This study reports on the clinical and wear performance of a prospective randomised controlled trial comparing highly cross-linked (XLPE) to conventional polyethylene (PE) in total hip arthroplasty at five years minimum follow-up. One hundred patients enrolled in a prospective randomised controlled trial received identical hybrid total hip arthroplasties with the exception of the polyethylene insert. Fifty patients received a PE liner (2.5 MRads; gamma-in-nitrogen sterilization) and fifty patients received a XLPE liner (10Mrads; gas-plasma sterilization). Clinical outcomes were determined using Harris Hip, WOMAC and SF-12 scores by an independent study nurse. Femoral head penetration rates were determined using a validated radiographic technique (Hip Analysis Suite 8.0.1.1) based on radiographs at six weeks, one year and yearly post-operatively. Linear regression analysis was performed for both the entire polyethylene groups and on each patient, where the slope represents the steady state head penetration rate (after bedding in) from one to five years follow-up. None of the patients were lost to follow-up, however, nine patients were deceased before their five year follow-up. Two patients have been revised for loose stems. At average follow-up of 6.0 years (range 5.1–6.8 years), there were no differences in Harris Hip, WOMAC or SF-12 scores. XLPE had a significantly lower (p= 0.03) steady-state head penetration rate of 0.018 mm/year compared to 0.050 mm/year for XLPE (approximately 64% reduction). Analysis of individual patient’s head penetration rates demonstrated a similar significantly lower rate with XLPE (0.004 ± 0.067 mm/year) compared to PE (0.045 ± 0.083 mm/year). Interestingly, when examined by gender, the male PE group had a significantly higher head penetration rate (0.081 ± 0.084 mm/year) than both the male and female XLPE (−0.013 ± 0.104, 0.011 ± 0.074 mm/year, respectively). At minimum five years follow-up, there were no clinical differences between groups. After bedding-in, there was a significant lower head penetration rate with XLPE compared to PE. Thus, mid-term follow-up appears to demonstrate a significant wear reduction (based on head penetration rates) afforded by first generation XLPE. Long-term follow-up is required to demonstrate the clinical benefit of this new material.
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.
