NCT04073563

Transforaminal Lumbar Interbody Fusion (TLIF)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Disease of the Lumbosacral Spine

Interventions

Type	Name	Description
DEVICE	Infuse™ Bone Graft (Infuse™)	(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
DEVICE	Intervertebral body fusion device and Medtronic posterior Fixation Systems	Adaptix™Interbody System, Capstone™ Spinal System, Catalyft™ PL Interbody System

Timeline

• Start date: 2019-12-19
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2019-08-29
• Last updated: 2026-02-04

Locations

46 sites across 2 countries: United States, China

Regulatory

• FDA-regulated device study