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

NCT04007094 | Terminated Results DMC

• 1 other identifier: 2018H0253
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Disc Disease; Spinal Stenosis; Spondylosis; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• The Number of Surgical Levels With Successful Lumbar Fusion

  Extent of fusion using the Lenke classification. Radiographic success defined as grade A, partial success grade B and radiographic failure as grades C and D.

  12 months prospective from surgery

Secondary Outcomes (2)

• Number of Participants With or Without Changes in Visual Analog Scale Pain Scores

  12 months prospectively from surgery

• Oswestry Disability Index (ODI) v2.1a

  12 months prospectively from surgery

Study Arms (1)

Study Arm

EXPERIMENTAL

Participants will be entered into the single armed study in which one side of the fusion will be coated with milled local autograft bone and the opposite fusion side will be supplemented with an equal volume of Depuy Synthes ViviGen.

Other: ViviGen Cellular Bone Matrix

Interventions

ViviGen Cellular Bone Matrix OTHER

ViviGen Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 1271.10

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• DePuy Synthes: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43201, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis; Spondylosis; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Limitations and Caveats

Primary Investigator left the university leading to early termination with a small number of subjects analyzed in an interim analysis.

Results Point of Contact

• Title: Shelby Miracle
• Organization: The Ohio State University

shelby.miracle@osumc.edu

614-366-1648

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurological Surgery

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: July 5, 2019
• Study Start: February 12, 2019
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: January 24, 2024
• Results First Posted: January 24, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)