Degenerative Disc DiseaseNCT05614284
Comparative Analysis of Virtuos and Autograft in Lumbar Fusion
A study testing Virtuos in people with Degenerative Disc Disease, run by Orthofix Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Virtuos
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Nov 2022to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 25Show fewer
- 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.
Who cannot join
- 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)
- Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
- Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas South Western
Dallas, Texas, 75390
Central CT Neurosurgery & Spine
New Britain, Connecticut, 06051
Michigan Brain and Spine
Royal Oak, Michigan, 48073
About this study
Official title: A Prospective, Post-Market, Multicenter Comparative Analysis of the Efficacy of Virtuos and Autograft Bone Graft in Lumbar Fusion Surgery
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.
Read the detailed description
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 Virtuos bone graft or autograft/allograft bone graft.
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
- Being tested
- Virtuos
- Keywords
- Lumbar Fusion, Cellular Based Lyograft, TLIF
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VirtuosDevice
Also called Autograft
Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.
| Study group | Role | What they receive |
|---|---|---|
| Virtuos | Experimental | Virtuos +/- Local Bone Receives: Device: Virtuos |
| Autograft | Active comparator | Autograft +/- Allograft Chips Receives: Device: Virtuos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Fusion
Fusion status at Twelve months postoperative
Measured: Twelve months
Secondary outcomes (2)
Clinical Outcomes
Patient Reported Outcomes (PROM): Disability and Pain
Measured: Twelve months
Safety Profile
Incidence of Adverse Events and Serious Adverse Events through Twelve and Twenty-four months.
Measured: Twelve and Twenty-four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start14 Nov 2022
- Primary completion16 May 2024
- Study completion16 May 2024
Why it stopped: Protocol redesign.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 Enrollment: Virtuos vs. Autograft
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614284
- Sponsor's protocol ID
- CP - 2201VLF
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-Market, Multicenter Comparative Analysis of the Efficacy of Virtuos and Autograft Bone Graft in Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT05614284
- Acronym / sponsor ID
- CP - 2201VLF
- Conditions
- Degenerative Disc Disease
- Keywords
- Lumbar Fusion, Cellular Based Lyograft, TLIF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol redesign.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 Virtuos bone graft or autograft/allograft bone graft.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 Enrollment: Virtuos vs. Autograft
| Arm | Type | Receives |
|---|---|---|
| Virtuos | Experimental | Device: VirtuosVirtuos +/- Local Bone |
| Autograft | Active comparator | Device: VirtuosAutograft +/- Allograft Chips |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
Key exclusion criteria (6 listed)
- 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)
- Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VirtuosAlso: AutograftUse of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF. | Device | Autograft, Virtuos |
Primary outcome
Successful Fusion
Time frame: Twelve months
Fusion status at Twelve months postoperative
2 secondary outcomes
Clinical Outcomes
Time frame: Twelve months
Safety Profile
Time frame: Twelve and Twenty-four months
Results and safety
The study was stopped early (reason given: Protocol redesign.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtuos in people with Degenerative Disc Disease, run by Orthofix Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Protocol redesign.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Fusion (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.