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Recruiting
NCT04182997
Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
Conditions: Lumbar Disc Herniation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 200
Sponsor: University of Missouri-Columbia
Location: Missouri Orthopaedic Institute Columbia Missouri
Summary
The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.
Eligibility Criteria
Inclusion Criteria:
* Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a clinical assessment indicative of a lumbar disc herniation
* Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
* Radiculopathy present - positive tension signs or sensory/motor neurologic deficits present
* Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation
Exclusion Criteria:
* Concomitant spinal stenosis, segmental instability, or spondylolisthesis
* Previous surgery at the affected level or recurrent herniation
* Underlying disease that may affect response to steroids - immunocompromise, use of chronic steroids or immunosuppression
* Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
* Diagnosis of or symptoms concerning for cauda equina syndrome
Source: ClinicalTrials.gov (NCT04182997). StuddyBuddy aggregates publicly available trial information.