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RAMP Study: A Study Comparing Two Lumbar Fusion Procedures

NCT01716182 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2014-07-09

No results posted yet for this 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.

Conditions

  • Spinal Stenosis
  • Spondylolisthesis
  • Degenerative Disc Disease

Sponsors & Collaborators

  • Baxano Surgical, Inc.

    lead INDUSTRY

Principal Investigators

  • David Hart, MD · University Hospitals Cleveland Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716182 on ClinicalTrials.gov