"To alleviate pain and neurological deficits resulting from nerve
compression caused by degenerative disc disease, the most common
recourse is surgical decompression through an anterior approach followed
by the insertion of a structural interbody spacer filled with bone graft
material," said Dr.
This prospective, multi-center, clinical study was designed to evaluate the effectiveness of Trinity Evolution, a viable cellular bone allograft in patients undergoing a single level fusion at the vertebral locations between C3/C4 and C6/C7. Trinity Evolution was placed within and around each Orthofix PEEK interbody spacer to promote bone growth.
"We are committed to investing in meaningful clinical research to aid
physicians in their treatment decisions," said
The primary endpoint was radiographic fusion status based on independent review of CT scans and radiographic review of angular motion. The criteria for fusion was the presence of bridging bone across the adjacent endplates as seen on thin cut CT scans in addition to angular motion from flexion/extension X-rays.
In addition, secondary endpoints were measured including function as assessed by the Neck Disability Index and neck and arm pain as assessed by individual Visual Analog Scales (VAS). Neck function and neck/arm pain were found to significantly improve at both 6 and 12 months. There were no serious adverse events attributable to Trinity Evolution as determined by an independent consultant.
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"MTF is committed to research to ensure innovative clinical options
exist for all patients," said
Trinity Evolution is the predecessor of Trinity ELITE®, a moldable bone graft material that enables physicians to easily control the placement of tissue during procedures. To date there have been more than 150,000 procedures using Trinity Evolution and Trinity ELITE.
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