Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation

  • STATUS
    Recruiting
  • End date
    Feb 10, 2026
  • participants needed
    350
  • sponsor
    Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Updated on 19 February 2024

Summary

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.

Details
Condition Slipped disc
Age 18years - 60years
Treatment Preoperative risk estimation of disc herniation recurrence
Clinical Study IdentifierNCT04254250
SponsorNovosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Radicular leg pain with or without back pain
Symptoms persisting for at least four weeks prior to surgery
Given written Informed Consent
Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements
Visual Analogue Scale score at least 40/100 at baseline

Exclusion Criteria

More than one symptomatic level requiring multilevel surgical decompression
Stenosis any etiology at the same level
Spondylolisthesis any etiology at the same level
Prior lumbar spinal surgery at any level
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
Concurrent participation in another clinical study that may confound study results
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