A Prospective, Post-Market, Multicenter Comparative Analysis of the Efficacy of Virtuous and Autograft Bone Graft in Lumbar Fusion Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuous 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ At least 18 years of age at the time of surgery

• Undergoing lumbar spine fusion surgery with one of the following bone grafting options:

∙ Virtuous

‣ Virtuous 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

‣ Osteophyte formation of facet joints or vertebral endplates

‣ Decreased disc height, on average by \>2mm, but dependent upon the spinal level

‣ Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule

‣ Herniated nucleus pulposus

‣ Facet joint degeneration/changes; and/or

‣ Vacuum phenomenon

• Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena:

∙ Radiculopathy

‣ Sensory deficit

‣ Motor weakness

‣ Reflex changes

• Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1).

• The number of levels decompressed must equal the number of levels fused.

• Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery.

• Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study

• Subject must be willing and able to sign an informed consent document.

⁃ Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.

Locations
United States
Michigan
Michigan Brain and Spine
RECRUITING
Royal Oak
Contact Information
Primary
Christopher Gunter, MPH
chrisgunter@orthofix.com
9015962386
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2025-12-02
Participants
Target number of participants: 75
Treatments
Experimental: Virtuous
Virtuous +/- Local Bone
Active_comparator: Autograft
Autograft +/- Allograft Chips
Sponsors
Leads: Orthofix Inc.

This content was sourced from clinicaltrials.gov