RAMP Study: A Study Comparing Two Lumbar Fusion Procedures

NCT01716182 | Terminated

• 1 other identifier: PR-0018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 11

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.

Conditions

Spinal Stenosis; Spondylolisthesis; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months post-operative

Study Arms (2)

transacral lumbar interbody fusion procedure

transforaminal lumbar interbody fusion procedure (TLIF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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;
• 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;

Sponsors & Collaborators

• Baxano Surgical, Inc.: lead

Study Sites (11)

St. Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

LSU Health Sciences Center, Department of Neurosurgery

New Orleans, Louisiana, 70112, United States

Location

UMass Medical Center, Department of Neurosurgery

Worcester, Massachusetts, 01655, United States

Location

Cary Orthopaedic Spine Specialists

Cary, North Carolina, 27518, United States

Location

Mayfield Clinic/University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Brazos Spine

College Station, Texas, 77845, United States

Location

Danville Orthopedic Clinic, Inc.

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• David Hart, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 29, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

US (11)