ViBone in Cervical and Lumbar Spine Fusion

Study Purpose

Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male or female, 18-80 years of age - For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7 - For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1 - Patient signed Consent Form with HIPAA Authorization - Appropriate candidate for surgery - Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery).

Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).

Exclusion Criteria:

- Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.) - Treatment with radiotherapy - Acute or chronic systemic or localized spinal infections - Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine - Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for - TLIF, PLIF, ALIF, or LLIF patients) 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 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.

- Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03425682
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aziyo Biologics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus, Degenerative Disc Disease

Additional Details

This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for up to 50 subjects undergoing ACDF surgery and up to 50 subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.

Arms & Interventions

Arms

: Cervical Fusion - ACDF

Up to 50 patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled.

: Lumbar Interbody Fusion

Up to 50 patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled.

Interventions

Other: - ViBone

Viable Bone Allograft

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Spine Institute of San Diego, San Diego, California

Status

Recruiting

Address

Spine Institute of San Diego

San Diego, California, 92120

Site Contact

Josephine Turner

[email protected]

619-229-5353

Connecticut Neck & Back Specialists, LLC, Danbury, Connecticut

Status