Comparative Analysis of Virtuos and Autograft in Lumbar Fusion
NCT05614284 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-11-28
Summary
Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.
Conditions
- Degenerative Disc Disease
Interventions
- DEVICE
-
Virtuos
Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.
Sponsors & Collaborators
-
Orthofix Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-14
- Primary Completion
- 2024-05-16
- Completion
- 2024-05-16
- FDA Device
- Yes
Countries
- United States
Study Locations
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