A post-clinical retrieval analysis was performed on 43 polyethylene tibial components of a contemporary total knee arthroplasty system with implantation duration between 12 and 80 months. Components were scored for eight potential modes of surface wear or damage on the top and back surfaces. Moderate backside wear of 4.1μm per year was documented by measuring the extent of manufacturer’s engraved lettering removal. Neither the topside nor backside score correlated with duration of in vivo function. No component experienced topside or backside delamination, cracking, or significant deformation. The greatest contribution to wear and damage score was pitting and scratching secondary to bone cement debris. The extent of both wear and damage experienced by these components was moderate, in comparison with that previously reported with older implant systems.

Introduction and Aims: Due to relative motion that can occur between the polyethylene articular surface and tibial tray, backside wear of modular tibial components can be a significant contributor to wear in TKR. This study examines the backside wear performance of a tibial component system from both a laboratory and clinical perspective.

Method: Polyethylene components, CR and PS, from the NexGen knee system (Zimmer Inc.) were evaluated for backside wear. These components were identified on the back surface by the manufacturer with engraved lettering of a depth ranging from 20 to 30 micrometers. Twenty-seven components retrieved after 24 to 80 months in-situ were evaluated along with six components having undergone three million cycles of laboratory knee function simulation. Backside wear was quantified by engraving mark depth and screw hole recess penetration measurements utilising a New View 5000 scanning white light interferometer (Zygo). The severity of third-body abrasion was also recorded.

Results: This particular knee system utilised a peripheral rail and dovetail polyethylene locking mechanism which demonstrated little relative polyethylene to tibial tray motion during joint function simulation. Simulator testing produced backside wear of 6.4 micrometers/million cycles or 4.5 mm3/million cycles. This backside wear represented 30% of total component wear as measured gravimetrically. Backside wear in the clinically retrieved components was sufficient to completely remove the manufacturer’s engraving marks on only three of 27 components. The remaining 24 components all experienced backside wear insufficient to remove all engraving. The severity of third-body abrasion (typically bone cement) was generally associated with greater backside wear. Two of the three clinically retrieved components with worn-through lettering had evidence of significant third-body wear. In 11 clinically retrieved components (utilised on tibial trays with screw holes), backside wear was measured by comparing engraving mark depth in unworn polyethylene areas over screw recesses with engraving mark depth in areas of polyethylene contact with the tibial tray. These components demonstrated 14 micrometers of wear at an average of 37 months in-situ or 4.4 micrometers per year. None of the retrieved components were clinically associated with osteolysis.

Conclusion: In this particular tibial component system, backside wear was moderate for both the joint simulator and clinically retrieved specimens. Backside wear does not appear to be the major contributor of total polyethylene wear in this implant system. The presence of third-body particles contributed to greater wear.

A method to extensively cross-link polyethylene for total hip application has been developed and tested in hip wear simulation. Extensively cross-linked polyethylene was prepared by exposing GUR 1050 polyethylene resin to 90 kg to 110 kg of e-beam radiation. For total hip application, the material was evaluated in an AMTI joint simulator in normal debris-free conditions and in a Shorewestern simulator for the adverse condition of added bone cement and aluminum oxide debris. The normal condition testing was conducted to 30 million cycles, while the adverse condition tests were conducted to 5 million cycles. Femoral head sizes from 22 mm to 46 mm were evaluated. The wear performance of extensively cross-linked material was compared to control material (GUR 1050 gamma sterilized in nitrogen). The results demonstrate a significant improvement in wear (greater than 80 percent reduction) of extensively cross-linked GUR 1050 acetabular components compared to the control acetabular components. The adverse condition wear of both materials was greater than the normal wear; however, when compared to the controls, the extensively cross-linked material had improved wear performance in both normal and adverse conditions. The wear of femoral heads larger than normal 32 mm sizes showed accelerated wear in the control material and desirable low wear in the extensively cross-linked condition. The polyethylene particles generated in the wear simulation were of similar size and shape between the extensively cross-linked and controlled polyethylene. As demonstrated in the laboratory simulation, this extensively cross-linked polyethylene has the potential to substantially reduce particular debris generation in total hip applications. A multicenter randomized controlled clinical study of extensively cross-linked and control acetabular components is ongoing.