Christian Schroeder

Wear of contemporary total knee replacements - A knee simulator study of six current designs

BACKGROUND Compared to conventional ultra-high molecular weight polyethylene (UHMWPE), crosslinked polyethylene showed significantly reduced wear rate in hip simulation and early prospective-randomized clinical studies. The crosslinking process can reduce the mechanical properties of UHMWPE, particularly the fatigue strength. UHMWPE fatigue occurs more frequently in the knee joint than in the hip joint due to its higher contact stresses and there is therefore an increased concern of mechanical failure. Therefore, the purpose of this study was to determine the wear behaviour and the wear rates of different current knee designs and bearing materials. METHODS In a knee-joint-simulator four kinds of crosslinked polyethylene (one produced by sequential irradiation and annealing process, three by different remelting processes, including fixed- and mobile-bearing-types) and two UHMWPE- (fixed- and mobile-bearing) inserts were tested with the appropriate femoral and tibial component recommended from the manufacturer. FINDINGS All types of crosslinked polyethylene produced statistically significant (P<0.05) lower wear rates than the conventional UHMWPEs without any traces of fatigue. There were no differences in the wear rates between fixed-and mobile-bearings (crosslinked polyethylenes and UHMWPEs; P>0.05). The crosslinked polyethylene tibial inserts manufactured by sequential irradiation and annealing (X3) combined with the Scorpio-knee-design had the lowest wear rates (P<0.05) overall. INTERPRETATION Fixed- as well as mobile-bearing crosslinked polyethylene tibial inserts are suitable for total knee arthroplasty and showed reduced wear rates compared with conventional UHMWPE. The combination of the fixed-bearing Scorpio-knee-design with a sequential irradiated and annealed crosslinked polyethylene tibial insert (X3) seems to have an advantage in wear generation compared with other fixed- and mobile-bearing knee designs.

Influence of design and bearing material on polyethylene wear particle generation in total knee replacement

Periprosthetic osteolysis is one of the main reasons for revision of arthroplasty. The osteolytic reaction is influenced by the dose, size and shape of the wear particles. For arthroplasty, a low number and biologically less active particles are required. This is the first study which analyzes the impact of different knee designs, combined with crosslinked polyethylenes (sequentially irradiated and annealed as well as remelted techniques), on the amount, size and shape of particles. Overall, six material combinations, four of them with crosslinked polyethylene (XPE) and two of them with ultra-high molecular weight polyethylene (UHMWPE) inserts, including fixed and mobile bearings, were tested in a knee joint simulator. After isolation nearly 100,000 particles were analyzed in size, shape and number by scanning electron microscopy and image analysis. For all the designs, the wear was predominantly smooth and granular with few fibrillar particles. The Scorpio design with the X3 insert, the Natural Knee II design with the Durasul insert and the LCS design, also combined with a crosslinked polyethylene insert, generated statistically significant (P<0.05) lower particle numbers. The particle size was independent of the radiation dose. The wear generated by the LCS knee design (XPE and UHMWPE) had a higher percentage fraction of particles >1microm in size (equivalent circle diameter). The NexGen design, tested with the Prolong insert, showed a high number of particles in the biologically active size range compared with the other crosslinked designs, which could be a predictor for higher biological reactivity.

Bacterial nanocellulose as a new patch material for closure of ventricular septal defects in a pig model.

OBJECTIVES Current materials for closure of cardiac defects such as ventricular septal defects (VSDs) are associated with compliance mismatch and a chronic inflammatory response. Bacterial nanocellulose (BNC) is a non-degradable biomaterial with promising properties such as high mechanical strength, favourable elasticity and a negligible inflammatory reaction. The aim of this study was the evaluation of a BNC patch for VSD closure and the investigation of its in vivo biocompatibility in a chronic pig model. METHODS Youngs modulus and tensile strength of BNC patches were determined before and after blood exposure. Muscular VSDs were created and closed with a BNC patch on the beating heart in an in vivo pig model. Hearts were explanted after 7, 30 or 90 days. Macropathology, histology and immunohistochemistry were performed. RESULTS Youngs modulus and tensile strength of the BNC patch decreased after blood contact from 6.3 ± 1.9 to 3.86 ± 2.2 MPa (P < 0.01) and 0.33 ± 0.06 to 0.26 ± 0.06 MPa (P < 0.01), respectively, indicating the development of higher elasticity. Muscular VSDs were closed with a BNC patch without residual shunting. After 90 days, a mild chronic inflammatory reaction was present. Moreover, there was reduced tissue overgrowth in comparison with polyester. Proceeding cellular organization characterized by fibromuscular cells, production of extracellular matrix, neoangiogenesis and complete neoendothelialization were found. There were no signs of thrombogenicity. CONCLUSIONS BNC patches can close VSDs with good mid-term results and its biocompatibility can be considered as satisfactory. Its elasticity increases in the presence of blood, which might be advantageous. Therefore, it has potential to be used as an alternative patch material in congenital heart disease.

Biotribology of a mobile bearing posterior stabilised knee design--effect of motion restraint on wear, tibio-femoral kinematics and particles.

The objective of our study was to evaluate the impact of a biphaseal anterior-posterior (AP) and internal-external (IE) motion restraint system on the wear behaviour, tibio-femoral kinematics and particle release of a mobile bearing posterior stabilised knee design in comparison to the widely used linear restraint. in vitro wear simulation was performed using a posterior stabilised total knee replacement with a mobile rotating platform gliding surface design to compare the standard ISO 14243-1:2002 (E) protocol with a linear AP and IE motion restraint and the new ISO 14243-1:2009 (E) protocol with a biphaseal AP and IE motion restraint. For the mobile gliding surfaces, an increase in wear rate by more than a magnitude was measured applying the biphaseal protocol (8.5±1.6 mg/million cycles) in a direct comparison to the linear protocol (0.33±0.07 mg/million cycles), with statistically significant difference. The amplitudes of AP displacement were 3.22±0.47 mm for the biphaseal test, compared to 1.97±0.22 mm in the linear test and the amplitudes of the IE rotation angle had mean values of 7.32°±0.91° under the biphaseal setup, compared to 1.97°±0.14° under linear motion restraint test conditions. From our observations, we conclude that the changes in AP translation and IE rotation motion restraints from ISO linear to ISO biphaseal test conditions highly impact the knee joint kinematics and wear behaviour of a mobile bearing posterior stabilised knee design.

Primary stability of tibial plateaus under dynamic compression-shear loading in human tibiae – Influence of keel length, cementation area and tibial stem

The objective of our study was to evaluate the impact of the tibial keel & stem length in surface cementation, of a full cemented keel and of an additional tibial stem on the primary stability of a posterior stabilised tibial plateau (VEGA® System Aesculap Tuttlingen, Germany) under dynamic compression-shear loading conditions in human tibiae. We performed the cemented tibial plateau implantations on 24 fresh-frozen human tibiae of a mean donor age of 70.7years (range 47-97). The tibiae were divided into four groups of matched pairs based on comparable trabecular bone mineral density. To assess the primary stability under dynamic compression shear conditions, a 3D migration analysis of the tibial component relative to the bone based on displacements and deformations and an evaluation of the cement layer including penetration was performed by CT-based 3D segmentation. Within the tested implant fixation principles the mean load to failure of a 28mm keel and a 12mm stem (40mm) was 4700±1149N and of a 28mm keel length was 4560±1429N (p=0.996), whereas the mean load to failure was 4920±691N in full cementation (p=0.986) and 5580±502N with additional stem (p=0.537), with no significant differences regarding the dynamic primary stability under dynamic compression-shear test conditions. From our observations, we conclude that there is no significant difference between a 40mm and a 28mm tibial keel & stem length and also between a surface and a full cementation in the effect on the primary stability of a posterior stabilised tibial plateau, in terms of failure load, migration characteristics and cement layer thickness including the penetration into the trabecular bone.