Biomet Spine has announced that it has enrolled the first patient in a randomised clinical trial evaluating Cellentra viable cell bone matrix compared to autograft, considered the standard of care, in patients undergoing two and three level anterior cervical spine fusion. The trial is designed to assess fusion rates and function to determine whether Cellentra viable cell bone matrix can alleviate the need to harvest autograft from the patient’s own hip. Such harvest is a secondary surgery that can result in complications including infection, wound healing and chronic pain at the harvest site.
This randomised, controlled, multisite study aims to enroll approximately 210 patients. Patients randomised to receive Cellentra viable cell bone matrix will be treated with Cellentra viable cell bone matrix placed within bulk bone allograft with Biomet Spine’s MaxAn anterior cervical plate system. Patients in the control autograft group will be treated the same way, except autograft taken from the iliac crest will be placed in the bulk bone allograft. All patients will be evaluated at three, six, 12 and 24 months for function, pain and radiographic success, with computed tomography radiography used at 12 months to independently determine whether fusion has occurred.
The first patient has been enrolled under principal investigatorGary Ghiselli, atDenver Spine Surgeons in Denver, Colorado, USA.
Ghiselli says, “We are excited to be participating in this study to investigate how Cellentra viable cell bone matrix compares to autograft in multiple segment cervical fusion. Autograft remains the gold-standard in most orthopaedic surgery; however, alleviating the need to access patients’ hips to harvest it would represent an advance in care. With this first enrolment, we are on our way toward determining if such an advance can be made by this particular viable bone cell matrix.”
Cellentra viable bone cell matrix is a human tissue allograft consisting of a cancellous bone matrix that contains naturally occurring viable cells, combined with demineralised cortical bone matrix. Cellentra viable cell bone matrix provides three components of the bone healing triad through its osteoinductive, osteogenic and osteoconductive properties. Specifically, Cellentra viable cell bone matrix provides naturally-occurring viable cells that can become bone forming cells, growth factors that are known to be involved in the bone healing process, and a trabecular cancellous scaffold upon which bone forming cells can migrate and remodel. Cellentra viable cell bone matrix has also shown an excellent safety profile as it is immuno-protective and has been designed to provide superior handling through consistent graft-packing capabilities which may facilitate controlled graft placement.