TerminatedNot Applicable

Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc

Stopped: Investigator Moved Institutions

United States200 participantsStarted 2015-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient equal to or greater than 18 years old.
✓. Patients with single level para-central herniated discs from L1-S1.
✓. VAS (Visual Analog Scale) leg \> 40 mm.
✓. Leg pain must be greater than back pain.
✓. Minimum 6 weeks conservative treatment unless motor strength U\< U4/5 and or deteriorating neurologic function.

Exclusion criteria

✕. Lateral/subarticular, far lateral disc herniations
✕. Multi-focal (multi modal) disc herniations
✕. Symptomatic multiple level disc herniations
✕. Active infection either spinal or otherwise
✕. Prior history of lumbar spinal infection at any level
✕. Spinal tumor in lumbar region
✕. Dynamic (any grade) or fixed spondylolisthesis more than 3mm
✕. Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level

What they're measuring

Leg pain as assessed by VAS score

Timeframe: 2 years

Trial details

NCT IDNCT02441959

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07

View on ClinicalTrials.gov More Lumbar Disc Herniation trials