Clinical trial NCT03896347: A Study Evaluating 3-Level OLIF Spine Fusion
Official title: A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spondylolisthesis
Retrolisthesis
Degenerative Disc Disease
Keywords: OLIF
ViBone
DBM
BMP
DDD
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft Mineralization/Fusion
timeFrame: 12 months
measure: Graft Mineralization/Fusion
timeFrame: 6 months
Secondary outcomes:
measure: Fusion Rates
timeFrame: 3, 6, and 12 months
measure: Time to Fusion
timeFrame: 3, 6, and 12 months
Other outcomes:
measure: Complications and serious adverse reactions
timeFrame: Through study completion at 12 months
Locations:
Study officials:
References: