Back to resultsFull-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc
Primary Purpose
Lumbar Disc Herniation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar discectomy Open
Lumbar discectomy Endoscopic
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- Patient equal to or greater than 18 years old.
- Patients with single level para-central herniated discs from L1-S1.
- VAS (Visual Analog Scale) leg > 40 mm.
- Leg pain must be greater than back pain.
- Minimum 6 weeks conservative treatment unless motor strength U< U4/5 and or deteriorating neurologic function.
Exclusion Criteria:
- Lateral/subarticular, far lateral disc herniations
- Multi-focal (multi modal) disc herniations
- Symptomatic multiple level disc herniations
- Active infection either spinal or otherwise
- Prior history of lumbar spinal infection at any level
- Spinal tumor in lumbar region
- Dynamic (any grade) or fixed spondylolisthesis more than 3mm
- Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level
- Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level
- Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)
- Disc herniation which is significantly calcified
- Contra-lateral leg pain U>40 mm
- History of peripheral diabetic neuropathy
- Significant central stenosis with history of neurogenic claudication
- Pregnancy
- Facet cyst on symptomatic side
- Cauda Equina syndrome past or present
- Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures.
- Significant vascular claudication
- History of radiation to the spinal column
- History of malignancy of any type within 2 years of consideration of enrollment
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Endoscopic Discectomy
Open Discectomy
Open Discectomy-Cross Over Arm
Arm Description
Randomized to Endoscopic Discectomy Lumbar discectomy Endoscopic Intervention type is lumbar endoscopic surgery- no device or drug
Randomized to Open Discectomy Lumbar discectomy Open Intervention type is lumbar open surgery- no device or drug
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
Outcomes
Primary Outcome Measures
Leg pain as assessed by VAS score
Secondary Outcome Measures
Full Information
NCT ID
NCT02441959
First Posted
April 23, 2015
Last Updated
August 3, 2018
Sponsor
Yale University
Collaborators
University of New Mexico, University of Washington, Desert Institute for Spine Care, Trinity Spine Center, Baton Rouge Ortho Clinic, Orthopedic and Neurological Consultants, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02441959
Brief Title
Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc
Official Title
Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Investigator Moved Institutions
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University of New Mexico, University of Washington, Desert Institute for Spine Care, Trinity Spine Center, Baton Rouge Ortho Clinic, Orthopedic and Neurological Consultants, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Discectomy
Arm Type
Active Comparator
Arm Description
Randomized to Endoscopic Discectomy Lumbar discectomy Endoscopic Intervention type is lumbar endoscopic surgery- no device or drug
Arm Title
Open Discectomy
Arm Type
Active Comparator
Arm Description
Randomized to Open Discectomy Lumbar discectomy Open Intervention type is lumbar open surgery- no device or drug
Arm Title
Open Discectomy-Cross Over Arm
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Lumbar discectomy Open
Other Intervention Name(s)
Intervention type is lumbar Open surgery- no device or drug
Intervention Description
Open Discectomy
Intervention Type
Procedure
Intervention Name(s)
Lumbar discectomy Endoscopic
Other Intervention Name(s)
(Intervention type is lumbar endoscopic surgery- no device or drug
Intervention Description
Endoscopic Discectomy
Primary Outcome Measure Information:
Title
Leg pain as assessed by VAS score
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient equal to or greater than 18 years old.
Patients with single level para-central herniated discs from L1-S1.
VAS (Visual Analog Scale) leg > 40 mm.
Leg pain must be greater than back pain.
Minimum 6 weeks conservative treatment unless motor strength U< U4/5 and or deteriorating neurologic function.
Exclusion Criteria:
Lateral/subarticular, far lateral disc herniations
Multi-focal (multi modal) disc herniations
Symptomatic multiple level disc herniations
Active infection either spinal or otherwise
Prior history of lumbar spinal infection at any level
Spinal tumor in lumbar region
Dynamic (any grade) or fixed spondylolisthesis more than 3mm
Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level
Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level
Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)
Disc herniation which is significantly calcified
Contra-lateral leg pain U>40 mm
History of peripheral diabetic neuropathy
Significant central stenosis with history of neurogenic claudication
Pregnancy
Facet cyst on symptomatic side
Cauda Equina syndrome past or present
Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures.
Significant vascular claudication
History of radiation to the spinal column
History of malignancy of any type within 2 years of consideration of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Yue, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc
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