Transforaminal Lumbar Interbody Fusion (TLIF) (NCT04073563)
Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine
🩺 Plain-English Summary (8th-Grade Level)
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be determined at 24 months postoperatively. Overall a maximum of 600 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (46 Sites)
Showing the first 25 of 46 sites.
- Mayo Clinic — Phoenix, Arizona
- University of Arizona — Tucson, Arizona
- University of California Irvine — Irvine, California
- Memorial Health Services — Laguna Hills, California
- Cedars Sinai Spine Center — Los Angeles, California
- University of California Davis Medical Center — Sacramento, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson — Boulder, Colorado
- Vail-Summit Orthopaedics and Neurosurgery — Vail, Colorado
- Hartford Hospital — Hartford, Connecticut
- Advent Health Altamonte Springs — Altamonte Springs, Florida
- Mayo Clinic — Jacksonville, Florida
- Advent Health Orlando — Orlando, Florida
- Orlando Health — Orlando, Florida
- Foundation for Orthopaedic Research and Education — Tampa, Florida
- Rush University Medical Center — Chicago, Illinois
- Goodman Campbell Brain and Spine — Carmel, Indiana
- Indiana Spine Group — Carmel, Indiana
- OrthoIndy Northwest Office — Indianapolis, Indiana
- University of Iowa Hospitals and Clinic — Iowa City, Iowa
- Lahey Hospital & Medical Center — Burlington, Massachusetts
- Baystate Medical Center — Springfield, Massachusetts
- University of Michigan Health System — Ann Arbor, Michigan
- William Beaumont Hospital — Royal Oak, Michigan
- Mayo Clinic — Rochester, Minnesota
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Degenerative Disease of the Lumbosacral Spine clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.