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

Stopped early · Not applicable

Conditions studied: Lumbar Disc Herniation

In brief

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.

Key facts

Study ID

NCT02441959

Run by

Yale University

People needed

200

Starts

2015-06-01

Expected to finish

2018-07-01

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level
• Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)
• Disc herniation which is significantly calcified
• Contra-lateral leg pain U>40 mm
• History of peripheral diabetic neuropathy
• Significant central stenosis with history of neurogenic claudication
• Pregnancy
• Facet cyst on symptomatic side
• Cauda Equina syndrome past or present
• Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures.
• Significant vascular claudication
• History of radiation to the spinal column
• History of malignancy of any type within 2 years of consideration of enrollment

Where it is running

• Yale New Haven Hospital — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.