RAMP Study: A Study Comparing Two Lumbar Fusion Procedures

Stopped early

Conditions studied: Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT01716182

Run by

Baxano Surgical, Inc.

People needed

200

Starts

2012-06-01

Expected to finish

2014-07-01

Last updated by the study team

2014-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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