NCT02441959

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Lumbar discectomy Open	Open Discectomy
PROCEDURE	Lumbar discectomy Endoscopic	Endoscopic Discectomy

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-05-12
• Last updated: 2018-08-07

Locations

1 site across 1 country: United States