Abstract
Objectives
Several studies have reported elevated blood cobalt (Co) and chromium (Cr) concentrations in patients with total knee replacements (TKRs). Up to 44% of tissue samples taken from patients with failed TKRs exhibit histological evidence of metal sensitivity/ALVAL. In simulated conditions, metal particles contribute approximately 12% of total wear debris in TKR. We carried out this investigation to determine the source and quantity of metal release in TKRs.
Design and Methods
We analysed 225 explanted fixed-bearing TKRs (Attune, Genesis II, NexGen, PFC, and Vanguard) revised for any indication. These were analysed using peer-reviewed [coordinate measuring machine (CMM)] methodology to measure the volumetric wear of the polyethylene (PE) bearing surfaces and trays. The trays were analysed using 2D profilometry (surface roughness-Ra) and light microscopy. Histological and blood metal ion concentration analyses were performed in a sub-sample of patients.
Results
The median (IQR) PE wear rate was 14 (6 to 20) mm3/year. Microscopic examination of the superior surface of trays exhibited pitting on 132 (59%) of trays. There was a statistically significant (p<0.05) increase in Rvk on the pitted area of trays for each design, indicating material removal from the pits compared to the unpitted area. The inferior surface of 116(51%) of trays displayed polishing, indicative of abrasive wear. The median(range) Co and Cr concentrations were 2.5µg/l (0.2–69.4) and 1.7µg/l (0.5-12.5) respectively in 40 patients. Of the tissue samples examined in 30 patients, 6 had at least “mild”-ALVAL infiltrate. All corresponding “ALVAL” explants were found to be pitted and/or show evidence of loosening of the tray.
Conclusion
This study provides further evidence that CoCr release in TKR appears to be an under-appreciated cause of adverse clinical outcomes. The generation of metal particles was predominantly from the metal tray, which may explain elevated metal ions after TKRs, despite no direct metal-on-metal contact.