Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04007094 |
| Other study ID # |
2018H0253 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 12, 2019 |
| Est. completion date |
January 21, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Lumbar spine fusion rates can vary according to the surgical technique. Although many studies
on spinal fusion have been conducted and reported, the heterogeneity of the study designs and
data handling make it difficult to identify which approach yields the highest fusion rate.
Traditional posterolateral intertransverse fusion (PLF) still remains a good procedure with
acceptable fusion rates for most degenerative conditions. For solid fusion, PLF can be
combined with interbody fusion to circumferentially stabilize the relevant segment, even
though it is unclear whether this improves fusion rates.
A bone graft or bone graft substitute is required to produce the fusion and can be implanted
on its own, in the posterolateral gutters, or contained with an interbody device using either
a posterior or anterior approach. Spinal laminectomy is most often the largest generator of
bone graft product due to the nature of the procedure. The current gold standard is autograft
bone, in which tissue is harvested locally or from the iliac crest and is then placed at the
site. However, local bone graft may be relatively limited and harvesting at the iliac crest
can easily lead to significant morbidity. Complications such as inflammation, infection, and
chronic pain may outlast the pain of the original surgical procedure.
Autograft is the gold standard because it possesses all of the characteristics necessary for
new bone growth-namely, osteoconductivity, osteogenicity, and osteoinductivity. Allograft
tissues are alternatives to autografts and are taken from donors or cadavers, circumventing
some of the shortcomings of autografts by eliminating donor-site morbidity and issues of
limited supply. Osteoconductivity refers to the situation in which the graft supports the
attachment of new osteoblasts and osteoprogenitor cells, providing an interconnected
structure through which new cells can migrate and new vessels can form. Osteogenicity refers
to the situation when the osteoblasts that are at the site of new bone formation are able to
produce minerals to calcify the collagen matrix that forms the substrate for new bone.
Osteoinductivity refers to the ability of a graft to induce nondifferentiated stem cells or
osteoprogenitor cells to differentiate into osteoblasts. Using the 2 basic criteria of a
successful graft, osteoconduction and osteoinduction, investigators have developed several
alternatives, some of which are available for clinical use and others of which are still in
the developmental stage. Many of these alternatives use a variety of materials, including
natural and synthetic polymers, ceramics, and composites, whereas others have incorporated
factor- and cell-based strategies that are used either alone or in combination with other
materials.
