We sought to determine what dimensional changes occurred from wear testing of a total knee implant, as well as whether any changes developed within the polyethylene subsurface. Three fixed bearing implants underwent wear simulator testing to 6.1 million cycles. Gravimetric analysis and micro-CT scans were performed pre-test, mid-test, and post-test. Wear volume and surface deviations were greater during 0–3.2 million cycles (91±12 mm3) than from 3.2–6.1 million cycles (52±18 mm3). Deviations (wear and creep) occurred across all surfaces of the tibial inserts, including the articular surface, backside surface, sides, and locking mechanism. No subsurface changes were found. The micro-CT results were a useful adjunct to gravimetric analysis, better defining the dimensional changes that occurred with testing and ruling out subsurface fatigue.
Implant wear continues to be a limitation of total knee replacement (TKR). Wear simulator studies are a valuable screening tool in new implant development. The purpose of this study was to determine the ability of micro-CT to prospectively measure wear in TKR implants during a wear simulator trial. Three identical cruciate-retaining, fixed bearing cobalt-chromium-molybdenum (CoCrMo) on conventional EtO-sterilized polyethylene TKA implants underwent wear simulator testing up to 3.2 million cycles using gait inputs; loaded-soaks were used to correct for fluid absorption. The implants were weighed and scanned with micro-CT (at 50 micron resolution) before and after testing. The gravimetric mass was converted to volume based on the density of polyethylene. Volume change due to wear was calculated from both the gravimetric and micro-CT methods. The pre- and post-wear test micro-CT geometries were co-registered and the deviations between the two were measured.BACKGROUND:
METHODS:
The most common bearing couple used in total knee arthroplasty (TKA) is ultra-high molecular weight polyethylene (UHMWPE) articulating against a CoCrMo alloy femoral component. Although this couple has demonstrated good clinical results, UHMWPE wear has been identified as one of the principal causes for long-term failure of total knee joint replacements1 indicating a need for improvements in TKA bearings technology. The wear resistance of UHMWPE can be improved by radiation crosslinking; however, in order to get the full benefit of this improved wear resistance, an abrasion resistant ceramic counterface is necessary.2 Since the radiation crosslinking degrades mechanical properties, it is also important to have an optimized radiation dose and subsequent processing. The purpose of this study was to evaluate the long-term wear performance of VERILAST Technology comprising two advanced bearing technologies, abrasion resistant OXINIUM femoral components (OxZr)3-4 and wear/strength optimized 7.5 Mrad crosslinked polyethylene (7.5-XLPE).5 Three component assemblies of LEGION(tm) cruciate retaining (CR) OxZr femoral components, 7.5-XLPE tibial inserts were tested on an AMTI knee simulator under displacement control at 1 Hz frequency as described previously.2 The tibial inserts were manufactured from compression molded GUR 1020 UHMWPE, radiation crosslinked to 7.5 Mrad dose, remelted to extinguish free radicals, and sterilized by EtO. The wear test was conducted for 45 Mcycle, which was considered to be a conservative estimate for the amount of cycles that would occur during 30 years of typical in-vivo use based on the relationship between patient age and the number of loading cycles as reported in the literature.6-8Introduction
Materials and Methods
A new hinge knee system (LEGION HINGE, Smith &
Nephew, Memphis, TN) was designed to treat gross knee instability resulting from loss of collateral ligament function, femoral and/or tibial bone loss, or from comminuted fractures of the proximal tibia or distal femur. The knee system is offered with an insert that guides the motion of the implant for kinematic improvement. The purpose of this study was to evaluate kinematic and wear performance of this novel hinge knee replacement system. The kinematics and kinetics of the Guided Motion (GM) hinge knee were assessed for a deep knee bend using a numerical lower leg simulator. Measurements of A/P translation and I/E rotation were compared to 3D MRI data of healthy weight bearing knees and measurements of M/L patella shear forces were compared to a standard primary knee implant. Three GM knee systems were tested for wear performance. All metal components were fabricated from cobalt chrome except for the Ti-6Al-4V insert locking screw. All plastic components were fabricated from UHMWPE. Wear testing was conducted on an AMTI 6-station force controlled knee simulator for approximately 5 million cycles under ISO 14243-1 load/motion profiles and soft tissue constraints. Simulation results showed that up to 130° of flexion the anterior/posteror (A/P) translation and internal/external (I/E) rotation followed a similar path over the flexion range compared to the MRI data. The magnitude of A/P translation at 130° was 9.5 mm for the GM design compared to 15.7 mm for the MRI data. The magnitude of I/E rotation at 130° was 18° for the GM design compared to 20.8° for the MRI data. The GM design showed a maximum M/L patella shear force of 456.8 N compared to 1152.4 N for a standard primary knee design over the flexion range. All constructs successfully completed wear testing and were fully functional with no issues for binding of the mating parts. All polyethylene components showed only burnishing on the articulating surfaces. The volumetric wear rate of polyethylene components was 17.54±1.24 mm3/Mcycle. The volumetric wear rate of the metal components (excluding femoral and tibial tray) was 0.045±0.01 mm3/Mcycle. Testing showed the GM design has A/P and I/E kinematics that are similar to those seen in a normal healthy knee and good patella tracking as evidenced by the low M/L patella shear forces. The wear rate of the polyethylene parts was within the range of wear rates published in the literature for primary knee designs (up to 35.8 mm3/Mcycle). The low metal wear rate indicates that fretting and corrosion of the components was minimal. We conclude the GM design more closely replicates the kinematics of the natural knee without compromising the wear characteristics. This could lead to better outcomes for the patient population that requires a hinge knee implant.
Due to their superior wear characteristics, oxidized Zr-2.5Nb heads are used with hip stems made of conventional orthopaedic alloys. Galvanic interactions between Zr-2.5Nb (Zr) and Ti-6Al-4V (Ti), cobalt-chromium (CoCr), and 316L stainless steel (SS) alloys were evaluated. Galvanic current density was measured for Zr/Ti,Zr/CoCr, Zr/SS, CoCr/Ti, and CoCr/SS couples under static conditions in aneutral Ringer’s solution and in an acidic (1.7 pH) solution. To simulate fretting, one or both coupled alloys in the neutral solution subsequently were abraded by a bone cement pin (82 MPa Hertzian stress). An extended(7-day) static test in the acidic solution was performed for Zr/SS and CoCr/Ti to simulate crevice conditions. The dissolved metal ion concentration was determined using direct coupled plasma emission spectrometry. Mean initial current densities of the Zr/SS, SS/CoCr,Zr/CoCr, CoCr/Ti, and Zr/Ti couples were 3.0, 0.36, 0.16, 0.05, and 0.04μA/cm2, respectively, in the neutral solution, and 0.57, −0.29, 0.04, 0.02, and 0.03 μA/cm2, respectively, in the acidic solution (positive when first alloy was anode). Within 30 minutes, all values decreased below 0.02μA/cm2. The current densities increased by orders of magnitude under fretting conditions. When both alloys were abraded, the highest values were minus;677 and 464 μA/cm2 for CoCr/Ti and Zr/SS, respectively. In the extended static test of Zr/SS, the mean total metal ion concentration decreased from 8.15 mg/L when the alloys were uncoupled to 4.50 mg/L(p=0.007) when they were coupled. For CoCr/Ti, the change from 1.28 to 1.72mg/L when the alloys were coupled was not statistically significant(p=0.22). With its strong tendency to passivate, the Zr alloy produced galvanic interactions within the range observed with conventional alloy couples. Its anodic characteristic helped protect SS in a galvanic couple.
An instrumented extensively porous coated stem was implanted in composite femur models (n=3) and mechanically tested. The stem stresses resulting from proximal overbroaching, ETO, cable grips, and various cable and strut constructs were determined.
Stem stresses increased 98 when a proximally loose stem was combined with an ETO using laboratory tests. This stress was decreased by up to 37 percent when a long trochanteric plate was utilized.
An instrumented extensively porous coated stem was implanted in composite femur models (n=3) and mechanically tested. The stem stresses resulting from proximal overbroaching, ETO, cable grips, and various cable and strut constructs were determined.
Stem stresses increased 98 when a proximally loose stem was combined with an ETO using laboratory tests. This stress was decreased by up to 37 percent when a long trochanteric plate was utilized.
