New Haven, Connecticut 06520


Purpose:

The purpose of this study is to compare the clinical and radiographic outcomes of full endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar herniated discs in which the patient's leg pain is greater than back pain.


Study summary:

The study will be performed utilizing a prospective multi-center randomized model. Approximately 7 centers will be included in the study as listed above. Patients will be informed of clinical trial and asked if they would like to participate. Patients are informed that participation is optional. Patients may withdraw from study any time prior to or after surgery. Patients will be randomized 2:1 ratio endoscopic:open surgery. Both the endoscopic and open surgical techniques are utilized in standard of care. If a subject requires an open surgery approach (based on the surgeons assessment at the time of surgery pre or post incision) after they are randomized to the endoscopic arm, they will be switched to the open arm and included in the open crossover arm of the study. Study procedures will occur at the following time points; Pre-op, 6 wk, 3 mon, 6 mon, 1 yr and 2 yr follow-up.Subjects will complete questionnaires that assess pain level and location, functional capacity, work and health status, medication usage and duration of symptoms.


Criteria:

Inclusion Criteria: 1. Patient equal to or greater than 18 years old. 2. Patients with single level para-central herniated discs from L1-S1. 3. VAS (Visual Analog Scale) leg > 40 mm. 4. Leg pain must be greater than back pain. 5. Minimum 6 weeks conservative treatment unless motor strength U< U4/5 and or deteriorating neurologic function. Exclusion Criteria: 1. Lateral/subarticular, far lateral disc herniations 2. Multi-focal (multi modal) disc herniations 3. Symptomatic multiple level disc herniations 4. Active infection either spinal or otherwise 5. Prior history of lumbar spinal infection at any level 6. Spinal tumor in lumbar region 7. Dynamic (any grade) or fixed spondylolisthesis more than 3mm 8. Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level 9. Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level 10. Presence of unilateral or bilateral pars inter articularis defects (spondylolysis) 11. Disc herniation which is significantly calcified 12. Contra-lateral leg pain U>40 mm 13. History of peripheral diabetic neuropathy 14. Significant central stenosis with history of neurogenic claudication 15. Pregnancy 16. Facet cyst on symptomatic side 17. Cauda Equina syndrome past or present 18. Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures. 19. Significant vascular claudication 20. History of radiation to the spinal column 21. History of malignancy of any type within 2 years of consideration of enrollment


NCT ID:

NCT02441959


Primary Contact:

Principal Investigator
James J Yue, MD
Yale University

James J Yue, MD
Phone: 2037853714
Email: james.yue@yale.edu


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06520
United States

James J Yue, MD
Phone: 203-785-3714
Email: james.yue@yale.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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