Spinal StenosisRAMPNCT01716182
RAMP Study: A Study Comparing Two Lumbar Fusion Procedures
An observational study of Spinal Stenosis and Spondylolisthesis, run by Baxano Surgical, Inc. at 11 sites in United States.
Trial summary
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- How many people
- 200 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2012to Jul 2014
- Phase
- Observational
- 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
Study population: To be eligible to participate in this study, the subject must meet all of the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Male or female subject that is eligible for both study procedures only at the L4-L5-S1 or L5-S1 levels with bilateral pedicle screws;
- The subject has a diagnosis of one or more of the following conditions at the L4-L5-S1 or L5-S1 levels:
- Spinal stenosis;
- Spondylolisthesis;
- Degenerative Disc Disease (DDD) defined as back pain and/or radicular pain with degeneration of the disc as confirmed by history, physical examination and radiographic studies, either by CT, MRI, plain film, myelography, or discography;
- Adult 18 years of age or older;
- The subject has undergone at least 6 consecutive months of Conservative Care Therapy(ies);
- The subject is able and willing to give written informed consent and to comply with the requirements of this study protocol.
Who cannot join
- Coagulopathy;
- Bowel disease (e.g. Crohn's, ulcerative colitis);
- Severe scoliosis (curves > 60°);
- Sacral agenesis;
- Spondylolisthesis greater than Grade 1 at the L4-L5-S1 levels, or greater than Grade 2 at the L5-S1 level;
- Spinal tumor (or history of sacral tumor);
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- History of fracture at L4, L5 and/or S1 vertebral bodies;
- The subject has undergone a prior fusion procedure of the lumbar spine;
- Osteoporosis; or, if the subject is at high risk for development of osteoporosis, further screening to be conducted at Investigator's discretion;
- Per the Investigator, body weight is exclusionary only if concomitant medical issues are present that preclude the subject from being a candidate for spinal surgery; The subject is a current cigarette smoker;
- For women of childbearing potential, pregnancy at the time of enrollment, or planning to become pregnant during the course of the study;
- The subject has a history of substance abuse (illegal drugs, prescription drugs, or alcohol) that, in the Investigator's opinion, may interfere with protocol assessments and/or the subject's ability to comply with the protocol;
- Per the Investigator, the subject is in poor general health or undergoing any concurrent disease process that would place the subject in excessive risk to surgery (e.g. significant circulatory problems, cardiac disease, history of bowel surgery);
- The subject is participating in another spine study, which, in the opinion of the Investigator, could skew results;
- The subject is involved in litigation related to their back condition;
- The subject is contraindicated to receive either study procedure;
- The subject is contraindicated to receive bilateral pedicle screws;
- The subject has a history of allergy to any component of the devices or biologic material to be implanted in either procedure;
- The subject is a prisoner, transient, or an illegal alien.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, 70808
Indiana Spine Group
Carmel, Indiana, 46032
Cary Orthopaedic Spine Specialists
Cary, North Carolina, 27518
Mayfield Clinic/University of Cincinnati
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Brazos Spine
College Station, Texas, 77845
Danville Orthopedic Clinic, Inc.
Danville, Virginia, 24541
St. Joseph Heritage Healthcare
Fullerton, California, 92835
Cedars-Sinai Medical Center
Los Angeles, California, 90048
LSU Health Sciences Center, Department of Neurosurgery
New Orleans, Louisiana, 70112
UMass Medical Center, Department of Neurosurgery
Worcester, Massachusetts, 01655
About this study
Official title: RAMP Study: A Prospective Randomized Study Comparing Two Lumbar Fusion Procedures
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.
Read the detailed description
Study Treatment Arms:
The transacral lumbar interbody fusion (including 1L+ and 2L+) is a minimally invasive technique that uses a transacral approach to achieve fusion at the L5-S1 or L4-L5-S1 spinal levels. The transforaminal lumbar interbody fusion (TLIF) is performed by using a posterior unilateral or bilateral incision in which the lumbar spine is accessed. Both study procedures are approved for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.
Study Design, Objective:
The study objective is to demonstrate non-inferiority between the transacral lumbar interbody fusion procedure and the transforaminal lumbar interbody fusion procedure (TLIF) by meeting the primary and secondary study endpoints as listed below.
Study design, Endpoints:
Primary Endpoint:
Efficacy: Fusion of the targeted vertebral bodies (L4-L5 or L5-S1) by 24 months as determined by Central Radiographic Reviewer's interpretation of high resolution Computed Tomography (CT) scan.
Secondary Endpoints:
Safety: Incidence of major device-related adverse events and/or failures by 24 months, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
Clinical Effectiveness: A 20% decrease in back pain compared to baseline by 24 months as measured by the Visual Analog Scale (VAS) score.
Clinical Effectiveness: A 20% decrease in disability compared to baseline by 24 months as measured by the Oswestry Disability Index (ODI).
Study Design, Enrollment and Analyses:
Approximately 200 subjects will be enrolled in this study and will receive one of two study treatments in the study. The enrollment period is expected to last approximately 18 months, with a 24 month follow up period. Approximately 15-20 sites will participate, and Investigators must be proficient in both of the lumbar fusion procedures.
Analyses:
Eight evaluations: Pre-Operative, Operative, Discharge, and at 1, 3, 6, 12, and 24 Months.
Safety and efficacy analyses will be performed at all follow-up points during the study as well as a final analysis when all subjects have completed the study.
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transacral lumbar interbody fusion procedure | Not described | |
| transforaminal lumbar interbody fusion procedure (TLIF) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Efficacy: Fusion of the targeted vertebral bodies (L4-L5-S1 or L5-S1) will be assessed individually at 24 months as determined by Central Radiographic Reviewer's (orthopedic surgeon) interpretation of high resolution Computed Tomography (CT) Scan.
Measured: 24 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxano Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Hart, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716182
- Sponsor's protocol ID
- PR-0018
- Acronym
- RAMP
- Status last verified
- Jul 2014
- First submitted
- 24 Oct 2012
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAMP Study: A Prospective Randomized Study Comparing Two Lumbar Fusion Procedures
- ClinicalTrials.gov ID
- NCT01716182
- Acronym / sponsor ID
- RAMP / PR-0018
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baxano Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 29 Oct 2012 (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.
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.
Detailed description
Study Treatment Arms:
The transacral lumbar interbody fusion (including 1L+ and 2L+) is a minimally invasive technique that uses a transacral approach to achieve fusion at the L5-S1 or L4-L5-S1 spinal levels. The transforaminal lumbar interbody fusion (TLIF) is performed by using a posterior unilateral or bilateral incision in which the lumbar spine is accessed. Both study procedures are approved for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.
Study Design, Objective:
The study objective is to demonstrate non-inferiority between the transacral lumbar interbody fusion procedure and the transforaminal lumbar interbody fusion procedure (TLIF) by meeting the primary and secondary study endpoints as listed below.
Study design, Endpoints:
Primary Endpoint:
Efficacy: Fusion of the targeted vertebral bodies (L4-L5 or L5-S1) by 24 months as determined by Central Radiographic Reviewer's interpretation of high resolution Computed Tomography (CT) scan.
Secondary Endpoints:
Safety: Incidence of major device-related adverse events and/or failures by 24 months, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
Clinical Effectiveness: A 20% decrease in back pain compared to baseline by 24 months as measured by the Visual Analog Scale (VAS) score.
Clinical Effectiveness: A 20% decrease in disability compared to baseline by 24 months as measured by the Oswestry Disability Index (ODI).
Study Design, Enrollment and Analyses:
Approximately 200 subjects will be enrolled in this study and will receive one of two study treatments in the study. The enrollment period is expected to last approximately 18 months, with a 24 month follow up period. Approximately 15-20 sites will participate, and Investigators must be proficient in both of the lumbar fusion procedures.
Analyses:
Eight evaluations: Pre-Operative, Operative, Discharge, and at 1, 3, 6, 12, and 24 Months.
Safety and efficacy analyses will be performed at all follow-up points during the study as well as a final analysis when all subjects have completed the study.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transacral lumbar interbody fusion procedure | – | – |
| transforaminal lumbar interbody fusion procedure (TLIF) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be eligible to participate in this study, the subject must meet all of the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (8 listed)
- Male or female subject that is eligible for both study procedures only at the L4-L5-S1 or L5-S1 levels with bilateral pedicle screws;
- The subject has a diagnosis of one or more of the following conditions at the L4-L5-S1 or L5-S1 levels:
- Adult 18 years of age or older;
- The subject has undergone at least 6 consecutive months of Conservative Care Therapy(ies);
- The subject is able and willing to give written informed consent and to comply with the requirements of this study protocol.
Key exclusion criteria (19 listed)
- Coagulopathy;
- Bowel disease (e.g. Crohn's, ulcerative colitis);
- Severe scoliosis (curves > 60°);
- Sacral agenesis;
- Spondylolisthesis greater than Grade 1 at the L4-L5-S1 levels, or greater than Grade 2 at the L5-S1 level;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy
Time frame: 24 months post-operative
Efficacy: Fusion of the targeted vertebral bodies (L4-L5-S1 or L5-S1) will be assessed individually at 24 months as determined by Central Radiographic Reviewer's (orthopedic surgeon) interpretation of high resolution Computed Tomography (CT) Scan.
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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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.
David Hart, MD principal investigator
University Hospitals Cleveland Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis and Spondylolisthesis, run by Baxano Surgical, Inc. at 11 sites 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 8 inclusion and 19 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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: Slow enrollment). 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?
Efficacy (time frame: 24 months post-operative). 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 9 Jul 2014.