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

NCT ID: NCT02441959

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-07-31

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.

Conditions

Lumbar Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Discectomy

Randomized to Endoscopic Discectomy Lumbar discectomy Endoscopic Intervention type is lumbar endoscopic surgery- no device or drug

Group Type: ACTIVE_COMPARATOR

Lumbar discectomy Endoscopic

Intervention Type: PROCEDURE

Endoscopic Discectomy

Open Discectomy

Randomized to Open Discectomy Lumbar discectomy Open Intervention type is lumbar open surgery- no device or drug

Group Type: ACTIVE_COMPARATOR

Lumbar discectomy Open

Intervention Type: PROCEDURE

Open Discectomy

Open Discectomy-Cross Over Arm

Randomized to Endoscopic Discectomy Cross over to lumbar discectomy open based on surgeons assessment pre or post incision Intervention type is lumbar open surgery- no device or drug

Group Type: OTHER

Lumbar discectomy Open

Intervention Type: PROCEDURE

Open Discectomy

Interventions

Lumbar discectomy Open

Open Discectomy

Intervention Type: PROCEDURE

Lumbar discectomy Endoscopic

Endoscopic Discectomy

Intervention Type: PROCEDURE

Other Intervention Names

Intervention type is lumbar Open surgery- no device or drug; (Intervention type is lumbar endoscopic surgery- no device or drug

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Desert Institute for Spine Care

UNKNOWN

Sponsor Role: collaborator

Trinity Spine Center

UNKNOWN

Sponsor Role: collaborator

Baton Rouge Ortho Clinic

UNKNOWN

Sponsor Role: collaborator

Orthopedic and Neurological Consultants, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James J Yue, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1504015767

Identifier Type: -

Identifier Source: org_study_id