Comparative Analysis of Virtuos and Autograft in Lumbar Fusion (NCT05614284) | Clinical Trial Compass
TerminatedNot Applicable
Comparative Analysis of Virtuos and Autograft in Lumbar Fusion
Stopped: Protocol redesign.
United States6 participantsStarted 2022-11-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 18 years of age at the time of surgery
✓. Undergoing lumbar spine fusion surgery with one of the following bone grafting options:
✓. Virtuos
✓. Virtuos with Autograft (local bone)
✓. Autograft
✓. Autograft + allograft (cancellous bone chips)
✓. Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:
✓. Instability as defined by \>3mm translation or \>5 degrees angulation
Exclusion criteria
✕. Subject is under 18 years of age (\<18) at the time of consent
✕. Subject has had prior lumbar spine fusion surgery at any level
✕. Subject has greater than grade 1 spondylolisthesis of the lumbar spine
✕. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)