IN VIVO EVALUATION OF THE HOLDING POWER OF DEGRADABLE MAGNESIUM CALCIUM ALLOY SCREWS AND SURGICAL STEEL SCREWS IN RABBIT TIBIAE

Abstract

Magnesium calcium alloys are promising candidates for an application as biodegradable osteosynthesis implants [1,2]. As the success of most internal fracture fixation techniques relies on safe anchorage of bone screws, there is necessity to investigate the holding power of biodegradable magnesium calcium alloy screws. Therefore, the aim of the present study was to compare the holding power of magnesium calcium alloy screws and commonly used surgical steel screws, as a control, by pull-out testing.

Magnesium calcium alloy screws with 0.8wt% calcium (MgCa0.8) and conventional surgical steel screws (S316L) of identical geometries (major diameter 4mm, core diameter 3mm, thread pitch 1mm) were implanted into both tibiae of 40 rabbits. The screws were placed into the lateral tibial cortex just proximal of the fibula insertion and tightened with a manual torque gauge (15cNm). For intended pull-out tests a 1.5mm thick silicone washer served as spacer between bone and screw head. Six animals with MgCa0.8 and four animals with S316L were followed up for 2, 4, 6 and 8 weeks, respectively. Thereafter the rabbits were sacrificed. Both tibiae were explanted, adherent soft tissue and new bone was carefully dissected around the screw head. Pull-out tests were carried out with an MTS 858 MiniBionix at a rate of 0.1mm/sec until failure of the screw or the bone. For each trial the maximum pull-out force [N] was determined. Statistical analysis was performed (ANOVA, Student's t-test).

Both implant materials were tolerated well. Radiographically, new bone was detected at the implantation site of MgCa0.8 and S316L, which was carefully removed to perform pull-out trials. Furthermore, periimplant accumulations of gas were radiographically detected in MgCa0.8. The pull-out force of MgCa0.8 and S316L did not significantly differ (p = 0.121) after two weeks. From 6 weeks on the pull-out force of MgCa0.8 decreased resulting in significantly lower pull-out values after 8 weeks. Contrary, S316L pull-out force increased throughout the follow up. Thus, S316L showed significantly higher pull-out values than MgCa0.8 after 4, 6 and 8 weeks (p<0.001).

MgCa0.8 showed good biocompatibility and pull-out values comparable to S316L in the first weeks of implantation. Thus, its application as biodegradable osteosynthesis implant is conceivable. Further studies are necessary to investigate whether the reduced holding power of MgCa0.8 is sufficient for secure fracture fixation. In addition, not only solitary screws, but also screw-plate-combinations should be examined over a longer time period.