Study Stopped
Lack of enrollment
A Study Evaluating 3-Level OLIF Spine Fusion
A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion
1 other identifier
observational
N/A
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2019
Shorter than P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2020
CompletedJuly 20, 2023
July 1, 2023
7 months
March 27, 2019
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Graft Mineralization/Fusion
Degree of graft mineralization/fusion for each product via CT scan
12 months
Graft Mineralization/Fusion
Degree of graft mineralization/fusion for each product via CT scan
6 months
Secondary Outcomes (2)
Fusion Rates
3, 6, and 12 months
Time to Fusion
3, 6, and 12 months
Other Outcomes (1)
Complications and serious adverse reactions
Through study completion at 12 months
Study Arms (3)
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.
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.
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.
Interventions
Demineralized Bone Matrix
Bone Morphogenetic Protein
Eligibility Criteria
Up to 120 male and female OLIF patients at up to 5 centers in the United States will be enrolled.
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elutia Inc.lead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2019
First Posted
March 29, 2019
Study Start
July 1, 2019
Primary Completion
February 7, 2020
Study Completion
February 13, 2020
Last Updated
July 20, 2023
Record last verified: 2023-07