RAMP Study: A Study Comparing Two Lumbar Fusion Procedures (RAMP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01716182 |
Recruitment Status
:
Terminated
(Slow enrollment)
First Posted
: October 29, 2012
Last Update Posted
: July 9, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Spinal Stenosis Spondylolisthesis Degenerative Disc Disease |
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 Type : | Observational |
Estimated Enrollment : | 200 participants |
Time Perspective: | Prospective |
Official Title: | RAMP Study: A Prospective Randomized Study Comparing Two Lumbar Fusion Procedures |
Study Start Date : | June 2012 |
Estimated Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | July 2014 |

Group/Cohort |
---|
transacral lumbar interbody fusion procedure |
transforaminal lumbar interbody fusion procedure (TLIF) |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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);
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716182
United States, California | |
St. Joseph Heritage Healthcare | |
Fullerton, California, United States, 92835 | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Indiana | |
Indiana Spine Group | |
Carmel, Indiana, United States, 46032 | |
United States, Louisiana | |
Bone and Joint Clinic of Baton Rouge | |
Baton Rouge, Louisiana, United States, 70808 | |
LSU Health Sciences Center, Department of Neurosurgery | |
New Orleans, Louisiana, United States, 70112 | |
United States, Massachusetts | |
UMass Medical Center, Department of Neurosurgery | |
Worcester, Massachusetts, United States, 01655 | |
United States, North Carolina | |
Cary Orthopaedic Spine Specialists | |
Cary, North Carolina, United States, 27518 | |
United States, Ohio | |
Mayfield Clinic/University of Cincinnati | |
Cincinnati, Ohio, United States, 45219 | |
University Hospitals Case Medical Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
Brazos Spine | |
College Station, Texas, United States, 77845 | |
United States, Virginia | |
Danville Orthopedic Clinic, Inc. | |
Danville, Virginia, United States, 24541 |
Principal Investigator: | David Hart, MD | University Hospitals Cleveland Medical Center |
Responsible Party: | Baxano Surgical, Inc. |
ClinicalTrials.gov Identifier: | NCT01716182 History of Changes |
Other Study ID Numbers: |
PR-0018 |
First Posted: | October 29, 2012 Key Record Dates |
Last Update Posted: | July 9, 2014 |
Last Verified: | July 2014 |
Additional relevant MeSH terms:
Spinal Stenosis Intervertebral Disc Degeneration Spondylolisthesis Spinal Diseases |
Bone Diseases Musculoskeletal Diseases Spondylolysis Spondylosis |