Clinical Research Directory

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1 clinical study listed.

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Transforaminal Lumbar Interbody Fusion

Tundra lists 1 Transforaminal Lumbar Interbody Fusion clinical trial. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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NOT YET RECRUITING

NCT07775729

Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)

This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF). Participants undergoing 1- to 2-level TLIF (L2-S1) are randomized 2:1 to receive ProteiOS or a control graft (local bone with optional cancellous chip augmentation, no ProteiOS). The primary objective is to determine whether the 12-month interbody fusion rate (assessed by CT using the Brantigan-Steffee-Fraser classification) with ProteiOS is non-inferior to control, using a 5-percentage-point non-inferiority margin. Patient-reported outcomes (ODI, VAS, EQ-5D-5L), safety, and healthcare utilization are also assessed. A separate exploratory cohort at one study site will evaluate the same outcomes in participants undergoing anterior lumbar interbody fusion (ALIF) with or without ProteiOS, without formal hypothesis testing.

Gender: All

Ages: 18 Years - 75 Years

Updated: 2026-08-20

Degenerative Disc Disease

Spinal Stenosis Lumbar

Lumbar Spine Fusion