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

Yale University

Status: Terminated

Conditions: Lumbar Disc Herniation

Treatments: Procedure: Lumbar discectomy Open; Procedure: Lumbar discectomy Endoscopic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02441959

1504015767

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Endoscopic Discectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Lumbar discectomy Endoscopic

Open Discectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Lumbar discectomy Open

Open Discectomy-Cross Over Arm

Other group

Description:

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

Treatment:

Procedure: Lumbar discectomy Open