Clinical trial NCT02441959: Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc
Official title: Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: University of Washington
name: Desert Institute for Spine Care
name: Trinity Spine Center
name: Baton Rouge Ortho Clinic
name: Orthopedic and Neurological Consultants, Inc.
First posted: 2015-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Leg pain as assessed by VAS score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: James J Yue, MD
role: PRINCIPAL_INVESTIGATOR
References: