Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
NCT ID: NCT04254250
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
386 participants
OBSERVATIONAL
2020-02-10
2026-02-10
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Preoperative risk estimation of disc herniation recurrence
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.
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.
Preoperative risk estimation of disc herniation recurrence
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.
Interventions
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Preoperative risk estimation of disc herniation recurrence
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.
Eligibility Criteria
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Inclusion Criteria
Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;
1. Radicular leg pain with or without back pain;
2. Symptoms persisting for at least four weeks prior to surgery;
3. Given written Informed Consent;
4. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
5. Visual Analogue Scale score at least 40/100 at baseline.
Exclusion Criteria
2. Stenosis any etiology at the same level;
3. Spondylolisthesis any etiology at the same level;
4. Prior lumbar spinal surgery at any level;
5. 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
6. Concurrent participation in another clinical study that may confound study results.
18 Years
60 Years
ALL
No
Sponsors
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Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
OTHER_GOV
Responsible Party
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Locations
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Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, , Russia
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Novosibirsk, , Russia
Countries
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Other Identifiers
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NS02-03
Identifier Type: -
Identifier Source: org_study_id
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