative disc disease, since not restoring lumbar lordosis adequately may adversely affect surgical outcomes and the patient's quality of life in the follow-up. Revision surgery to restore segmental lordosis at the level of previous spinal fusion is extremely difficult to do and its performance is usually inferior to that of primary surgery. Need to provide a surgical technique to restore segmental lordosis via a posterior approach, which is especially important after failed previous fusion at the same lumbar level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Other | All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restoring segmental lordosis at the lumbar spine | Procedure | All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lumbar balance parameters | To observe the change from baseline in segmental lordosis at operated level by CT, in degrees | 2 weeks postoperatively (or at day of hospital discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Numeric Pain Rating Scale | To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain) | 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively |
| Change from baseline in Oswestry Disability Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Priorov National Medical Research Center of Traumatology and Orthopedics | Moscow | 127299 | Russia |
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To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active) |
| 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively |
| Change from baseline in The Health Transition Item from SF-36 | To observe the The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.'') | 2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively |
| Change from baseline in lumbar balance parameters | To observe the change from baseline in segmental lordosis at operated level by full body X-Ray, in degrees | 3 months and 12 months postoperatively |
| Change from baseline in lumbar balance parameters | To observe the change from baseline in low lumbar lordosis (L4-S1) by full body X-Ray, in degrees | 3 months and 12 months postoperatively |
| Change from baseline in lumbar balance parameters | To observe the change from baseline in sagittal vertical axis by full body X-Ray, in degrees | 3 months and 12 months postoperatively |
| Change from baseline in lumbar balance parameters | To observe the change from baseline in full balance integrated index by full body X-Ray, in degrees | 3 months and 12 months postoperatively |
| Change from baseline in lumbar balance parameters | To observe the interbody fusion grade by CT , grades by Tan | 12 months postoperatively |
| Adverse Events | Document Adverse Events (incl. adverse events related to device) occurrence throughout the study | during study, an average of 12 months |
| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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