Continuously Load-Sharing Elastically Deformable Spinal Fusion Implant

DESCRIPTION provided by applicant ReVivo Medical LLC has developed the next generation of spinal fusion implants to help surgeons and hospitals achieve the goals of the Affordable Care Act ReVivoandapos s spinal implants are the first to leverage the basic science of bone formation to reduce time to fusion while also diminishing complication rates decreasing operating room time and lowering overall cost ReVivo Medicalandapos s solution to improving spine fusion is a suite of continuously load sharing elastically deformable spinal implants By design the stiffness of ReVivoandapos s implants allows for micro deformation under physiologic loading This promotes continuous load sharing which we expect will lead to more rapid bony fusion The objective of this Phase I proposal is to demonstrate the efficacy of our elastically deformable continuously load sharing spinal implants to promote a faster and higher quality spinal fusion relative to existing plates In the proposed Phase I work we will establish that continuous load sharing through controlled micro motion will improve the rate and quality of interbody fusion in vivo In a clinically relevant in vivo large animal model we will correlate implant design to the clinically relevant metrics of subsidence screw backout and rate and quality of fusion We hypothesize that an elastically deformable continuously load sharing implant will reduce subsidence reduce screw backout and enhance the rate and quality of bony fusion relative to existing static and dynamic plates We will perform an anterior cervical discectomy and fusion on goats with animals grouped to receive either anterior a static plates b dynamic plates or c ReVivo Medicalandapos s elastically deformable plates Over a week period the progression of fusion will be monitored biweekly by plain x rays and by CT scans at and weeks Post mortem excised spines will be CT scanned and analyzed histologically to determine quality of fusion Serial x rays will be analyzed for evidence of subsidence screw backout implant migration and extent of fusion Data will be compared across treatment groups and across time points to assess differences PUBLIC HEALTH RELEVANCE Low back pain neck pain and related spinal disorders are ubiquitous in the United States with an estimated of the American population suffering from back pain at any one period For patients who fail conservative care spinal fusion has been the mainstay surgical procedure for decades In spite of the high number of favorable outcomes average time to solid bony fusion is months and lost work time is more than days Medical treatments are needed that improve outcomes reduce the long term effects of low back and neck pain and return patients back to activities of daily living and back to work more quickly ReVivo Medical LLC has developed the next generation of spinal fusion implants based on the fundamental science of bone formation ReVivoandapos s continuously load sharing implants will lead to more rapid bony fusion We believe this will foster faster spinal fusion which will ultimately lead to quicker healing fewer revisions and an earlier return to work