SpondylolisthesisNCT03896347
A Study Evaluating 3-Level OLIF Spine Fusion
An observational study of Spondylolisthesis and Retrolisthesis, run by Elutia Inc..
Trial summary
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic protein (BMP). One product will be used on each level. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondylolisthesis, Retrolisthesis, Degenerative Disc Disease
- What is being tested?
- ViBone®, Demineralized Bone Matrix and Bone Morphogenetic Protein
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 13 Feb 2020
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 120 male and female OLIF patients at up to 5 centers in the United States will be enrolled.
Who may be able to join
- Male or female, 18-80 years of age
- Patient must have degenerative disc disease, defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, affecting three contiguous levels between L2 and S1. Affected levels may also have up to Grade 1 spondylolisthesis or retrolisthesis
- Patient must have at least 6 months on non-operative treatment prior to study enrollment
- Patient signed Informed Consent Form
- Patient signed HIPAA Authorization (may be part of the ICF)
- Appropriate candidate for OLIF surgery using ViBone®, DBM, and BMP)
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- Patient will adhere to the scheduled follow-up visits and requirements of the protocol
- Routine patient exams include pre-operative, operative, and three post-operative visits (3, 6, and 12 months post-surgery)
- CT scan of surgical site 6 and 12 months post-surgery
Who cannot join
- Long-term, chronic use of medications that are known to inhibit fusion, bone metabolism, or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
- Treatment with radiotherapy
- Patients who have who have had surgery for primary tumors or metastatic malignant tumors of the lumbar or sacral spine
- 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
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- Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density test 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.
- Morbid obesity as defined by a body mass index (BMI) of 40 or greater
- Patients with an allergy to titanium or titanium alloy
- Patients who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)
- Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.
- Patients with a known hypersensitivity to recombinant Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation of the BMP
About this study
Official title: A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic protein (BMP). One product will be used on each level. Subjects will be followed for 12 months following surgery to assess degree of mineralization via computed tomography (CT) scan at 6 and 12 months, mean time to fusion, and maturation of fusion mass postoperatively via x-ray radiograph.
Read the detailed description
Up to 120 patients undergoing three-level OLIF using ViBone, DBM, and BMP each on separate levels will be enrolled.
Implantation of ViBone, DBM, and BMP will be randomized between the three levels.
Subjects will be followed for a total of 12 months. Data and x-ray radiographs will be collected according to standard of care, including baseline, 3, 6, and 12 months post-surgery. Additionally, a CT scan will be required at 6 and 12 months.
- Conditions
- Spondylolisthesis, Retrolisthesis, Degenerative Disc Disease
- Being tested
- ViBone®, Demineralized Bone Matrix, Bone Morphogenetic Protein
- Keywords
- OLIF, ViBone, DBM, BMP, DDD
- Medical subject headings
- Spondylolisthesis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViBone®Other
Viable bone allograft
Demineralized Bone MatrixOther
Demineralized Bone Matrix
Bone Morphogenetic ProteinOther
Bone Morphogenetic Protein
| Study group | Role | What they receive |
|---|---|---|
| ViBone® | One product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels. Receives: Other: ViBone®; Other: Demineralized Bone Matrix; Other: Bone Morphogenetic Protein | |
| Demineralized Bone Matrix | One product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels. Receives: Other: ViBone®; Other: Demineralized Bone Matrix; Other: Bone Morphogenetic Protein | |
| Bone Morphogenetic Protein | One product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels. Receives: Other: ViBone®; Other: Demineralized Bone Matrix; Other: Bone Morphogenetic Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Mineralization/Fusion
Degree of graft mineralization/fusion for each product via CT scan
Measured: 12 months
Graft Mineralization/Fusion
Degree of graft mineralization/fusion for each product via CT scan
Measured: 6 months
Secondary outcomes (2)
Fusion Rates
Fusion rates for each product as evidenced by bridging bone via x-ray radiograph
Measured: 3, 6, and 12 months
Time to Fusion
Time to fusion for each product as evidenced by bridging bone via x-ray radiograph
Measured: 3, 6, 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 posted29 Mar 2019
- Study start1 Jul 2019
- Primary completion7 Feb 2020
- Study completion13 Feb 2020
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolisthesisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT03896347
- Sponsor's protocol ID
- CLP-0003
- Status last verified
- Jul 2023
- First submitted
- 27 Mar 2019
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT03896347
- Acronym / sponsor ID
- CLP-0003
- Conditions
- Spondylolisthesis, Retrolisthesis, Degenerative Disc Disease
- Keywords
- OLIF, ViBone, DBM, BMP, DDD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 29 Mar 2019 (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.
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic protein (BMP). One product will be used on each level. Subjects will be followed for 12 months following surgery to assess degree of mineralization via computed tomography (CT) scan at 6 and 12 months, mean time to fusion, and maturation of fusion mass postoperatively via x-ray radiograph.
Detailed description
Up to 120 patients undergoing three-level OLIF using ViBone, DBM, and BMP each on separate levels will be enrolled.
Implantation of ViBone, DBM, and BMP will be randomized between the three levels.
Subjects will be followed for a total of 12 months. Data and x-ray radiographs will be collected according to standard of care, including baseline, 3, 6, and 12 months post-surgery. Additionally, a CT scan will be required at 6 and 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ViBone® | – | Other: ViBone®, Other: Demineralized Bone Matrix, Other: Bone Morphogenetic ProteinOne product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels. |
| Demineralized Bone Matrix | – | Other: ViBone®, Other: Demineralized Bone Matrix, Other: Bone Morphogenetic ProteinOne product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels. |
| Bone Morphogenetic Protein | – | Other: ViBone®, Other: Demineralized Bone Matrix, Other: Bone Morphogenetic ProteinOne product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 120 male and female OLIF patients at up to 5 centers in the United States will be enrolled.
Key inclusion criteria (9 listed)
- Male or female, 18-80 years of age
- Patient must have degenerative disc disease, defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, affecting three contiguous levels between L2 and S1. Affected levels may also have up to Grade 1 spondylolisthesis or retrolisthesis
- Patient must have at least 6 months on non-operative treatment prior to study enrollment
- Patient signed Informed Consent Form
- Patient signed HIPAA Authorization (may be part of the ICF)
Key exclusion criteria (13 listed)
- Long-term, chronic use of medications that are known to inhibit fusion, bone metabolism, or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
- Treatment with radiotherapy
- Patients who have who have had surgery for primary tumors or metastatic malignant tumors of the lumbar or sacral spine
- 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.
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 |
|---|---|---|
| ViBone®Viable bone allograft | Other | Bone Morphogenetic Protein, Demineralized Bone Matrix, ViBone® |
| Demineralized Bone MatrixDemineralized Bone Matrix | Other | Bone Morphogenetic Protein, Demineralized Bone Matrix, ViBone® |
| Bone Morphogenetic ProteinBone Morphogenetic Protein | Other | Bone Morphogenetic Protein, Demineralized Bone Matrix, ViBone® |
Primary outcome
Graft Mineralization/Fusion
Time frame: 12 months
Degree of graft mineralization/fusion for each product via CT scan
Graft Mineralization/Fusion
Time frame: 6 months
Degree of graft mineralization/fusion for each product via CT scan
2 secondary outcomes
Fusion Rates
Time frame: 3, 6, and 12 months
Time to Fusion
Time frame: 3, 6, and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Sponsor websiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylolisthesis and Retrolisthesis, run by Elutia Inc..
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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Graft Mineralization/Fusion (time frame: 12 months). The study lists 2 primary outcomes in all. 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 20 Jul 2023.