Symptomatic Lumbar Disc HerniationPhase 3Neuropoint SDNCT01220921
Neurosurgery Patient Outcomes in Treating Spinal Disorders
A Phase 3 study testing Lumbar Discectomy and Single-level lumbar fusion in people with Symptomatic Lumbar Disc Herniation and Symptomatic Grade I Lumbar Spondylolisthesis, run by Greenwich Hospital at 13 sites in 2 countries.
Trial summary
The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Lumbar Disc Herniation, Symptomatic Grade I Lumbar Spondylolisthesis
- What is being tested?
- Lumbar Discectomy and Single-level lumbar fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks
Who cannot join
- History of previous lumbar spine surgery
- Significant motor weakness (3/5) (i.e. foot drop)
- Cancer, infection, or fracture
- Pregnancy
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Johns Hopkins Hospital
Baltimore, Maryland
Lahey Clinic
Burlington, Massachusetts, 01805
Carolina Spine
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
Greenwich Hospital
Greenwich, Connecticut, 06830
University of Wisconsin
Madison, Wisconsin, 53792
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06520
Columbia University - Neurological Institute
New York, New York, 10032
University of Medicine and Dentistry - New Jersey
Newark, New Jersey, 07103
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
University of California - San Francisco
San Francisco, California, 94143
Canada1 site
University of Calgary - Alberta Health Sevices
Calgary, Alberta, T2N-2T9
About this study
The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .
- Being tested
- Lumbar Discectomy, Single-level lumbar fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar DiscectomyProcedure or surgery
Microsurgical removal of disc that is compressing a nerve root
Single-level lumbar fusionProcedure or surgery
pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Microdiscectomy | Experimental | Patients aged 18-80 with symptomatic lumbar disc herniation resulting in single nerve root compression recalcitrant to non-invasive therapies for at least 6 weeks Receives: Procedure: Lumbar Discectomy |
| Single-Level Lumbar Fusion | Experimental | Patients aged 18-80 with symptomatic grade I degenerative or isthmic spondylolisthesis with mechanical back pain with or without radiculopathy recalcitrant to non-invasive therapies for at least 3 months Receives: Procedure: Single-level lumbar fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 version 1
Health-realted quality of life outcome measure
Measured: 1-Year
Site and Physician Compliance
Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments
Measured: 1 Year
Secondary outcomes (5)
Oswestry Disability Index (ODI)
Validated lumbar spine disease-specific outcomes instrument
Measured: 1 Year
Visual Analog Pain Score
Patient-reported pain intensity scored 1-10
Measured: 1 Year
Return to Work
Return to work assessments will be performed at 1,3,6, and 12 months post-operatively
Measured: 1 Year
30 day complications
death, myocardial infarction (MI), pulmonary embolism (PE), readmission, wound infection, new neurological deficit, re-operation
Measured: 30 days
Delayed Surgical Complications
re-operation, fusion complication, problems with hardware, deformity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Lumbar Disc HerniationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greenwich Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Neurological Surgeons
- Investigators
- Zoher Ghogawala, MD FACS, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220921
- Sponsor's protocol ID
- Neuropoint SD
- Acronym
- Neuropoint SD
- Status last verified
- Dec 2015
- First submitted
- 13 Oct 2010
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurosurgery Patient Outcomes in Treating Spinal Disorders
- ClinicalTrials.gov ID
- NCT01220921
- Acronym / sponsor ID
- Neuropoint SD / Neuropoint SD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Greenwich HospitalUniversity, hospital or other
- Collaborators
- American Association of Neurological Surgeons
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Oct 2010 (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 creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Microdiscectomy | Experimental | Procedure: Lumbar DiscectomyPatients aged 18-80 with symptomatic lumbar disc herniation resulting in single nerve root compression recalcitrant to non-invasive therapies for at least 6 weeks |
| Single-Level Lumbar Fusion | Experimental | Procedure: Single-level lumbar fusionPatients aged 18-80 with symptomatic grade I degenerative or isthmic spondylolisthesis with mechanical back pain with or without radiculopathy recalcitrant to non-invasive therapies for at least 3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks
Key exclusion criteria (4 listed)
- History of previous lumbar spine surgery
- Significant motor weakness (3/5) (i.e. foot drop)
- Cancer, infection, or fracture
- Pregnancy
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 DiscectomyMicrosurgical removal of disc that is compressing a nerve root | Procedure or surgery | Lumbar Microdiscectomy |
| Single-level lumbar fusionpedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both. | Procedure or surgery | Single-Level Lumbar Fusion |
Primary outcome
SF-36 version 1
Time frame: 1-Year
Health-realted quality of life outcome measure
Site and Physician Compliance
Time frame: 1 Year
Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments
5 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: 1 Year
Visual Analog Pain Score
Time frame: 1 Year
Return to Work
Time frame: 1 Year
30 day complications
Time frame: 30 days
Delayed Surgical Complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
Related trials for Symptomatic Lumbar Disc Herniation
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
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.
Zoher Ghogawala, MD FACS study director
Yale University
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumbar Discectomy and Single-level lumbar fusion in people with Symptomatic Lumbar Disc Herniation and Symptomatic Grade I Lumbar Spondylolisthesis, run by Greenwich Hospital at 13 sites in 2 countries.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SF-36 version 1 (time frame: 1-Year). The study lists 2 primary outcomes in all. 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 4 Dec 2015.