[In vitro study of the properties of bioresorbable lactic acid polymer materials]

The potential applications of biodegradable osteosynthesis implants present many advantages over conventional metallic devices. Polyesters of the poly and hydroxy-acid type were recognized early as serious candidates. These polymers have demonstrated a very good biocompatibility and are biodegradable in vivo. After biological and chemical testing poly L. lactic acid 98 (PLA 98) was selected as a candidate. We used a static and dynamic investigation in vitro to assess firstly the material properties of PLA 98 and secondly how its characteristics could be modified within a physiological environment.

Michel Vert and colleagues have shown that polymers of lactic acid have a similar time to resorption providing they contain 98 per cent of the "L" form of the polymer. In vitro studies were assessed on bars made in PLA 98.

In a first time in vitro studies in traction and flexion on bars allowed an assessment of mechanical properties of PLA 98. In a second time stresses were applied on bars using a physiological environment (Haemacel - 37 degrees C). In a third time we assessed the mechanical properties at the temperature of 37 degrees C with dynamic tests on bars in traction and flexion.

The stress-strain curves on bars showed that the material is fragile. Sterilisation with ethylene-oxide did not affect the mechanical properties. When bars were placed in a thermostatically controlled (37 degrees C) physiological environment, the stress-strain curve showed that the material became ductile. With a temperature of 37 degrees C and with a frequency better than one hertz, the dynamic tests on bars showed that the material endurance is good up to 20,000 cycles. At 37 degrees C and at the end of one month, the Young modulus and the maximal strain before breaking lose 50 per cent of their initial value.

All things considered and as the digital value showed, the PLA 98 appear to be ten times less strong than steel. In a physiological environment the mechanical properties improved due to hydratation of the polymer. The material become quickly ductile or malleable. This allowed transient loading without causing breakage.

The mechanical properties of bioresorbable materials are very different from those of stainless steel and there is a learning curve in their utilisation. The PLA 98 polymer has demonstrated a very good biocompatibility and is totally biodegradable in vivo. With these results we think that PLA 98 can be used in clinical practice. Indications and clinical use should remain limited to bones regions with low applied stresses.