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

Lumbar Disc Herniation Clinical Trial

Official title:

Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02441959
• Other study ID #: 1504015767
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Procedure:
• Lumbar discectomy Open
Open Discectomy
• Lumbar discectomy Endoscopic
Endoscopic Discectomy

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (7)

Lead Sponsor	Collaborator
Yale University	Baton Rouge Ortho Clinic, Desert Institute for Spine Care, Orthopedic and Neurological Consultants, Inc., Trinity Spine Center, University of New Mexico, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg pain as assessed by VAS score		2 years