Joint Replacement Implants Research Articles

Guidelines for standardization of radiostereometry (RSA) of implants

There is a need for standardization of radiostereometric (RSA) investigations to facilitate comparison of outcome reported from different research groups. In this document, 6 research centers have agreed upon standards for terminology, description and use of RSA arrangement including radiographic set-up and techniques. Consensus regarding minimum requirements for marker stability and scatter, choice of coordinate systems, and preferred way of describing prosthetic micromotion is of special interest. Some notes on data interpretation are also presented. Validation of RSA should be standardized by preparation of protocols for assessment of accuracy and precision. Practical issues related to loading of the joint by weight bearing or other conditions, follow-up intervals, length of follow-up, radiation dose, and the exclusion of patients due to technical errors are considered. Finally, we present a checklist of standardized output that should be included in any clinical RSA paper.This document will form the basis of a detailed standardization protocol under supervision of ISO and the European Standards Working Group on Joint Replacement Implants (CEN/TC 285/WG4). This protocol will facilitate inclusion of RSA in a standard protocol for implant testing before it is released for general use. Such a protocol—also including other recognized clinical outcome parameters—will reduce the risk of implanting potentially inferior prostheses on a large scale.

Biology of alkali- and heat-treated titanium implants.

In cementless fixation systems, surface character is an important factor. Alkali and heat treatments of titanium metal have been shown to produce strong bonding to bone and a higher ongrowth rate. In this study we examined the effect of alkali and heat treatments on titanium rods in an intramedullary rabbit femur model, in regard to the cementless hip stem. The implant rods were 5 mm in diameter and 25 mm in length. Half of the implants were immersed in 5 mol/L sodium hydroxide solution and heated at 600 degrees C for 1 h (AH implants), and the other half were untreated (CL implants). The rods were implanted into the distal femur of the rabbits; AH implants into the left femur and CL implants into the right. The bone-implant interfaces were evaluated at 3, 6, and 12 weeks after implantation. Pull-out tests showed that the AH implants had a significantly higher bonding strength to bone than the CL implants at each time point. As postoperative time elapsed, histological examination revealed that new bone formed on the surface of both types of implants, but significantly more bone made direct contact with the surface of the AH implants. At 12 weeks, approximately 56% of the whole surface of the AH implants was covered with the bone. In conclusion, alkali- and heat-treated titanium offers strong bone bonding and a high affinity to bone as opposed to a conventional mechanical interlocking mechanism. Alkali and heat treatments of titanium may be suitable surface treatments for cementless joint replacement implants.

Synthetic Versus Tissue‐Engineered Implants for Joint Replacement

Human synovial joints are remarkable as they can last for a lifetime. However, they can be affected by disease that may lead to destruction of the joint surface. The most common treatment in the advanced stages of joint disease is artificial joint replacement, where the diseased synovial joint is replaced with an artificial implant made from synthetic materials, such as metals and polymers. A new technique for repairing diseased synovial joints is tissue engineering where cells are used to grow replacement tissue. This paper explores the relative merits of synthetic and tissue‐engineered implants, using joint replacement as an example. Synthetic joint replacement is a well‐established procedure with the advantages of early mobilisation, pain relief and high patient satisfaction. However, synthetic implants are not natural tissues; they can cause adverse reactions to the body and there could be a mismatch in mechanical properties compared to natural tissues. Tissue‐engineered implants offer great potential and have major advantages over synthetic implants as they are natural tissue, which should ensure that they are totally biocompatible, have the correct mechanical properties and integrate well with the existing tissue. However, there are still many limitations to be addressed in tissue engineering such as scaling up for production, bioreactor design, appropriate regulation and the potential for disease to attack the new tissue‐engineered implant.

Strength requirements for internal and external prostheses

Throughout the history of development of joint replacement implants and external prostheses there have been mechanical failures due to a discrepancy between material strength, cross-sectional characteristics and the loads developed in normal or abnormal function by the patient utilising the device. Particularly for internal prostheses attention is being paid at the present time to wear characteristics and the requirements for the articulating surfaces and the volume of wear particles produced during tests simulating the use of the device within the patient. The particular importance of the wear particles is that they seem to be associated with accelerated resorption of bone at areas essential for successful fixation of the implant within it. This article will consider joint replacements at the knee and hip and external prostheses for the leg. If failure due to external trauma is ignored the loads to be considered in testing standards correspond in implants to the muscular and ligamentous forces related to the forces developed between ground and foot and to the bending moments in the structure of leg prostheses. Generally it can be assumed that the treatment of the patient following trauma is more easily accomplished and more likely to be successful if the prosthesis has failed and not the bony structure of the patient. However, the author is unaware that these devices have ever been designed to have lower intrinsic strength than the anatomical structures to which they are connected; indeed in many cases particularly for implants they are much stronger than the bone to which they are connected. The major difficulty in rational design of prosthetic devices has been uncertainty about the importance of occasionally applied loads of a high value relative to those on a frequent basis and also to the frequency of application of these overloads. In this paper consideration is given to methods of determination of load systems relevant to the mechanical performance of implanted joint replacements at the hip and the knee and external prostheses for leg amputees. New data are presented relating to walking, other daily activities and the corresponding frequency of occurrence of these. Loading data on implants obtained by various biomechanical models is compared and related to the loads actually measured by implanted transducers. The philosophy of the standardised test load systems and the performance requirements is reviewed.

Early results with osseointegrated proximal interphalangeal joint prostheses.

Osseointegrated endoprostheses were used in 22 proximal interphalangeal joint replacements in 12 patients between 1993 and 1995. Indications for surgery were joint destruction due to rheumatoid arthritis (13 joints), primary osteoarthrosis (7 joints), posttraumatic arthrosis (1 joint), and psoriatic arthritis (1 joint). The prostheses consisted of 2 screw-shaped titanium fixtures with a flexible silicone spacer. The 1-stage surgical procedure included joint resection and cancellous bone grafting from the iliac crest before insertion of the titanium fixtures. At a follow-up examination 27 months (range, 12-37 months) after surgery, the average active range of motion was 56 degrees (20 degrees to 80 degrees) with an extension lag of 11 degrees (-5 degrees to 45 degrees), corresponding to an average arc of motion of from 11 degrees to 67 degrees flexion. Radiographs indicated that 41 of 44 fixtures were osseointegrated. Four of the 22 joint mechanisms showed fracture of the silicone spacer; deformation of the silicone was noted in an additional 27%. Patient satisfaction was high (20 of 22 joints), with significantly improved range of motion and hand function, increased grip strength, good pain relief, and satisfactory appearance. The results of this study indicate good early clinical findings using osseointegrated implants for proximal interphalangeal joint replacement but also show the need for further development regarding the durability of the flexible silicone joint spacer.

The Control of Mineralization on Natural and Implant Surfaces

AbstractThe generation of minerals such as calcium phosphates on the surfaces of dental and joint replacement implants is beneficial since the facilitation of bone formation permits their fixation. In contrast, the prevention of crystallization is desired on other surfaces such as kidney and cardiac valve prostheses. A key to the development of successful biomaterials is therefore an understanding of the factors that control crystal nucleation, growth and dissolution in aqueous solution. The Constant Composition method was used to investigate the influence of factors such as solution composition, ionic strength, pH and temperature on the crystallization and dissolution of the calcium phosphates, brushite (DCPD), octacalcium phosphate (OCP), hydroxyapatite (HAP) and fluorapatite (FAP). In parallel with these studies, a contact angle method along with surface tension component theory was employed to investigate the roles of interfacial free energy in mineralization and demineralization. Values of the interfacial tensions, -4.2, 4.3, 10.4 and 18.5 mJm-2obtained from contact angle measurements for DCPD, OCP, HAP and FAP, respectively, compare well with those calculated from dissolution kinetics experiments and provide information concerning the growth and dissolution mechanisms. The exploitation of these approaches is illustrated in studies of the coating of specific calcium phosphate phases on titanium metal and alloy surfaces and nucleation and growth of OCP on polymer surfaces modified by silanization to produce amine- and carboxylterminated end groups. In all these reactions involving the calcium phosphates, concomitant dissolution reactions are often involved. Constant Composition kinetic studies have shown that the rate of these reactions decrease markedly with time despite a sustained driving force, and eventually, the rates approach zero even though crystals remain in the undersaturated solutions. Dissolution can be reinitiated by exposing the crystals to the solutions of different undersaturations. These results suggest that dislocation sizes play a significant role in the dissolution kinetic processes.

A Novel Method For Solution Deposition of Hydroxyapatite on to Three Dimensionally Porous Metallic Surfaces: Peri-Apatite Ha

AbstractA method for applying HA coatings to metallic surfaces, without the use of high temperature plasma spraying, has been developed. The HA coating is precipitated in an aqueous solution under conditions similar to those occurring in the body during bone formation. This surface mineralization process results in a coating which is highly crystalline and 100% HA. Processing and characterization experimentation and results are included in the paper.The coating method has the ability to penetrate macroporous (> 100 micron pores) metal structures and coat the undersides and interior surfaces of the areas designed for bone ingrowth on orthopedic devices used for joint replacements. This ability to coat all around a surface is the basis for the name Peri-Apatite HA. Electron microscopy is presented illustrating the coverage and morphology of the coating.The Peri-Apatite HA coating is currently used on both knee joint replacement and hip joint replacement implants.

Polyethylene in total endoprosthetics--a dead end for permanent implants?

Faced with a growing number of younger patients in need of total joint arthroplasty, orthopaedic surgeons are demanding long-term implants for total joint replacement. An assessment of the long-term mechanical behaviour is vivo of all biomaterials in common use in prostheses is in progress. In the present paper, we discuss the long-term reliability of polyethylene (UHMWPE) in joint replacement in terms of tribology and the different biomechanical situation in various human joints. Long-term failure mechanisms for polyethylene in total hip arthoplasty (THA) differ from those seen in total knee arthroplasty (TKA) although the same materials are used. It is thus questionable whether improvements in wear rates of polyethylene in THA would be helpful in TKA.

Mixed‐metal fretting corrosion of Ti6Al4V and wrought cobalt alloy

Corrosion has been reported at the modular interfaces of total joint replacement implants, but with conflicting theories as to the cause of such damage. The modular design itself leaves the interface susceptible to galvanic, crevice, or fretting corrosion, or a combination of the three. The purpose of this study was to quantify the effect of material combination on fretting corrosion of orthopedic alloys. Each test specimen consisted of a two-hole plate with spherical countersinks and two cortical bone screws. The plates and screws were made of either Ti6Al4V or wrought cobalt-chromium-molybdenum (CCM), and were tested in all mixed-metal and similar-alloy combinations. Fretting corrosion experiments were conducted for 14 days in 10% calf serum, according to ASTM F897. Corrosion damage was evaluated by weight-loss measurements, atomic absorption spectrophotometry and scanning electron microscopy analyses. The results indicated that Ti6Al4V suffered relatively severe damage when fretted against itself, as a result of adhesive galling. The extent of titanium damage was reduced considerably, however, when Ti6Al4V was fretted against wrought CCM. In contrast, there was essentially no difference in wrought CCM damage when the alloys was fretted against itself compared to fretting against Ti6Al4V. Finally, in similar-alloy combinations, Ti6Al4V suffered more severe damage than wrought CCM.

Some background theory for the cushion bearing concept in joint replacement implants

The cushion bearing concept has the potential to be a major engineering advance in joint replacement surgery. Essentially, the concept involves the application of elastomeric surface layers in joint replacement implants in order to reduce friction and wear. A numerical solution procedure was applied to analyze the steady-state lubrication of a nominal line contact configuration of infinite width in which the “column model” gave the surface deflection of a compliant layer. High precision formulae for minimum and central film thickness were developed. The analysis was extended to include the influence of curvature on central film thickness and for a typical case it was shown that this influence was negligible. Following the approach of previous researchers, the formula for central film thickness was adapted to apply to an elastic layer with Poisson's ratio of 0.5 and the predictions for film thickness were compared with the results of a study in which numerical solutions were based on a full elasticity model. The agreement between the two approaches was quite good and thus the work of the previous researchers was supported. As a part of this comparison, a formula was developed for central film thickness, using data based on the full elasticity model.

The effects of micromotion and particulate materials on tissue differentiation. Bone chamber studies in rabbits.

Motion at the interface between bone and implants for joint replacement may interfere with osseointegration and prosthesis stabilization. Particulate materials may cause foreign body and chronic inflammatory reactions resulting in bone resorption (osteolysis). The micromotion chamber (MC) and the bone harvest chamber (BHC) were implanted in the rabbit tibia, and the effects of micromotion and phagocytosable particulate materials on tissue formation within the chamber were assessed by studying bone ingrowth into a 1-mm pore. Using the MC, one short daily episode of motion (20 cycles/day, 0.5 mm amplitude) for three weeks decreased the amount of bone ingrowth. Using a different pore configuration, the same parameters of motion increased bone ingrowth. Increasing the amplitude of motion (from 0.5 to 0.75 mm), or the number of daily motion periods (from one to two per day) then decreased bone ingrowth. These studies suggest the existence of a window of externally applied strain: a small stimulus may facilitate and a large stimulus may discourage bone formation within the chamber. Cessation of a given set of motion parameters (producing primarily fibrous tissue) for an additional three weeks was accompanied by tissue differentiation into bone. Using the BHC, small, phagocytosable particles of bone cement, high density polyethylene and cobalt chrome alloy, at a concentration of 1.0 x 10(8) particles/mL, caused a foreign body reaction and inhibited the ingrowth of bone. Particles of titanium alloy had no effect on net bone formation. In studies using normal and immunodeficient rats, T lymphocytes were not a prerequisite for macrophages to phagocytose polyethylene particles. In the clinical situation, micromotion and particulate debris may be synergistic in producing prosthetic loosening. If an implant does not undergo osseointegration due to excessive micromotion, the fibrous tissue interface may provide a conduit for the subsequent migration of particles around the implant.

Chemical and mechanical degradation of UHMWPE: Report of the development of anin vitro test

Ultra high molecular weight polyethylene (UHMWPE), used in total joint replacement implants, undergoes oxidative degradation due to gamma radiation sterilization and to exposure to oxidizing agents in the body environment. UHMWPE components also experience large stresses both on and near the articulating surface. It is hypothesized that there is a causal relationship between chemical degradation and mechanical loading of UHMWPE joint components. This report describes the development of an in vitro test to examine the combined effects of chemical environment and cyclic loading history on the chemical, physical, and mechanical properties of UHMWPE. The test apparatus consists of modular load trains, in which strings of UHMWPE test specimens can be subjected to cyclic tensile and compression load ranges, while being exposed to either control or degrading environments. Following cyclic loading for specified time intervals, the specimens can be statically loaded to determine the effect of cyclic loading and environment on the monotonic tensile and compressive stress–strain behavior of UHMWPE. To determine the appropriate control and degrading environments, gamma radiation sterilized UHMWPE specimens were maintained (unloaded) for up to 6 months in aqueous environments of distilled water and three concentrations of hydrogen peroxide (0.01, 0.1, and 1.0%) in distilled water at 37°C. Specimens were evaluated with depth from the surface for changes in density. Infrared spectroscopy (IR) analysis was conducted on selected surface sections. No significant changes in density or surface IR spectra occurred for specimens in distilled water as compared with the UHMWPE in the initial radiation sterilized condition. Specimens exposed to hydrogen peroxide solutions demonstrated changes in density and IR spectra consistent with oxidative degradation and comparable to the changes previously observed on retrieved UHMWPE components. Based on these results, distilled water was selected for the control environment. A 0.5% hydrogen peroxide solution was selected for the test environment, to produce moderate changes at a rate compatible with the maximum 12-month time period of the experiment. © 1994 John Wiley & Sons, Inc.