TerminatedNCT01716182RAMPUpdated Jul 9, 2014

RAMP Study: A Study Comparing Two Lumbar Fusion Procedures

An observational study in Spinal Stenosis, Spondylolisthesis and Degenerative Disc Disease, sponsored by Baxano Surgical, Inc.. Terminated at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-09.

Sponsored by Baxano Surgical, Inc. · Observational

Why this study was terminated

Slow enrollment

Study type: Observational
Time perspective: Prospective
Enrollment: 200
Ages: 18 Years and older
Sex: All

Study 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). 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.

Conditions studied

Spinal Stenosis
Spondylolisthesis
Degenerative Disc Disease

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In context

Spinal Stenosis

458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 154 observational studies indexed under Spinal Stenosis.

Browse Spinal Stenosis studies →

Lead sponsor

Baxano Surgical, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and to comply with the requirements of this study protocol.

Exclusion criteria

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 , 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 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Time perspective: Prospective
Enrollment: 200 participants (estimated)

Groups and cohorts

transacral lumbar interbody fusion procedure
transforaminal lumbar interbody fusion procedure (TLIF)

What researchers measure

Primary outcomes

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.
Time frame: 24 months post-operative

Study locations

11 sites

St. Joseph Heritage Healthcare
Fullerton, California 92835, United States
Cedars-Sinai Medical Center
Los Angeles, California 90048, United States
Indiana Spine Group
Carmel, Indiana 46032, United States
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana 70808, United States
LSU Health Sciences Center, Department of Neurosurgery
New Orleans, Louisiana 70112, United States
UMass Medical Center, Department of Neurosurgery
Worcester, Massachusetts 01655, United States
Cary Orthopaedic Spine Specialists
Cary, North Carolina 27518, United States
Mayfield Clinic/University of Cincinnati
Cincinnati, Ohio 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio 44106, United States
Brazos Spine
College Station, Texas 77845, United States
Danville Orthopedic Clinic, Inc.
Danville, Virginia 24541, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2012, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 24, 2012
First posted: Oct 29, 2012
Start: Jun 2012
Primary completionEst.: Jul 2014
CompletionEst.: Jul 2014
Last update: Jul 9, 2014

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01716182
Lead sponsor: Baxano Surgical, Inc.
Responsible party: Sponsor
First posted: Oct 29, 2012
Start date: Jun 2012
Primary completion: Jul 2014 (estimated)
Completion: Jul 2014 (estimated)
Last update: Jul 9, 2014

Study contacts

David Hart, MD

principal investigator · University Hospitals Cleveland Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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