Method

For the first time a novel design has been used to isolate the taper junction on modular devices on the hip simulators in order to compare the wear at the taper junction and articulating surface. The taper junction has been isolated in a small gaiter, while the head and cup were contained in a large gaiter. CoCrMo sleeves having an offset of +8 mm have been used on 50 mm modular heads along with Ti6Al4V stems. The acetabular components were standard BHR cups. Three devices (Smith & Nephew, UK) have been tested with newborn calf serum as a lubricant (in the large gaiter) and also as the medium containing the taper junction (in the small gaiter). The serum samples from the articulating surface and taper junction were analysed using HR-ICPMS. The locking interfaces at the taper junction have been left intact throughout the duration of the test. Both the head and the cup have been tested under anatomical conditions using the standard implant development centre's (IDC) profile for 2 million cycles (Mc). The lubricant was newborn calf serum with 0.2% sodium azide diluted with de-ionised water to achieve protein concentration of 20 mg/ml. The flexion/extension was 30°/15° and the internal/external rotation was ±10°. The force was Paul-type stance phase loading with a maximum load of 3 kN and a standard ISO swing phase load of 0.3 kN. The frequency was 1 Hz, with an 8 hour stop after every 16 hours of testing.

Materials & Methods

Two groups of 44 mm MoM devices were tested, n=3 in each group. The devices were subjected to 1 and 2 mm of subluxation. The flexion/extension was 30° and 15° respectively, internal/external rotation was ±10°, and cup inclination was 35°. The force was Paul type stance phase loading with a maximum load of 3 kN, with ISO swing phase load of 0.3 kN, run at 1 Hz.

The test was carried out on a ProSim deep flexion & subluxation hip wear simulator (SimSol, UK). Rather than separating the head and the cup (microseparation), or reducing the swing phase load, this simulator is equipped with a novel mechanism to achieve translation of the head, while subjecting the devices to subluxation. During the swing phase, a controlled lateral force necessary for the translation of the head is applied by a cam mechanism, head retraction will then take place on heel strike.

The lubricant used was new born calf serum with 0.2 wt. % sodium azide concentration diluted with de-ionised water to achieve average protein concentration of 20 g/l. Lubricant was changed every 250k cycles. Gravimetric wear measurements have been taken at 0.25 & 0.5 Mc stages.

Results

Tests conducted with 1mm (Group 1) and 2mm (Group 2) subluxation significantly increased volumetric wear compared to standard hip simulator tests [1]. At 0.5 million cycles, group 1 and 2 produced an average volume loss of 4.38±0.98 mm³ (95% CL) and 7.07±1.64 mm³ (95% CL) respectively.

Materials & Methods

Three pairs of 50mm as cast (AC) and four pairs of 50mm double heat treated (DHT) CoCr MoM devices were tested in a ProSim hip simulator. In order to determine the frequency for testing, Patients' activities have been monitored using a Step Activity Monitor (SAM) device. The data showed a relatively slower walking pace (frequency) than that used in the hip simulator studies. The new frequency, along with stop/start motion and various kinetics and kinematics profiles have been used in putting together a more physiologically relevant hip simulator test protocol. The lubricant used in this study was new born calf serum with 0.2 % (w/v) sodium azide concentration diluted with de-ionised water to achieve an average protein concentration of 20 g/l. Gravimetric measurements have been taken at 0.5, 1, 1.5 & 2 million cycle (Mc) stages and ion analysis has been carried out on the serum samples.