SpondylosisNCT03425682
ViBone in Cervical and Lumbar Spine Fusion
An observational study of Spondylosis and Cervical Spondylosis, run by Elutia Inc. at 4 sites in United States.
Trial summary
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondylosis, Cervical Spondylosis, Spondylolisthesis
- What is being tested?
- ViBone
- How many people
- 118 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2018to 30 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients, 18-80 years of age undergoing 1-3 level anterior cervical discectomy fusion (ACDF), or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
Who may be able to join
- Male or female, 18-80 years of age
- For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
- For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
- Patient signed Consent Form with HIPAA Authorization
- Appropriate candidate for surgery
- Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).
Who cannot join
- Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
- Treatment with radiotherapy
- Acute or chronic systemic or localized spinal infections
- Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
- Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
- TLIF, PLIF, ALIF, or LLIF patients) spine
Show all 12Show fewer
- Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study
- Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma are eligible.
- Inability to provide informed consent
- Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density score of ≤-2.5).
- Other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
- Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anne Arundel Medical Group
Annapolis, Maryland, 21401
Orthopedic Specialists of Austin
Austin, Texas, 78751
Connecticut Neck & Back Specialists, LLC
Danbury, Connecticut, 06810
Spine Institute of San Diego
San Diego, California, 92120
About this study
Official title: A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
Read the detailed description
This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for subjects undergoing ACDF surgery and subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.
- Conditions
- Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus, Degenerative Disc Disease
- Being tested
- ViBone
- Keywords
- Anterior Cervical Discectomy and Fusion (ACDF), Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Interbody Fusion (PLIF)
- Medical subject headings
- Spondylosis, Spondylolisthesis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViBoneOther
Viable Bone Allograft
| Study group | Role | What they receive |
|---|---|---|
| Cervical Fusion - ACDF | Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. Receives: Other: ViBone | |
| Lumbar Interbody Fusion | Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. Receives: Other: ViBone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rates Per Level Using the Bridwell Interbody Grading Scale
Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone.
Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present.
Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion absent with collapse/resorption of graft.
Measured: 12 months
Secondary outcomes (3)
Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months
Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion (0-100) 0 is no disability and 100 is bed-bound.
Measured: Baseline and 12 months
Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months
Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion Scale of 0 - 100, where 0 is no problems at all and 100 is severely affected.
Measured: Baseline and 12 months
Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months
Visual Analog Scale (VAS) for pain improvement relative to baseline (Pain scale from 0-10, with 0 being No Pain and 10 being Worst Pain)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start14 May 2018
- Primary completion15 Jan 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondylosisStudies 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425682
- Sponsor's protocol ID
- CLP-0001
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2018
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim PD, Raiszadeh R, Bomback DA, Kramer DL, Moghimi M. 12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery. J Orthop Surg Res. 2023 Mar 25;18(1):239. doi: 10.1186/s13018-023-03686-9.
PubMed 36964582
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion
- ClinicalTrials.gov ID
- NCT03425682
- Acronym / sponsor ID
- CLP-0001
- Conditions
- Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus, Degenerative Disc Disease
- Keywords
- Anterior Cervical Discectomy and Fusion (ACDF), Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Interbody Fusion (PLIF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
Detailed description
This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for subjects undergoing ACDF surgery and subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Fusion - ACDF | – | Other: ViBonePatients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled. |
| Lumbar Interbody Fusion | – | Other: ViBonePatients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients, 18-80 years of age undergoing 1-3 level anterior cervical discectomy fusion (ACDF), or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
Key inclusion criteria (6 listed)
- Male or female, 18-80 years of age
- For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
- For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
- Patient signed Consent Form with HIPAA Authorization
- Appropriate candidate for surgery
Key exclusion criteria (12 listed)
- Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
- Treatment with radiotherapy
- Acute or chronic systemic or localized spinal infections
- Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
- Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
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 |
|---|---|---|
| ViBoneViable Bone Allograft | Other | Cervical Fusion - ACDF, Lumbar Interbody Fusion |
Primary outcome
Fusion Rates Per Level Using the Bridwell Interbody Grading Scale
Time frame: 12 months
Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone. Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present. Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion absent with collapse/resorption of graft.
3 secondary outcomes
Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months
Time frame: Baseline and 12 months
Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months
Time frame: Baseline and 12 months
Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36964582Kim PD, Raiszadeh R, Bomback DA, Kramer DL, Moghimi M. 12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery. J Orthop Surg Res. 2023 Mar 25;18(1):239. doi: 10.1186/s13018-023-03686-9.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylosis and Cervical Spondylosis, run by Elutia Inc. at 4 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rates Per Level Using the Bridwell Interbody Grading Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425682, which also lists 1 linked publication.
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 4 Mar 2025.