A Study Evaluating 3-Level OLIF Spine Fusion
- Conditions
- RetrolisthesisDegenerative Disc DiseaseSpondylolisthesis
- Interventions
- Other: ViBone®Other: Demineralized Bone MatrixOther: Bone Morphogenetic Protein
- Registration Number
- NCT03896347
- Lead Sponsor
- Aziyo Biologics, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ViBone® 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. ViBone® 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 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. 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. ViBone® 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. 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. Demineralized Bone Matrix 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 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. Demineralized Bone Matrix 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.
- Primary Outcome Measures
Name Time Method Graft Mineralization/Fusion 6 months Degree of graft mineralization/fusion for each product via CT scan
- Secondary Outcome Measures
Name Time Method Fusion Rates 3, 6, and 12 months Fusion rates for each product as evidenced by bridging bone via x-ray radiograph
Time to Fusion 3, 6, and 12 months Time to fusion for each product as evidenced by bridging bone via x-ray radiograph