Comparative Analysis of Virtuous and Autograft in Lumbar Fusion

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

-
Inclusion criteria:
1.

At least 18 years of age at the time of surgery. 2. Undergoing lumbar spine fusion surgery with one of the following bone grafting options: 1. Virtuous. 2. Virtuous with Autograft (local bone) 3. Autograft. 4. Autograft + allograft (cancellous bone chips) 3. 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: 1. Instability as defined by >3mm translation or >5 degrees angulation. 2. Osteophyte formation of facet joints or vertebral endplates. 3. Decreased disc height, on average by >2mm, but dependent upon the spinal level. 4. Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule. 5. Herniated nucleus pulposus. 6. Facet joint degeneration/changes; and/or. 7. Vacuum phenomenon. 4. Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena: 1. Radiculopathy. 2. Sensory deficit. 3. Motor weakness. 4. Reflex changes. 5. Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1). 6. The number of levels decompressed must equal the number of levels fused. 7. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery. 8. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study. 9. Subject must be willing and able to sign an informed consent document. 10. 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.

Exclusion Criteria:

Exclusion criteria:

1. Subject is under 18 years of age (<18) at the time of consent. 2. Subject has had prior lumbar spine fusion surgery at any level. 3. Subject has greater than grade 1 spondylolisthesis of the lumbar spine. 4. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted) 5. Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis. 6. Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05614284
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Orthofix Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Degenerative Disc Disease

Additional Details

The purpose of this study is to compare clinical and radiographic outcomes in patients undergoing transforaminal lumbar interbody fusion (minimally invasive or open) with either Virtuous bone graft or autograft/allograft bone graft. 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.

Arms & Interventions

Arms

Experimental: Virtuous

Virtuous +/- Local Bone

Active Comparator: Autograft

Autograft +/- Allograft Chips

Interventions

Device: - Virtuos

Use of autograft or Virtuous Lyograft as an adjunct to spinal fusion in TLIF.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Michigan Brain and Spine, Royal Oak, Michigan

Status

Recruiting

Address

Michigan Brain and Spine

Royal Oak, Michigan, 48073

Site Contact

Ramiro De La Torre, MD

[email protected]

248-898-5000

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