Charles Sternberg, Associate Editor09.28.22
An independent clinical research team in New York, lead by Ralph Rahme, M.D., F.A.C.S., has published their clinical findings, describing treatment outcomes with OssDsign PSI in the largest U.S. cohort to date.
The study included 18 patients who underwent cranioplasty, showing that the procedure was successful in all cases, and that no implant-related complications occurred during a 6-month median follow-up period. The clinical paper is published in the journal World Neurosurgery.
OssDsign Cranial PSI is a patient-specific cranial implant that reduces the risk of infection and implant failure in the treatment of cranial bone defects.
“In our single-center evaluation of OssDsign Cranial PSI, our preliminary findings indicate that the use of this implant is associated with favorable results, including a 0% rate of implant-related complications and good-to-excellent cosmetic outcomes in all patients. Those results are well in line with previous studies, lending further support for the routine use of this implant in clinical practice,” said primary investigator Ralph Rahme, M.D., F.A.C.S., Division of Neurosurgery at SBH Health System, New York, USA.
“We are excited by the uplifting data presented by Dr. Rahme and his clinical research team. The results from the largest U.S. case series to date point toward the uniqueness of our osseointegrative technology and add to a growing body of evidence and publications in peer-reviewed journals highlighting the low complication rates seen with the use of OssDsign Cranial PSI,” added Morten Henneveld, CEO of OssDsign.
The study included 18 patients who underwent cranioplasty, showing that the procedure was successful in all cases, and that no implant-related complications occurred during a 6-month median follow-up period. The clinical paper is published in the journal World Neurosurgery.
OssDsign Cranial PSI is a patient-specific cranial implant that reduces the risk of infection and implant failure in the treatment of cranial bone defects.
Findings
The study, “Skull reconstruction using a custom-made, 3D-printed, hydroxyapatite-titanium cranioplasty implant: largest single-center U.S. experience,” evaluated treatment outcomes in 18 patients who received OssDsign Cranial PSI following extensive craniectomy, due to traumatic brain injury, hemorrhagic stroke, or ischemic stroke, between February 2019 and February 2022. The evaluation shows that cranioplasty was successful in all patients and that only minor postoperative complications, all unrelated to the implant, occurred in 3 patients. At a median follow-up period of 6 months (1-38 months), no patients had suffered implant-related complications such as reoperation or explantation due to infection. Furthermore, the cosmetic result was rated good to excellent in all of the patients.“In our single-center evaluation of OssDsign Cranial PSI, our preliminary findings indicate that the use of this implant is associated with favorable results, including a 0% rate of implant-related complications and good-to-excellent cosmetic outcomes in all patients. Those results are well in line with previous studies, lending further support for the routine use of this implant in clinical practice,” said primary investigator Ralph Rahme, M.D., F.A.C.S., Division of Neurosurgery at SBH Health System, New York, USA.
“We are excited by the uplifting data presented by Dr. Rahme and his clinical research team. The results from the largest U.S. case series to date point toward the uniqueness of our osseointegrative technology and add to a growing body of evidence and publications in peer-reviewed journals highlighting the low complication rates seen with the use of OssDsign Cranial PSI,” added Morten Henneveld, CEO of OssDsign.