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

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.

Study Overview

• Status: Withdrawn
• Conditions: Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis
• Intervention / Treatment: Other: ViBone®; Other: Demineralized Bone Matrix; Other: Bone Morphogenetic Protein

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 120 male and female OLIF patients at up to 5 centers in the United States will be enrolled.

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: ViBone®; Viable bone allograft; Other: Demineralized Bone Matrix; Demineralized Bone Matrix; Other: Bone Morphogenetic Protein; 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.	Other: ViBone®; Viable bone allograft; Other: Demineralized Bone Matrix; Demineralized Bone Matrix; Other: Bone Morphogenetic Protein; 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.	Other: ViBone®; Viable bone allograft; Other: Demineralized Bone Matrix; Demineralized Bone Matrix; Other: Bone Morphogenetic Protein; Bone Morphogenetic Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Rates	Fusion rates for each product as evidenced by bridging bone via x-ray radiograph	3, 6, and 12 months
Time to Fusion	Time to fusion for each product as evidenced by bridging bone via x-ray radiograph	3, 6, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications and serious adverse reactions	Number of participants with ViBone®, DBM, or BMP-related complications and serious adverse reactions	Through study completion at 12 months

Collaborators and Investigators

• Sponsor: Aziyo Biologics, Inc.

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 13, 2020

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: DDD; DBM; BMP; OLIF; ViBone
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: CLP-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No