Degenerative Disc DiseaseNCT06686017
Virtuos Bone Graft in Lumbar Fusion
An observational study of Degenerative Disc Disease, run by Orthofix Inc. at 9 sites in United States.
Trial summary
A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- How many people
- 150 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Jun 2025to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population are patients with degenerative disc disease of the lumbar spine at one or two levels who are considered to be candidates for spinal fusion surgery by their attending physician/surgeon.
Who may be able to join
- Subject must be 18 years of age (≥ 18 years) or older at the time of consent.
- Subject must undergo lumbar interbody fusion study at 1-2 contiguous levels.
- Virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips.
- 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 protocol.-
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 has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
UT Southwestern Medical Center
Frisco, Texas, 75033
Northern Rockies Orthopaedics
Missoula, Montana, 59804
OrthoSC
Myrtle Beach, South Carolina, 29579
Lowcountry Orthopaedics and Sports Medicine
North Charleston, South Carolina, 29406
South Carolina Sports Medicine
North Charleston, South Carolina, 29406
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Tuckahoe Orthopaedics
Richmond, Virginia, 23226
South Bend Orthopaedics
South Bend, Indiana, 46635
Michigan Orthopedic Surgeons
Southfield, Michigan, 48033
About this study
Official title: A Prospective Post-Market Historically Controlled Open-Label Study to Assess the Efficacy of Virtuos in Lumbar Fusion
A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels
Read the detailed description
Single arm prospectively enrolled observational study of subjects who undergo lumbar spinal fusion at one or two levels with an anterior or lateral surgical approach using a cellular based allograft (Virtuos) as the bone graft There is no experimental intervention for this study. Subjects will be treated per standard of care by their attending physician/surgeon. The primary endpoint in this study is fusion success at 12 months. as determined by the attending physician/surgeon using CT as the imaging modality. The fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an anterior or lateral approach using a cellular based allograft (Trinity Elite).
- Conditions
- Degenerative Disc Disease
- Keywords
- Lumbar spinal fusion, Cellular based allograft, Anterior lumbar interbody fusion (ALIF), Lateral lumbar interbody fusion (LLIF), Virtuos
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with one or two level degenerative disc disease of the lumbar spine | There are no investigational interventions. Subjects will undergo a one or two level spinal fusion procedure per the attending physician/surgeon standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Fusion of the spinal motion segments
Measured: 12-months
Secondary outcomes (2)
Disability (ODI)
The ODI will be used to assess disability if the patient reported outcomes are routinely collected at participating centers.
Measured: 12 months
Pain (NPRS)
A pain rating scale (VAS or NRS) will be used to assess pain levels at baseline and follow-up visits, if pain assessment is routinely collected as standard of care at participating sites. 0 will indicate no pain and 10 will indicate the highest amount of pain possible.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start5 Jun 2025
- Primary completionJan 2029 (estimated)
- Study completionApr 2029 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686017
- Sponsor's protocol ID
- CIP-VBG-24
- Status last verified
- Nov 2025
- First submitted
- 7 Nov 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Historically Controlled Open-Label Study to Assess the Efficacy of Virtuos in Lumbar Fusion
- ClinicalTrials.gov ID
- NCT06686017
- Acronym / sponsor ID
- CIP-VBG-24
- Conditions
- Degenerative Disc Disease
- Keywords
- Lumbar spinal fusion, Cellular based allograft, Anterior lumbar interbody fusion (ALIF), Lateral lumbar interbody fusion (LLIF), Virtuos
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 13 Nov 2024 (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.
A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels
Detailed description
Single arm prospectively enrolled observational study of subjects who undergo lumbar spinal fusion at one or two levels with an anterior or lateral surgical approach using a cellular based allograft (Virtuos) as the bone graft There is no experimental intervention for this study. Subjects will be treated per standard of care by their attending physician/surgeon. The primary endpoint in this study is fusion success at 12 months. as determined by the attending physician/surgeon using CT as the imaging modality. The fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an anterior or lateral approach using a cellular based allograft (Trinity Elite).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with one or two level degenerative disc disease of the lumbar spine | – | –There are no investigational interventions. Subjects will undergo a one or two level spinal fusion procedure per the attending physician/surgeon standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are patients with degenerative disc disease of the lumbar spine at one or two levels who are considered to be candidates for spinal fusion surgery by their attending physician/surgeon.
Key inclusion criteria (5 listed)
- Subject must be 18 years of age (≥ 18 years) or older at the time of consent.
- Subject must undergo lumbar interbody fusion study at 1-2 contiguous levels.
- Virtuos must be the primary bone graft (≥ 50% of the total graft volume) and may be augmented with autograft or cortical or cancellous bone chips.
- 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 protocol.-
Key exclusion criteria (4 listed)
- Subject is under 18 years of age (<18) at the time of consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fusion
Time frame: 12-months
Fusion of the spinal motion segments
2 secondary outcomes
Disability (ODI)
Time frame: 12 months
Pain (NPRS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Orthofix Inc. at 9 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 5 inclusion and 4 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: enrolling by invitation, 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 9 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?
This study is still under way. Results are not available in the source record yet.
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?
Fusion (time frame: 12-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.