SYNOVIAL FLUID CONSTITUENTS AFFECT POLYETHYLENE WEAR IN TOTAL KNEE REPLACEMENTS

Abstract

Attempts have been made to develop standardise guidelines for knee implant wear testing of polyethylene (PE). The current ISO-14243-3 standard recommends the use “calf serum”, without giving ranges on the specific protein constituents and characteristics. In the present study, three types of frequently used calf sera with various protein constituents (albumin, globulins) were utilised. The effect of osmolality and hyaluronic acid (HA) was also assessed. An attempt was made to identify synovial fluid (SF) characteristics that may be responsible for the boundary lubrication in the joint with the goal to develop a more clinically relevant lubricant.

Twenty samples of SF were drawn from twenty patients and analyzed. Specific protein constituents and osmolality were then compared to three calf sera used for wear testing. Test One (six million cycles (Mc)): Bovine calf serum (BCS), newborn calf serum (NCS) and alpha-calf serum (ACS) were diluted with distilled water (DW). Test two (5.5Mc): ACS with an osmolality of 312 ± 1.00 mmol/kg (closest to clinical osmolality; diluted with phosphate buffered saline, PBS) and 145 ± 2.00 mmol/kg (diluted with DW) were consecutively tested. HA was added at a concentration of 1.5g/l. Modular total knee replacements of cruciate retaining design (GUR 1050, 10mm PE insert) were used.

ACS diluted with PBS appeared to be of closest specific protein constituents and osmolality when compared to SF. The wear rate for BCS was 21.81 ± 2.48 mg/Mc, 17.05 ± 3.25 mg/Mc for NCS, and 13.44 ± 0.79 mg/Mc for ACS (p < 0.016). Decreased osmolality amplified the PE wear by a factor of 2.3 (p = 0.020). Adding HA increased the PE wear by a factor of two (p = 0.002).

There was significant difference in PE wear rates between the three calf-sera. BCS and NBC did not have clinically relevant levels of specific protein constituents. This study strongly suggests that current standards for total knee wear testing should be revised to enable more controlled wear testing under more clinically relevant conditions. It is suggested to be of particular importance when new bearing materials, such as cross-linked PE’s, are evaluated and proposed for clinical application.