Clinical Trial

Transforaminal Lumbar Interbody Fusion (TLIF)

Study acronym: TLIF
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 51 amendments
This ClinicalTrials.gov record has been amended 51 times since 2019-08-27; most recent amendment 2026-02-02.
Status change: Recruiting → Active, Not Recruiting 2025-07-28
Status change: Not Yet Recruiting → Recruiting 2020-01-07
Trial Details
NCT Number NCT04073563
Lead Sponsor Medtronic Spinal and Biologics
Conditions Degenerative Disease of the Lumbosacral Spine
Enrollment 600 participants
Start Date 2019-12-19
Primary Completion 2027-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-04