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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 observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively .
It is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High risk recurrence group | Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk. |
| |
| Low risk recurrence group | Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative risk estimation of disc herniation recurrence | Diagnostic Test | Risk estimation of disc herniation recurrence will be evaluated preoperatively, depend on the risk significance each patient will be assigned to one of two groups - with high risk and low risk. Then each patient will undergo conventional one-level microdiscectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Reherniation rate | Rate of lumbar disc reherniation, symptomatic presence of disc herniation confirmed by MRI at the previously operated level and side | at 3 years follow-up term postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6, 12, 18, 24, 30, 36 months follow up |
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Inclusion Criteria:
- Age 18 to 60 years;
Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;
Exclusion Criteria:
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Adult patients with radicular leg pain with or without back pain secondary to single level disc herniation with neural compression confirmed on MRI and symptoms persisting for at least four weeks prior to surgery
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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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| Improvement of Visual analog scale (VAS) leg pain intensity | To observe the improvement of VAS leg pain as compared to baseline through follow-up terms. | 6, 12, 18, 24, 30, 36 months follow up |
| Change from baseline in EQ-5D (EuroQl - 5 dimensional) | To observe change in EQ-5Dl as compared to baseline | 6, 12, 18, 24, 30, 36 months follow up |
| HTI Item (from SF-36) | To observe the HTI Item (from SF-36) as compared to baseline | 6, 12, 18, 24, 30, 36 months follow up |
| Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan |
| Novosibirsk |
| 630091 |
| Russia |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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