Active — Not RecruitingNot Applicable

Transforaminal Lumbar Interbody Fusion (TLIF)

United States600 participantsStarted 2019-12-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. History of radiating leg or buttock pain, paresthesia, numbness or weakness, or
✓. History of neurogenic claudication.
✓. Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or
✓. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
✓. Recurrent disc herniation

What they're measuring

Overall success at 24 months

Timeframe: 24 months

Fusion success at 24 months

Timeframe: 24 Months

Trial details

NCT IDNCT04073563

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Degenerative Disease of the Lumbosacral Spine trials