Cerapedics launches P-15L peptide-enhanced bone graft IDE trial
Cerapedics said today it launched a new investigational device exemption trial looking to explore the safety and efficacy of its next-gen P-15L peptide enhanced bone graft in transforaminal interbody fusion surgeries. The Westminster, Colo.-based company said it has enrolled the first patients in the study, which aims to enroll a total of 364 patients with degenerative disk disease at 30 sites across the US. “We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures. More than 300,000 people in the U.S. suffer from degenerative disk disease that leads to pain and nerve irritation and often requires surgery. Our first-generation bone graft is already approved for anterior cervical discectomy and fusion procedures, and this pivotal study in TLIF procedures will be instrumental in a second premarket approval application for our next-generation P-15 technology in the years ahead,” CEO Glen Kashuba said in a press release. The trial will compare the company’s P-15L enhanced bone graft against an autologous bone graft during TLIF surgery, Cerapedics said. The P-15L bone graft is based on biomimetic small peptide tech intended to support bone growth through cell attraction, attachment and activation. “This important first patient enrolled signifies the culmination of substantial efforts on the part of many external and internal collaborators. We are grateful for all of the efforts that have gotten us to this poi...
CONCLUSIONS: Using local bone dust as cage filling material resulted in fusion rates similar to those for an iliac bone graft, while avoiding potential complications and pain caused by iliac bone harvesting. A higher rate of extragraft bone bridge formation was achieved by implanting local bone dust outside the cage. PMID: 31174186 [PubMed - as supplied by publisher]
Conclusions: A significant proportion of patients with degenerative cervical disc disease show remarkable recovery after ACDF.
Orthofix (NSDQ:OFIX) said yesterday that it won FDA approval for its M6-C artificial cervical disc, intended for treating patients suffering from cervical disc degeneration. The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April. The newly cleared M6-C is a next-gen artificial disc intended to replace an intervertebral disc damaged by cervical disc degeneration. The system is designed to restore physiological motion to the spine and is indicated as an alternative to cervical fusion, Orthofix said. Pre-market approval of the de...
Conclusions: In ACDF with plate fixation, cortical ring allograft filled with DBM group showed similar radiological and clinical outcomes compared with those of the autograft group. If the metal plate is reinforced, using cortical ring allograft could be a viable alternative to autograft. PMID: 30472821 [PubMed - as supplied by publisher]
ConclusionsIn approximately 90% of patients, bony fusion is accomplished one year after ACDF. As there is no generally accepted definition of bony fusion, different measuring techniques cannot be compared to a gold standard and it is impossible to determine the most accurate method. Variations in study design hamper conclusions on optimising the rate of bony fusion by choice of material and/or additives. Insufficient attention is paid to correlation between bony fusion and clinical outcome.Graphical abstractThese slides can be retrieved from electronic supplementary material.
Conditions: Myelopathy; Cervical Radiculopathy; Neck Pain Intervention: Procedure: Anterior cervical discectomy and fusion surgery Sponsors: Rutgers, The State University of New Jersey; Cervical Spine Research Society Not yet recruiting