Transforaminal Lumbar Interbody Fusion (TLIF) (TLIF)
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- STATUS
- Recruiting
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- End date
- Jun 24, 2025
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- participants needed
- 1017
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- sponsor
- Medtronic Spinal and Biologics
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 1017 subjects will be enrolled and treated. The purpose of the study is to provide safety and effectiveness data of Infuse™ in A Transforaminal Lumbar Interbody Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.
Details
| Condition | Degenerative Disease of the Lumbosacral Spine |
|---|---|
| Treatment | Infuse™ Bone Graft (Infuse™), Capstone™ Spinal System and Medtronic posterior Fixation Systems |
| Clinical Study Identifier | NCT04073563 |
| Sponsor | Medtronic Spinal and Biologics |
| Last Modified on | 24 July 2022 |
Eligibility
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