Transforaminal Lumbar Interbody Fusion (TLIF)
Public ClinicalTrials.gov record NCT04073563. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04073563
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 600 participants
Conditions and interventions
Interventions
- Infuse™ Bone Graft (Infuse™) Device
- Intervertebral body fusion device and Medtronic posterior Fixation Systems Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 19, 2019 (Actual)
- Primary completion
- Jul 2027 (Estimated)
- Completion
- Jul 2028 (Estimated)
- Last update posted
- Feb 4, 2026
2019 – 2028
United States locations
- U.S. sites
- 43
- U.S. states
- 20
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of California Irvine | Irvine | California | 92617 | — |
| Memorial Health Services | Laguna Hills | California | 92653 | — |
| Cedars Sinai Spine Center | Los Angeles | California | 90048 | — |
| University of California Davis Medical Center | Sacramento | California | 95816 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Boulder Neurosurgical Associates and Justin Parker Neurological Institute/E. Lee Nelson | Boulder | Colorado | 80303 | — |
| Vail-Summit Orthopaedics and Neurosurgery | Vail | Colorado | 81657 | — |
| Hartford Hospital | Hartford | Connecticut | 06106 | — |
| Advent Health Altamonte Springs | Altamonte Springs | Florida | 32701 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Advent Health Orlando | Orlando | Florida | 32803 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33637 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Goodman Campbell Brain and Spine | Carmel | Indiana | 46032 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| OrthoIndy Northwest Office | Indianapolis | Indiana | 46278 | — |
| University of Iowa Hospitals and Clinic | Iowa City | Iowa | 52242 | — |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Mayo Clinic | Rochester | Minnesota | 55901 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Mayfield Brain and Spine Clinic | Cincinnati | Ohio | 45209 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Penn State-Hershey | Hershey | Pennsylvania | 17033 | — |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | — |
| Semmes Murphey | Memphis | Tennessee | 38120 | — |
| Saint Thomas for Specialty Surgery | Nashville | Tennessee | 37203 | — |
| Tennessee Orthopaedic Alliance | Nashville | Tennessee | 37209 | — |
| DFW Center for Spinal Disorder | Fort Worth | Texas | 76132 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| American Neurospine Institute | Plano | Texas | 75075 | — |
| University of Virginia - Clinical Trial Office | Charlottesville | Virginia | 22904 | — |
| University of Virginia - Health System | Charlottesville | Virginia | 22908 | — |
| Swedish Neuroscience | Seattle | Washington | 98122 | — |
| West Virginia University, 1 Medical Center Drive | Morgantown | West Virginia | 26506 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04073563, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2026 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04073563 live on ClinicalTrials.gov.