July 20,2020

Osteopore International Pte Ltd, a global leader in regenerative implants, today revealed new data that demonstrates the long-term safety and efficacy of Osteoplug, a 3D printed bioresorbable polycaprolactone (PCL) bone graft implant, that enables the regeneration of a patient's skull bone tissue to cover and protect burr holes created during brain surgery or tumour biopsy. After healing is complete, no foreign material is left behind in the skull.

Findings From a Landmark 10-year Clinical Study

With results of a retrospective study already published in the Journal of 3D Printing in Medicine,Osteopore has evaluated and proven the safety of using PCL implants in 174 patients over a 10-year period. Overall, the 275 implants that were used and implanted did not increase the rate of surgical complications, and showed zero reports of infection originating from the implants.

To further illustrate these findings, computed tomography (CT) scans of two patients were conducted at various time intervals post-operatively: at 30 days and 15 months for the first case, and at 8 years for the second case. Visible radiopacity on both scans suggested tissue regeneration, while both patients eventually recovered with no post-surgery complications and no documented skin depressions.

In another case, an Osteoplug implant was explanted 3.5 months after the initial surgery, from an 89-year-old male patient suffering from recurrent chronic subdural hematoma (CSDH). Connective tissue was found forming around the scaffold of the harvested implant, presenting evidence that the implant had encouraged and allowed for blood vessel infiltration, paramount to bone and tissue regrowth.

A New Era of Regenerative Surgery

For the longest time, titanium burr hole covers have been the favourable option for skull defects and other forms of brain surgery. However, according to several clinical papers in Interdisciplinary Neurosurgery and the Journal of Craniofacial Surgery, titanium burr hole covers have caused some cosmetic and functional issues among patients in the post-surgery stage.

"Titanium burr hole covers have long been developed and used for this purpose, but there have been cases which have cited palpability, visibility, infection, exposure and pain associated with using titanium plates and screws that have necessitated removal," cited the authors as the reason for creating and evaluating an implant made from 3D printed bioresorbable PCL, which allows for natural tissue and blood vessel ingrowth.

Currently, Osteopore is the only company globally that manufactures regenerative implants for bone healing. Its core technology allows for its implants to be capable of restoring the human skeleton with a reduced risk of post-surgery complications, commonly associated with permanent bone implants. To date, its products have been used in 30,000 surgeries globally and counting, and have significantly improved the quality of life for these patients worldwide.