In Vivo and In Vitro Study of a Polylactide-Fiber-Reinforced ß-Tricalcium Phosphate Composite Cage in an Ovine Anterior Cervical Intercorporal Fusion Model.

A poly-70L/30DL-lactide (PLA70)-ß-tricalcium phosphate (ß-TCP) composite implant reinforced by continuous PLA-96L/4D-lactide (PLA96) fibers was designed for in vivo spinal fusion. The pilot study was performed with four sheep, using titanium cage implants as controls. The composite implants failed to direct bone growth as desired, whereas the bone contact and the proper integration were evident with controls 6 months after implantation. Therefore, the PLA70/ß-TCP composite matrix material was further analyzed in the in vitro experiment by human and ovine adipose stem cells (hASCs and oASCs). The composites proved to be biocompatible as confirmed by live/dead assay. The proliferation rate of oASCs was higher than that of hASCs at all times during the 28 d culture period. Furthermore, the composites had only a minor osteogenic effect on oASCs, whereas the hASC osteogenesis on PLA70/ß-TCP composites was evident. In conclusion, the composite implant material can be applied with hASCs for tissue engineering but not be evaluated in vivo with sheep.

Calvarial bone distraction with a contractile bioresorbable polymer.

The aim of the present study was to evaluate the possibility of mobilizing calvarial bone with a fully implantable and bioresorbable device. The animal model used was the New Zealand white rabbit (n = 12). An island bone flap attached to the dura mater was created in the parietal region and amalgam markers were placed in this bone flap and in the ipsilateral frontal bone. In one group of six rabbits (group 1), a specially processed contractile 70L/30D,L polylactic acid plate, 15 x 6 x 0.6 mm, was attached to the island flap by one extremity, and to the fixed ipsilateral frontal bone by the other. In group 2 (control), no plate was added. Bone marker movement was followed with serial radiography. In group 1, there was a progressive reduction in mean marker distance over the first 48 hours, and stability thereafter. In group 2 (control), mean marker distance remained stable until the second postoperative week, after which time there was a slight increase until the end of the experimental period. At 4 weeks, the mean marker separation differed significantly between group 1 (mean, -3.62 mm; SD, 0.79 mm) and group 2 (mean, 0.34 mm; SD, 0.14 mm; p <0.001). In conclusion, a totally implantable and bioresorbable device was successfully used to mobilize calvarial bone. Polymer contractility will likely constitute the basis of a new generation of bioresorbable distractors for use in craniofacial surgery.