Spine graft study abandoned after only 6 patients
NCT ID NCT05614284
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to compare a man-made bone graft material called Virtuos against using the patient's own bone for lumbar spine fusion surgery in people with degenerative disc disease. The goal was to see if Virtuos could achieve similar fusion rates at 12 and 24 months. However, the trial was terminated early after enrolling only 6 participants, so no meaningful conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Virtuos Lyograft (bone graft substitute)
- What this could lead to
- If successful, this could show that Virtuos is as effective as using the patient's own bone for spinal fusion, potentially avoiding a second surgical site.
- What could go wrong
- The trial was terminated early with only 6 participants, so results are very limited and not reliable. It is unclear if Virtuos works as well as autograft.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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6 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Virtuos 2. Virtuos 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central CT Neurosurgery & Spine
New Britain, Connecticut, 06051, United States
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Michigan Brain and Spine
Royal Oak, Michigan, 48073, United States
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University of Texas South Western
Dallas, Texas, 75390, United States
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