Composites of unsintered hydroxyapatite (HA) and poly(L-lactide) (PLLA) reinforced by compression forging are biodegradable, bioactive, and have ultrahigh strength. However, foreign body reactions to PLLA and physical irritation can occur when not covered by bone. We aimed to confirm the relationships between the depth of the implanted HA-PLLA threaded pins and the new bone formation. We inserted HA-PLLA composite threaded pins (diameter: 2.0 or 4.5 mm) into the femoral and tibial bones of 32 mature male Japanese white rabbits (weight 3.0-3.5 kg) with the pin head 1 or 0 mm below or protruding 1 or 2 mm above surrounding cortical bone. Eight euthanized rabbits were radiologically and histologically assessed at various intervals after implantation. Bone bridging was complete over pins of both diameters at ~12 weeks, when inserted 1 mm below the surface, but the coverage of the pins inserted at 0 mm varied. Bone was not formed when the pins protruded >1 mm from the bone surface. No inflammation developed around the pins by 25 weeks. However, foreign body reactions might develop if composites are fixed above the bone surface, and intraosseous fixation would be desirable using double-threaded screws or a countersink to avoid screw head protrusion.
Keywords: bioactive; biodegradable; composite; foreign body reaction; poly(L-lactide).