Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-arm post market study of patients to assess fusion in one or multiple continuous levels of the lumbosacral spine (L1-S1) using ViviGen Cellular Bone Matrix. All subjects will be followed out to 24 months for final assessment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Collaborator: DePuy Synthes

Criteria

Inclusion Criteria:

• Subject is scheduled to undergo a single or multilevel posterolateral spinal fusion surgery using ViviGen Cellular Bone matrix

• Subject must be over the age of 18 years old

• Subject has been unresponsive to conservative care for a minimum of 6 months.

• The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Exclusion Criteria:

• Subjects requiring additional bone grafting materials other than local autograft and ViviGen Cellular Bone Matrix will be excluded from this outcomes study.

• Subject has inadequate tissue coverage over the operative site

• Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.

• Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).

• Subject has an active local or systemic infection.

• Subject has a metal sensitivity/foreign body sensitivity.

• Subject is morbidly obese, defined as a body mass index (BMI) greater than 45.

• Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.

• Subject is currently involved in another investigational drug or device study that could confound study data.

• Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.

• Subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating.

• Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.

• Osteoporosis (per the investigator's diagnosis or per a T-score > 2.5 standard deviations below the mean for a young, healthy adult) that may prevent adequate fixation of screws and thus preclude the use of a pedicle screw system.

• Subjects who have a known or suspected allergy to any of the following antibiotics and/or reagents: Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin (HSA);

• Immune compromised subjects

• Known sensitivity to device materials

• Subject is a prisoner.