Lumbar Disc HerniationNCT02441959
Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc
A study testing Lumbar discectomy Open and Lumbar discectomy Endoscopic in people with Lumbar Disc Herniation, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Lumbar discectomy Open and Lumbar discectomy Endoscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study
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.
Read the 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
- Being tested
- Lumbar discectomy Open, Lumbar discectomy Endoscopic
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar discectomy OpenProcedure or surgery
Also called Intervention type is lumbar Open surgery- no device or drug
Open Discectomy
Lumbar discectomy EndoscopicProcedure or surgery
Also called (Intervention type is lumbar endoscopic surgery- no device or drug
Endoscopic Discectomy
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Discectomy | Active comparator | Randomized to Endoscopic Discectomy Lumbar discectomy Endoscopic Intervention type is lumbar endoscopic surgery- no device or drug Receives: Procedure: Lumbar discectomy Endoscopic |
| Open Discectomy | Active comparator | Randomized to Open Discectomy Lumbar discectomy Open Intervention type is lumbar open surgery- no device or drug Receives: Procedure: Lumbar discectomy Open |
| Open Discectomy-Cross Over Arm | Other | 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 Receives: Procedure: Lumbar discectomy Open |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg pain as assessed by VAS score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Investigator Moved Institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Sponsor
- Investigators
- James J Yue, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441959
- Sponsor's protocol ID
- 1504015767
- Status last verified
- Aug 2018
- First submitted
- 23 Apr 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study
- ClinicalTrials.gov ID
- NCT02441959
- Acronym / sponsor ID
- 1504015767
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator Moved Institutions
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- 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.
- Study start
- Jun 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Discectomy | Active comparator | Procedure: Lumbar discectomy EndoscopicRandomized to Endoscopic Discectomy Lumbar discectomy Endoscopic Intervention type is lumbar endoscopic surgery- no device or drug |
| Open Discectomy | Active comparator | Procedure: Lumbar discectomy OpenRandomized to Open Discectomy Lumbar discectomy Open Intervention type is lumbar open surgery- no device or drug |
| Open Discectomy-Cross Over Arm | Other | Procedure: Lumbar discectomy OpenRandomized 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar discectomy OpenAlso: Intervention type is lumbar Open surgery- no device or drugOpen Discectomy | Procedure or surgery | Open Discectomy, Open Discectomy-Cross Over Arm |
| Lumbar discectomy EndoscopicAlso: (Intervention type is lumbar endoscopic surgery- no device or drugEndoscopic Discectomy | Procedure or surgery | Endoscopic Discectomy |
Primary outcome
Leg pain as assessed by VAS score
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Investigator Moved Institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Lumbar Disc Herniation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Yue, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar discectomy Open and Lumbar discectomy Endoscopic in people with Lumbar Disc Herniation, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator Moved Institutions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg pain as assessed by VAS score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.