John B. Medley

Metal on metal total hip replacement workshop consensus document.

The objective of this workshop was to provide a forum to discuss the reintroduction of metal on metal bearings for clinical use in total hip arthroplasty. Approximately 100 researchers clinicians, and industry representatives presented the state of the art interpretation of the metal on metal total hip replacements past performance, and the clinical, tribologic, and biologic considerations of all metal bearings. Based on the scientific presentations at the symposium, the extant literature, the clinical experience of the panelists, and the current regulatory, legal, and economic environment, consensus statements were developed.

Effects of digestion protocols on the isolation and characterization of metal–metal wear particles. I. Analysis of particle size and shape

Isolation of metal wear particles from hip simulator lubricants or tissues surrounding implants is a challenging problem because of small particle size, their tendency to agglomerate, and their potential for chemical degradation by digestion reagents. To provide realistic measurements of size, shape, and composition of metal wear particles, it is important to optimize particle isolation and minimize particle changes due to the effects of the reagents. In this study (Part I of II), transmission electron microscopy (TEM) was used to examine and compare the effects of different isolation protocols, using enzymes or alkaline solutions, on the size and shape of three different types of cobalt-based alloy particles produced from metal-metal bearings. The effect on particle composition was examined in a subsequent study (Part II). Large particles (<1200 nm) were generated by dry abrasion of CoCrMo alloy against itself and small particles (<300 nm) were generated by hip simulator testing of a metal-metal implant pair in the presence of either distilled-deionized water or a 95% bovine serum solution. The reagents changed particle size and to a lesser extent particle shape. For both large particles and small particles generated in water, the changes in size were more extensive after alkaline than after enzymatic protocols and increased with alkaline concentration and time in solution, up to twofold at 2 h and threefold at 48 h. However, when isolating particles from 95% serum, an initial protective effect of serum proteins and/or lipids was observed. Because of this protective effect, there was no significant difference in particle size and shape for both oval and needle-shaped particles after 2 h in 2N KOH and after enzymatic treatments. However, round particles were significantly smaller after 2 h in 2N KOH than after enzymatic treatments. Particle composition may also have been affected by the 2N KOH treatment, as suggested by a difference in particle contrast under TEM, an issue examined in detail in Part II.

Biochemical comparisons of osteoarthritic human synovial fluid with calf sera used in knee simulator wear testing.

Osteoarthritic human synovial fluid was obtained from the knees of 20 patients and was compared with four different calf sera solutions frequently used as lubricants in knee simulator wear testing. Assuming that the fluid after arthroplasty was the same as the fluid in patients with osteoarthritis, the total protein concentration, protein constituent fractions, osmolality, trace element concentrations, and the thermal stability obtained via differential scanning calorimetry were determined. Human synovial fluid, with an average total protein concentration of 34 g/L, was significantly different from all undiluted calf sera. However, alpha-calf serum and iron-supplemented alpha-calf serum were closest in protein constituent fractions (albumin, alpha-1-globulin, alpha-2-globulin, ss-globulin, and gamma-globulin) to human synovial fluid. Diluting calf sera with low-ion distilled water to a total protein concentration of 17 g/L (as recommended by ISO 14243) produced non-clinically relevant total protein concentration and osmolality levels. Performing the same dilution of iron-supplemented alpha-calf serum with phosphate-buffered saline solution and 1.5 g/L hyaluronic acid produced an artificial lubricant with both a clinically relevant level of osmolality and clinically relevant thermal stability as seen in human synovial fluid from patients with osteoarthritis. The present study suggested that alpha-calf serum, phosphate-buffered saline solution and hyaluronic acid were essential constituents of an artificial lubricant to mimic the major biochemical properties of human synovial fluid for simulator wear testing of total knee replacements.

Retrieval analysis of modular total knee replacements: Factors influencing backside surface damage

Retrieved knee implants were examined to investigate the influence of patient and implant related factors on backside damage. Fifty-two implants of three different models were examined that all had cemented tibial trays without screw holes. A semi-quantitative grading system supplied backside damage scores (BDS) for each polyethylene (PE) tibial insert. Evidence was obtained to support the use of a constraining partial-peripheral locking mechanism and polished tibial tray surface (particularly for male patients) to reduce backside damage. Overall, male patients in the present study were associated with higher body mass and higher BDS compared with female patients. Furthermore, PE inserts sterilized by gamma-in-air had higher BDS than PE inserts sterilized in inert environments (gas-plasma or ethylene-oxide). Also, the proximal surfaces of tibial trays that had been grit-blasted showed embedded particles that may have increased backside damage. While none of these overall findings was unexpected, the present study provided detailed supporting analysis based on data from clinical retrievals, which may further support the use of a polished tibial tray combined with partial-peripheral locking mechanism to reduce BDS.

Hydromechanical stimulator for chondrocyte-seeded constructs in articular cartilage tissue engineering applications

Mechanical stimulation is a key technique used for controlling the mechanical properties of tissue engineered articular cartilage constructs proposed for defect repair. The present study introduces a new technical method and device for ‘hydromechanical’ stimulation of tissue engineered articular cartilage constructs. The stimulation consists of simultaneous cyclic compression, frictional shear from a sliding indenter contact and direct pressurized fluid perfusion. Each of these modes of mechanical loading has been shown by other research groups to effectively stimulate tissue engineered constructs. A device for applying these conditions was designed, developed and tested. Two sets (high and low perfusion flow rates) of three experiments were performed, each with two samples subjected to hydromechanical stimulation conditions (compression and friction forces along with perfusion). Two other samples from each set were subjected to just compression and dynamic frictional shear forces, and two more were used as controls (not stimulated). The average amount of glycosaminoglycan retained in the constructs after 3 weeks ranked from low to high as follows: controls, hydromechanical conditions with the low-flow rate, hydromechanical conditions with the high-flow rate and just compression plus dynamic frictional shear. Statistically significant differences were not detected. However, future studies would focus on glycosaminoglycan production in the superficial zone, measuring the glycosaminoglycan released to the nutrient media, and address altering the hydromechanical stimulation parameters using the results of the present study as guidance, in attempts to achieve statistically significant increases in glycosaminoglycan production compared with the controls.

Delamination wear on two retrieved polyethylene inserts after gamma sterilization in nitrogen.

Two self-aligning mobile bearing knee replacements (SAL-1) with gamma-in-nitrogen sterilized polyethylene inserts were revised due to instability after 6.3 years and after 14.2 years in vivo in two patients. The predominant damage features were burnishing, cracking, and delamination and were observed on the proximal bearing surface of the retrieved polyethylene inserts. This suggested an association with sub-surface fatigue, perhaps initiated by in vivo oxidative degradation which was confirmed by developing a sub-surface white band in one insert. The damage features observed on the distal bearing surface of the polyethylene inserts suggested both an adhesive wear mechanism and an abrasive wear mechanism. The titanium-nitrite coated, titanium-alloy tibial tray was severely worn in one case and possibly contributed to third-body abrasive wear at the distal surface interface. We suggest to carefully follow-up patients who received this type of mobile bearing knee system.

Contact analysis of the native radiocapitellar joint compared with axisymmetric and nonaxisymmetric radial head hemiarthroplasty

BACKGROUND Radial head (RH) implants are manufactured from stiff materials, resulting in reduced radiocapitellar contact area that may lead to cartilage degeneration. Although the native RH is nonaxisymmetric, most implants are axisymmetric, potentially contributing to altered contact mechanics. This study compared the joint contact area (Ac) and maximum contact stress (σmax) of axisymmetric and nonaxisymmetric RH implants to the native radiocapitellar joint. METHODS The contact mechanics of intact elbows derived from cadaveric computed tomography data (n = 15) were compared with axisymmetric (size: 18, 20, 22 mm) and nonaxisymmetric (size: 16 × 18, 18 × 20, 20 × 22 mm) RH hemiarthroplasty reconstructed elbows using Abaqus finite element software. Under a 100 N load, Ac and σmax were computed for ±90° pronation-supination and 0°, 45°, 90°, and 135° flexion. RESULTS Compared with native, both hemiarthroplasty models produced significantly lower Ac and higher σmax (P < .001). In the best orientation, the nonaxisymmetric RH provided significantly larger Ac at 0° and 135° flexion (P = .03, P = .007) and reduced levels of σmax at 45° and 90° flexion (P = .003, P < .001). However, there was also a worst orientation that reduced Ac and increased σmax for all flexion angles (P < .003 for all). The native RH was less sensitive to rotation than the nonaxisymmetric RH in terms of σmax (P < .001). The axisymmetric RH was not sensitive to rotation. CONCLUSIONS Whereas a nonaxisymmetric RH can provide improved contact mechanics at certain forearm rotations and flexions, there are also orientations where Ac is reduced and σmax is increased. Axisymmetric designs are more consistent throughout forearm rotation and therefore may be more forgiving than the nonaxisymmetric RH implant design used in this study.

Human corneal epithelial cell response to substrate stiffness

It has been reported that mechanical stimulus can affect cellular behavior. While induced differentiation in stem cells and proliferation and directional migration in fibroblasts are reported as responses to mechanical stimuli, little is known about the response of cells from the cornea. In the present study, we investigated whether changes in substrate stiffness (measured by elastic modulus) affected the behavior of human corneal epithelial cells (HCECs). Polyacrylamide substrates with different elastic moduli (compliant, medium and stiff) were prepared and HCECs were cultured on them. HCECs responses, including cell viability, apoptosis, intercellular adhesion molecule-1 (ICAM-1) expression, integrin-α3β1 expression and changes in cytoskeleton structure (actin fibers) and migratory behavior, were studied. No statistically significant cell activation, as measured by ICAM-1 expression, was observed. However, on compliant substrates, a higher number of cells were found to be apoptotic and disrupted actin fibers were observed. Furthermore, cells displayed a statistically significant lower migration speed on compliant substrates when compared with the stiffer substrates. Thus, corneal epithelial cells respond to changes in substrate stiffness, which may have implications in the understanding and perhaps treatment of corneal diseases, such as keratoconus.

Can physical joint simulators be used to anticipate clinical wear problems of new joint replacement implants prior to market release

One of the most important mandates of physical joint simulators is to provide test results that allow the implant manufacturer to anticipate and perhaps avoid clinical wear problems with their new products. This is best done before market release. This study gives four steps to follow in conducting such wear simulator testing. Two major examples involving hip wear simulators are discussed in which attempts had been made to predict clinical wear performance prior to market release. The second one, involving the DePuy ASR implant systems, is chosen for more extensive treatment by making it an illustrative example to explore whether wear simulator testing can anticipate clinical wear problems. It is concluded that hip wear simulator testing did provide data in the academic literature that indicated some risk of clinical wear problems prior to market release of the ASR implant systems. This supports the idea that physical joint simulators have an important role in the pre-market testing of new joint replacement implants.

Wear simulation strategies for reverse shoulder arthroplasty implants

Reverse total shoulder arthroplasty is a clinically accepted surgical procedure; however, its long-term wear performance is not known. The purpose of this work is to review wear simulator testing of reverse total shoulder arthroplasty, to develop a wear simulator protocol for reverse total shoulder arthroplasty, and to test it by performing a pilot study. The review of wear simulator testing in the literature revealed considerable variation in protocols. A combination of our own cadaveric testing and those of other research groups helped in determining the magnitude and direction of joint loading for the development of the present protocol. A MATCO orbital-bearing simulator was adapted using custom fixtures to simulate a circumduction motion of the shoulder under mildly adverse conditions, and a pilot study gave wear rates within the wide range found in the literature. Arguments were presented in support of the currently developed protocol, but it was also suggested that, rather than rely on one protocol, a series of simulator wear protocols should be developed to fully test the implant wear performance in reverse total shoulder arthroplasty.