RAMP Study: A Study Comparing Two Lumbar Fusion Procedures (RAMP)

Study Description

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Brief 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.

Condition or disease
Spinal Stenosis; Spondylolisthesis; Degenerative Disc Disease

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

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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

Groups and Cohorts

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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	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.

Criteria

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Baxano Surgical, Inc.

Investigators

Principal Investigator:	David Hart, MD	University Hospitals Cleveland Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Baxano Surgical, Inc.
ClinicalTrials.gov Identifier:	NCT01716182 History of Changes
Other Study ID Numbers:	PR-0018
First Posted:	October 29, 2012
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