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

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.

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