Consolidation of craniotomy lines after resorbable polylactide and titanium plating: a comparative experimental study in sheep.

The consolidation process of craniotomy lines in a skeletally immature large mammal was studied. A traditional narrow titanium miniplate was compared with a 0.5-mm-thick, 12-mm-wide absorbable punched self-reinforced poly-L-lactide (SR-PLLA) plate, both fixed with titanium miniscrews over bilateral parietal 2.5-mm-wide stable transosseous craniotomies on nine female sheep (16 to 20 months old). After 6, 12, 20, 52, and 104 weeks, cross-sectional histology, histomorphometry, and oxytetracycline chloride fluorescence studies were done to compare the healing process of the craniotomy lines and to study the biocompatibility and the degradation process of the SR-PLLA plate. The consolidation pattern supported the principle of guided tissue regeneration: under the wide, resorbable plate osseous bridging proceeded evenly throughout the line, whereas titanium plating led to bulky, uneven growth in the bone margins. All SR-PLLA-plated osteotomy lines had healed completely by 20 weeks, whereas none of the titanium-plated lines had consolidated during a follow-up of 1 year. The nonossified gaps were filled with dense connective tissue. Histomorphometric analysis showed that osseous bridging proceeded significantly faster on the resorbable plate side compared with the titanium side (p < 0.001). The osteoid surface fraction over the total trabecular surface was highest at 6 weeks, being 63 percent on the SR-PLLA side and only 36 percent on the titanium side. The oxytetracycline chloride fluorescence studies confirmed these findings. After 52 weeks, there was no osteoid or oxytetracycline chloride fluorescence left as a sign of terminated ossification, even in the nonconsolidated titanium sides. Microscopic cracking of the plate was evident at 12 to 20 weeks, and the first signs of active resorption were present at 52 weeks. After 2 years, the plate had disappeared and tiny polylactide particles were being actively reabsorbed. The biocompatibility of SR-PLLA and titanium was good, and no adverse cellular reactions to these materials were noted, except a clinical foreign body reaction caused by loosened titanium miniscrews. A densely punched, 0.5-mm-thick self-reinforced PLLA plate seems to retain its integrity for a sufficiently long time to complete osseous healing of a 2.5-mm-wide craniotomy line in the sheep calvarial area. A thin, wide fixation plate enables superior healing, especially in osseous defects. The degradation process of the SR-PLLA plate begins within 1 year and is far advanced after 2 years. By using absorbable SR-PLLA fixation plates instead of metallic plates, a subsequent operation for the removal of the implants can be avoided. SR-PLLA devices could thus be a potential additive or even alternative to metallic implants in craniofacial surgery.