OssDsign AB has announced positive results from a retrospective study of OSSDSIGN Cranial PSI that has been accepted for publication in World Neurosurgery.
The retrospective study carried out at Karolinska University Hospital in Sweden describes the clinical outcome of 50 patients who underwent cranioplasty with a total of 53 OSSDSIGN Cranial implants. 64% of the patients had experienced previous implant failures with other treatment options (autologous bone and/or alloplastic materials). 40% of the patients had previous problems with infections, which is one of the most common complications leading to implant failure and subsequent explantation in cranioplasty.
Improved clinical outcome
In this patient cohort, the explantation rate due to early post-operative infection for OSSDSIGN Cranial was 1.9% (1/53) at a median follow-up time of 25 months. The explanted patient was successfully re-implanted with OSSDSIGN Cranial without any signs of complications at the 6-month post-op follow-up. The publication concludes that OSSDSIGN Cranial appears to have improved the clinical outcome, and particularly notes the regenerative effect of the implant as an important factor in achieving successful long-term outcome.
“We are extremely happy to be able to show peer-reviewed data on the clinical outcome of OSSDSIGN Cranial. The data correlates well with our own post-market-surveillance data which is based on a larger number of patients. It is thus becoming increasingly clear that the regenerative features of our material can be turned into beneficial clinical outcomes. We will now continue our mission to make our technology available to more patients worldwide,” says Anders Lundqvist, CEO of OssDsign.
Photo of Anders Lundqvist: OssDsign