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Transforaminal Lumbar Interbody Fusion (TLIF)

NCT04073563 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-02-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States
  • China

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 NCT04073563 on ClinicalTrials.gov