Materials and Methods

Components from the Zimmer NexGen CR Knee Replacement System were used. Europium (Eu) and Gadolinium (Gd)-stearates were mechanically mixed with GUR1050 UHMWPE resin to obtain two tracer-UHMWPE resins containing 49.1±1.5 ppm Eu and 68.8±1.6 ppm Gd, respectively. 12 grams of the Eu-doped resin was placed on the bottom, 10 grams of virgin GUR1050 resin was placed in the middle, and 10 grams of Gd-doped resin was placed on the top to mold NexGen CR tibial inserts. The backside was then machined to interlock with the tibial baseplate. The minimum insert thickness was 10 mm. All inserts were packaged in nitrogen and gamma sterilized.

The wear test was conducted on a 4-station knee simulator in displacement-control mode. Simulator input was obtained from ISO 14243-3 and from gait of 30 NexGen TKR subjects, previously categorized into low (AP-L) and high (AP-H) anteroposterior motion groups. Per station, each insert was sequentially subjected to ISO, AP-L, AP-H motion for 2 Mc at 1 Hz. Subsequently, the ISO profile was repeated. Tibial inserts were weighed and lubricant samples were taken after every 0.5 Mc interval. Knowing the Eu and Gd concentrations from ICP-MS analysis, and normalizing those to the concentrations in the polyethylene inserts, the localized (Eu – backside; Gd – topside) wear was calculated. Wear particle analysis was conducted following established protocols.

Methods

This study included 59 tibial inserts of a cruciate retaining TKR design (Nexgen, Zimmer Inc.). The patients' age, sex, weight, height, and implant size were obtained. All implants were scanned with a coordinate measuring machine. Volumetric wear was determined using an autonomous mathematical reconstruction method (Figure 1). Radiographs were used to determine the anatomic lateral distal femoral angle (aLDFA), anatomic medial proximal tibial angle (aMPTA), femoral tilt angle (FTA) and posterior tibial slope (PTS). Also, the patella position was assessed using the Blackburne-Peel Index (BPI) and the Insall-Salvati Ratio (Figure 2). General linear modeling (SPSS) was conducted in order to determine the most significant patient and implant positioning factors on wear rate.

Methods

The four-station bioreactor was housed in an incubator. The dual axis concept of this simulator approximates the rolling-gliding kinematics of the joint. Twelve 32 mm alumina-zirconia composite femoral heads (Biolox®delta, CeramTec GmbH, Germany) and twelve 32 mm CoCrMo femoral heads (Peter Brehm GmbH, Germany) made up the testing groups. Each head articulated against a cartilage disk of 14 mm diam., harvested from six months old steers. Free-swelling control disks were obtained as well. Testing was conducted in Mini ITS medium for three hours daily over 10 days applying a load of 40 N (∼2 MPa). PG/GAG was determined using the dimethylmethylene blue (DMMB) assay. Hydroxyproline was analyzed by high performance liquid chromatography coupled to a mass spectrometer. Additionally, at test conclusion, chondrocyte survival was determined using Live/Dead assay. Histological analysis was performed using a modified Mankin score. The effect of articulating material (ceramic, CoCrMo) on the various outputs of interest was evaluated using ANOVA. Blocking was performed with respect to the animals. The Mankin scores were compared using the Kruskal–Wallis test.

Methods

Eighty-one retrieved UHMWPE NexGen cruciate-retaining tibial liners (Zimmer, Warsaw, IN) with an average time in situ of 5.27±2.89 years were included in the study. Metrology data for the surfaces of the tibial liners were obtained with a coordinate measuring machine (OGP, Rochester, NY). Using a laser scanner with two micrometer depth accuracy, at least 400,000 measurement points were taken by investigator #1. Areal thickness changes were mapped for the lateral and medial sides with the help of an autonomous mathematical reconstruction algorithm and volume loss was calculated based on wear scar area and local thickness change. Investigator #2, blinded from these results, measured the minimum thickness of the medial and lateral tibial plateau using a dial indicator with a spherical tip radius of 3mm. Twenty-three short term retrievals (3 to 4 per implant size), removed due to infection and without any signs of wear, served as “unused” reference. Linear penetration was then calculated by subtracting the minimum thickness of each plateau from the average thickness of the reference components.

Methods

A four station simulator (Figure 1), mimicking joint load and motion, was used for testing. The simulator is housed in an incubator, which and provides the necessary environmental conditions for cartilage survival. Articular cartilage disks (14mm in diameter) were obtained from the trochleas of six to eight months old steer for testing and free-swelling controls. Disks (n=8 per material) were placed in porous polyethylene scaffolds within polypropylene cups and mounted onto the simulator to articulate against 28mm balls of either PyC or CoCr. Each ball was pressed onto the cartilage disk with 40N. In order to allow fluidal load support, the contact migrated over the biphasic cartilage with a 5.2 mm excursion. Concomitantly, the ball oscillated with ±30° at 1 Hz. Testing was conducted for three hours per day over 10 days in Mini ITS medium. Media samples were collected at the end of each three hour test. Upon test commencement, media was pooled (days 1, 4, 7, 10) and analyzed for proteoglycans/sGAGs and hydroxyproline. In addition, total material release into media was estimated by determining the dry weight increase of media samples. For this purpose, 1 ml aliquots of fresh and test media were dialyzed, lyophilized and weighed on a high precision balance. Disk morphology and cell viability were histologically examined.