A1062. BIOLOGIC FIXATION OF AN ASYMMETRIC TITANIUM PARTICLE POROUS COATING IN A LOAD-BEARING ANIMAL MODEL

Abstract

This study evaluated the biologic fixation of two different titanium porous coatings: a clinically successful sintered spherical bead coating [1] and a new sintered asymmetric particle coating (STIKTITE™, Smith & Nephew). The spherical bead coating has a porosity of about 50% and an average pore size of about 220 μm, whereas the STIKTITE coating has greater porosity (about 62%) and slightly smaller average pore size (about 200 μm). Biologic fixation was assessed using a load-bearing ovine model in which coated semi-circular disc implants were inserted into a defect created in the cancellous bone parallel to and approximately 3 mm below the medial tibial plateau [2] similar to the method reported by Ignatius [3]. The implants were slightly thicker than the defect created, producing a 0.2-mm overall pressfit. Initial implant stability was assessed using mechanical push-out (n = 3) immediately after implantation into cadaveric ovine bone. Quantitative mechanical push-out testing and qualitative histology (n = 9 and n = 2, respectively, per group per time point) was performed after six and 26 weeks in vivo.

The time-zero average peak push-out load (±S.D.) of the STIKTITE group (95±3 N) was found to be significantly greater (p < 0.02) than that of the spherical bead group (36±5 N). By six weeks in vivo, the average peak push-out load for the STIKTITE group was up to 1001±362 N, and that for the spherical bead group was up to 985±425 N, both representing a significant increase compared to their time-zero results (p < 0.0005). From six to twenty-six weeks in vivo, there was again a significant increase in the peak push-out load irrespective of group (p < 0.0005), with the average peak push-out loads up to 1620±406 N and 1444±446 N for the STIK-TITE and spherical bead groups, respectively. Histology revealed bone ingrowth in both groups that confirmed the findings of the mechanical push-out testing. While the STIKTITE group showed a trend toward greater biologic fixation, overall there was insufficient evidence to support differences between the two groups (p = 0.47) irrespective of the amount of time in vivo.

The results of this study confirm the ability of the STIK-TITE coating to achieve superior initial stability. This improved initial stability reduces the reliance on adjunct fixation (such as screws) or large amounts of press-fit to prevent micromotion and create an environment suitable for long-term bone ingrowth. The results also suggest that the STIKTITE coating had a tendency to initiate and maintain bone ingrowth under load-bearing conditions to a level greater than that of a clinically successful sintered bead coating. Because loading of the implant can cause micromotion at the bone/implant interface, models like the one used in this study likely provide a more challenging and realistic representation of anticipated clinical conditions than models with minimal implant loading.