5.1 This test procedure provides a method of evaluating the frictional torque and friction factor of hip replacement bearings.5.2 The procedure may be used as a standardized method of measuring friction to investigate the effects of specific test parameters such as hip materials, sizes, designs, radial or diametral clearance, different lubricants, different deformation levels of the acetabular cup, clamping (non-uniform sphericity), damaged/scratched bearings, artificial ageing, misalignments during installation, etc.5.3 Friction torque, and in particular the maximum value, is useful to assess the applicable torques that may compromise fixation, or even risk disassociation of modular components in the acetabular cup or liner/shell assemblies through a lever-out or torsion-out mechanism.5.4 Friction factor is a useful parameter for comparison of materials and designs, and provides insights into the lubrication regime operating in the implant system. Friction factor measurement may also be able to detect acetabular liner deformation (clamping referred to earlier).5.5 The loading and motion of a hip replacement in vivo differ from the loading and the motion defined in this standard. The amount of frictional forces in vivo will, in general, differ from the frictional forces evaluated by this standard test method. The results obtained from this test method cannot be used to directly predict in vivo performance. However, this standard is designed to allow for in-vitro comparisons for different hip designs, when tested under similar conditions.5.6 Although this test method can be used to investigate the many variables listed in 1.2 and 5.2, it does not either provide a method to determine beforehand the combination of these variables that will produce the worst-case couple(s) among a range of sizes; the worst-case testing condition(s) for “normal” or “adverse” conditions; or provide specific methods to deform the acetabular cup, simulate Mode 3 wear conditions (for example, third-body particles, scratched heads), or artificially aged materials. As these methods are not included in the standard and if they are to become the subject of the investigation then it is up to the user to justify the couple(s) selected and method(s) used in the test and, if necessary, provide a rationale for how the “worst-case” couple(s) and method(s) were selected to represent clinically relevant “normal” and “adverse” conditions as part of the report.1.1 This test procedure provides a method of determining the frictional torque and friction factor of artificial hip joint bearings used in total hip replacement (THR) systems under laboratory conditions using a reciprocal friction simulator. This test method specifies the angular movement between the articulating components, the pattern of applied force, and the way data can be measured and analyzed.1.2 Many variables can be investigated using this test method including, but not limited to, the effect of head size, different inclination/version angles, different deformation levels of the acetabular cup, bearing clearances, lubrication, scratched heads, and artificial ageing.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 This test procedure provides a method of evaluating the frictional torque and friction factor of artificial hip joint bearings under the stated in-vitro test conditions.5.2 Friction is not simply a materials property. The specimen system and the effects on its friction are multi-factorial, including the materials and processing of the components, the design and assembly of the components, the test parameters, and environmental factors (lubricant, temperature, etc.).5.3 The procedure may be used as a standardized method of measuring friction for a particular system, or as a method of investigating the effects of specific test parameters such as hip sizes, designs, radial clearance, different lubricants, clamping (nonuniform sphericity), misalignments during installation, etc.5.4 The procedure may be used to study the variation of friction with time as the specimens wear, which is particularly useful for samples that undergo a transition from “run-in” to “steady-state” wear behavior. Since the motion and load waveforms are identical to those specified in ISO 14242-1:2014, standardized friction and wear measurements may be combined and viewed in the correct perspective where they affect each other.5.5 Frictional torque, and in particular the maximum value, are useful to assess the torques that may compromise fixation, or cause disassociation of modular components in acetabular cup or liner/shell assemblies through a lever-out or torsion-out mechanism.5.6 Friction factor is a useful parameter for comparison of materials and designs, and provides insights into the lubrication regime operating in the implant system. Friction factor measurement may also be able to detect acetabular liner deformation (clamping referred to earlier).1.1 This test procedure provides a method of evaluating the frictional torque and friction factor of artificial hip joint bearings used in Total Hip Replacement systems. The method presented here was based on a published study, first as a conference paper in 2008 (1)2 and then as a peer-reviewed journal paper (2). The method is compatible with and is capable of being carried out during actual wear testing of total hip replacement implants on wear simulators equipped with multiple degrees of freedom force and moment sensors.1.2 Although the methodology described does not replicate all physiological loading conditions, it is a means of in-vitro comparison of the frictional torque and friction factor of artificial hip joint bearings used in Total Hip Replacement systems under the stated test conditions.1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 Approximately 500 000 primary total hip arthroplasties (THAs) and 66 000 revision THAs are predicted to be performed in the United States in 2020 (7). There are an estimated 340 000 hip fractures per year in the United States (8).1.1 This guide is intended as a resource for individuals and organizations when designing clinical trials and/or clinical registries and addresses the selection of patient-reported outcomes, safety outcomes, imaging outcomes, and other topics related to hip reconstructive surgery (HRS) including: (1) hip replacement systems, (2) hip fracture surgery, (3) acetabular fracture surgery, (4) hip arthroscopy and/or labrum repairs, and (5) peri-acetabular osteotomies, or other hip surgeries.1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of HRS devices through standardizing clinical outcome measures are provided for designing, reviewing, and accepting human clinical trial protocols.1.3 This guide is intended to provide consistency in study design, review, regulatory approval, and health insurance coverage approval for hip reconstructive surgery to the health care market.1.4 For the purpose of this guide, HRS pertains to any device or tissue-engineered medical product (TEMP) that is intended to replace, resurface, reconstruct, and/or provide fixation of the hip joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term improvement in function and pain relief without major adverse events are the desired outcomes.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 This practice can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic femoral hip prostheses subject to cyclic loading for large numbers of cycles.4.2 The loading of femoral hip designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic femoral hip designs when tested under similar conditions.4.3 In order for fatigue data on femoral hip prostheses to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.1.1 This practice covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip prostheses that utilize proximal metaphyseal fixation and are of a modular construct, and it is intended to evaluate the fatigue performance of the modular connections in the metaphyseal filling (that is, proximal body) region of the stem.1.2 This practice is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic hip prostheses while held in a proximally fixated manner, with the distal end not held by a potting medium.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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3.1 This guide uses a weight-loss method of wear determination for the polymeric components used with hip joint prostheses, using serum or demonstrated equivalent fluid for lubrication, and running under a dynamic load profile representative of the human hip-joint forces during walking (1,2).5 The basis for this weight-loss method for wear measurement was originally developed (3) for pin-on-disk wear studies (see Practice F732) and has been extended to total hip replacements (4,5) femoral-tibial knee prostheses (6), and to femoropatellar knee prostheses (6,7).3.2 While wear results in a change in the physical dimensions of the specimen, it is distinct from dimensional changes due to creep or plastic deformation, in that wear generally results in the removal of material in the form of polymeric debris particles, causing a loss in weight of the specimen.3.3 This guide for measuring wear of the polymeric component is suitable for various simulator devices. These techniques can be used with metal, ceramic, carbon, polymeric, and composite counter faces bearing against a polymeric material (for example, polyethylene, polyacetal, and so forth). This weight-loss method, therefore, has universal application for wear studies of total hip replacements that feature polymeric bearings. This weight-loss method has not been validated for high-density material bearing systems, such as metal-metal, carbon-carbon, or ceramic-ceramic. Progressive wear of such rigid bearing combinations generally has been monitored using a linear, variable-displacement transducers or by other profilometric techniques.1.1 This guide describes a laboratory method using a weight-loss technique for evaluating the wear properties of materials or devices, or both, which are being considered for use as bearing surfaces of human-hip-joint replacement prostheses. The hip prostheses are evaluated in a device intended to simulate the tribological conditions encountered in the human hip joint, for example, use of a fluid such as bovine serum, or equivalent pseudosynovial fluid shown to simulate similar wear mechanisms and debris generation as found in vivo, and test frequencies of 1 Hz or less.1.2 Since the hip simulator method permits the use of actual implant designs, materials, and physiological load/motion combinations, it can represent a more physiological simulation than basic wear-screening tests, such as pin-on-disk (see Practice F732) or ring-on-disk (see ISO 6474).1.3 It is the intent of this guide to rank the combination of implant designs and materials with regard to material wear-rates, under simulated physiological conditions. It must be recognized, however, that there are many possible variations in the in vivo conditions, a single laboratory simulation with a fixed set of parameters may not be universally representative.1.4 The reference materials for the comparative evaluation of candidate materials, new devices, or components, or a combination thereof, shall be the wear rate of extruded or compression-molded, ultra-high molecular weight (UHMW) polyethylene (see Specification F648) bearing against standard counter faces [stainless steel (see Specification F138); cobalt-chromium-molybdenum alloy (see Specification F75); thermomechanically processed cobalt chrome (see Specification F799); alumina ceramic (see Specification F603)], having typical prosthetic quality, surface finish, and geometry similar to those with established clinical history. These reference materials will be tested under the same wear conditions as the candidate materials.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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This practice can be used to describe the effects of materials, manufacturing, and design variables on the fatigue resistance of metallic stemmed femoral components subjected to cyclic loading for relatively large numbers of cycles. The recommended test assumes a “worst case” situation where proximal support for the stem has been lost. It is also recognized that for some materials the environment may have an effect on the response to cyclic loading. The test environment used and the rationale for the choice of that environment should be described in the report. It is recognized that actual in vivo loading conditions are not ofconstant amplitude. However, there is not sufficient information available to create standard load spectrums for metallic stemmed femoral components. Accordingly, a simple periodic constant amplitude force is recommended. In order for fatigue data on femoral stems to be useful for comparison, it must be reproducible among different laboratories. Consequently, it is essential that uniform procedures be established.1.1 This practice describes a method for the fatigue testing of metallic stemmed femoral components used in hip arthroplasty. The described method is intended to be used to evaluate the comparison of various designs and materials used for stemmed femoral components used in the arthroplasty. This practice covers procedures for the performance of fatigue tests using (as a forcing function) a periodic constant amplitude force. 1.2 This practice applies primarily to one-piece prostheses and modular components, with head in place such that prostheses should not have an anterior/posterior bow, and should have a nearly straight section on the distal 50 mm of the stem. This practice may require modifications to accommodate other femoral stem designs. 1.3 The values stated in SI units are to be regarded as the standard. 1.4 For additional information see Refs. (1-5) .

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This specification covers the design and dimensional requirements for metallic, ceramic, and polymeric mating bearing surfaces used in total hip joint prostheses and hip endoprostheses, more specifically, hip joint replacements of the ball-and-socket configuration. This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the following: spherical articulating metallic or ceramic femoral heads of total hip joint prostheses; spherical concave mating surface of metallic and ceramic acetabular components, including the inner polymeric bearing surface of bipolar heads; spherical concave mating surface of polymeric acetabular components; and spherical metallic or ceramic femoral heads of hip endoprostheses, and the outer bearing surface of bipolar heads. This specification, however, does not address the tolerance match between the mating bearing surfaces.1.1 This specification covers the requirements for the mating bearing surfaces of total hip joint prostheses or resurfacing hip devices, intended for total hip arthroplasty; and hip endoprostheses, intended for hemiarthroplasty. More specifically, this specification covers hip joint replacement of the ball-and-socket configuration.1.2 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical articulating metallic or ceramic femoral heads of total hip joint prostheses.1.3 This specification covers the sphericity, and surface finish requirements for the spherical concave mating surface of metallic and ceramic acetabular components, and the surface finish requirements and dimensional tolerances for the spherical concave mating surface of polymeric acetabular components.1.4 This specification covers the sphericity, surface finish requirements, and dimensional tolerances for the spherical metallic or ceramic femoral heads of hip endoprostheses.1.5 This specification covers the surface finish requirements and dimensional tolerances for the inner polymeric bearing surface of bipolar hip components, and the sphericity and surface finish requirements of the inner metallic or ceramic bearing surface of bipolar hip components; and the sphericity, surface finish requirements, and dimensional tolerances of outer metallic or ceramic bearing surfaces of bipolar hip components of hip endoprostheses.1.6 This specification is intended for standard practice regarding the design of total hip joint bearing surfaces. Additionally, the tolerances imposed on the polymeric portion of the bearing surface are intentionally large due to temperature-induced size changes and other manufacturing concerns. Some manufacturing methods or designs may intentionally reduce the diameter of the polymeric bearing to more closely mate with the diameter of the head.1.7 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 This test method should be used to evaluate and compare different femoral and acetabular prosthesis designs to assess the damage tolerance under controlled laboratory conditions.5.2 Although the methodology described attempts to identify physiologically relevant motions and loading conditions, the interpretation of results is limited to an in-vitro comparison between different femoral and acetabular prosthesis designs regarding their ability to resist impingement damage modes (defined in 8.2) under the stated test conditions.1.1 This test method covers a procedure to simulate dynamic impingement between femoral and acetabular components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined in 8.2); and, if necessary, quantitative assessment of changes in modular component attachment strength.1.2 This test method can be used to evaluate impingement between femoral components and the following: single-piece, modular, semi-constrained, bipolar, constrained, or dual mobility acetabular components, manufactured from polymeric, metallic, or ceramic materials.1.3 The values stated in SI units are regarded as the standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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3.1 This practice is applicable to the calculation of stresses seen on a femoral hip stem when loaded in a manner described in ISO 7206-4 (2010). This method can be used to establish the worst-case size for a particular implant. When stresses calculated using this practice were compared to the stresses measured from physical strain gauging techniques performed at two laboratories using two different methods, the results correlated to within 8 %.3.2 This test method can be used to estimate the effects of design variables on the stress and strain of metallic hip femoral stems in a set-up mimicking that described in ISO 7206-4 (2010).1.1 This practice establishes requirements and considerations for the numerical simulation of non-modular (that is, limited to monolithic stems with only a femoral head/trunnion taper interface) metallic orthopaedic hip stems using Finite Element Analysis (FEA) techniques for the estimation of stresses and strains. This standard is only applicable to stresses below the yield strength, as provided in the material certification.1.2 Purpose—This practice establishes requirements and considerations for the development of finite element models to be used in the evaluation of non-modular metallic orthopaedic hip stem designs for the purpose of prediction of the static implant stresses and strains. This procedure can be used for worst-case assessment within a series of different sizes of the same implant design to reduce the physical test burden. Recommended procedures for performing model checks and verification are provided to help determine if the analysis follows recommended guidelines. Finally, the recommended content of an engineering report covering the mechanical simulation is presented.1.3 Limits—This practice is limited in discussion to the static structural analysis of non-modular metallic orthopaedic hip stems (which excludes the prediction of fatigue strength).1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 Magnetic resonance imaging is ideally suited to image MOM hip arthroplasty due to its superior soft tissue contrast, multiplanar capabilities and lack of ionizing radiation. MR imaging is the most accurate imaging modality for the assessment of peri-prosthetic osteolysis and wear-induced synovitis (19, 20).5.2 Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant.5.3 This guide can be used to identify the following adverse events.5.3.1 Osteolysis—Magnetic resonance imaging is superior to conventional radiographs and computer tomography (CT) in the assessment of peri-prosthetic osteolysis and has been shown to be the most accurate method to locate and quantify the extent of peri-prosthetic osteolysis (19, 21). On MR imaging, osteolysis appears as well marginated intraosseous intermediate to slightly increased signal intensity lesions that contrast with the high signal intensity of the intramedullary fat. A characteristic line of low signal intensity surrounds the area of focal marrow replacement, distinguishing the appearance of osteolysis from tumoral replacement of bone or infection (22).FIG. 4 Coronal (left) and Axial (right) FSE Images of a Left MOM Hip ArthroplastyNOTE 1: There is focal osteolysis (white arrows) in the greater trochanter, which manifests as well-demarcated intermediate signal intensity, similar to that of skeletal muscle, replacing the normal high signal intensity fatty marrow. Images courtesy of Dr. Hollis Potter.5.3.2 Component Loosening—While the data are preliminary, MR imaging can identify circumferential bone resorption that may indicate component loosening. Loosening may result from osteolysis, circumferential fibrous membrane formation or poor osseous integration of a non-cemented component. On MR imaging, component loosening typically manifests as circumferential increased signal intensity at the metallic-bone or cement-bone interface on fat-suppressed techniques (20). The finding of circumferential fibrous membrane formation or osteolysis also indicates potential loosening; this is in contrast to a well-fixed component, with high signal intensity fatty marrow directly opposed to the implant interface.5.3.3 Wear-Induced Synovitis—Magnetic resonance imaging is the most useful imaging modality to assess the intracapsular burden of wear-induced synovitis surrounding MOM arthroplasty (23). Preliminary data indicate that the signal characteristics of the synovial response on MR imaging correlate with the type of wear-induced synovitis demonstrated on histology at revision surgery (24). Low signal intensity debris is suggestive of metallic debris on histology. Mixed intermediate and low signal debris correlate with the presence of mixed polymeric (polyethylene and/or polymethyl methacrylate) and metallic debris at histology. Magnetic resonance imaging can demonstrate decompression of synovitis or fluid into adjacent bursae, such as the iliopsoas or trochanteric bursa, which can present as soft tissue masses or with secondary nerve compression. On occasion, wear-induced synovitis can result in a chronic indolent pattern of erosion of the surrounding bone, even in the absence of focal osteolytic lesions (6).FIG. 5 Axial (left) and Coronal (right) FSE Images of a Left MOM Hip ArthroplastyNOTE 1: Wear-induced synovitis decompresses into the abductor musculature where there is low signal intensity debris (arrow), consistent with metallic debris. Images courtesy of Dr. Hollis Potter.5.3.4 Infection—In the setting of infection, the synovium often demonstrates a hyperintense, lamellated appearance with adjacent extracapsular soft tissue edema. These appearances help to distinguish the synovial pattern of infection from wear-induced synovitis, although aspiration is still required for definitive diagnosis (22). The presence of a soft tissue collection, draining sinus or osteomyelitis further supports the diagnosis of infection on MR imaging.FIG. 6 Axial FSE (left) and Inversion Recovery (right) Images of a Right MOM Hip AthroplastyNOTE 1: There is a lamellated synovitis (black arrow) with adjacent extracapsular soft tissue edema (white arrow). Infection was confirmed at subsequent aspiration. Images courtesy of Dr. Hollis Potter.5.3.5 Adverse Local Tissue Response—Adverse local tissue reactions can manifest as synovitis, bursitis, osteolysis and cystic or solid masses adjacent to the arthroplasty, which may be termed pseudotumors (19, 20). ALTR can also include the histopathologic feature of aseptic lymphocytic vasculitis-associated lesions (ALVAL), which can be confirmed at histology. A relatively common appearance of joints with ALVAL is expansion of the capsule with homogenous high signal fluid interspersed with intermediate signal intensity foci. More recent studies suggest that maximum synovial thickness and the presence of more solid synovial deposits highly correlate with tissue damage at revision surgery and necrosis at histologic inspection (15).FIG. 7 Axial FSE Image in a Right MOM Hip ArthroplastyNOTE 1: Fig. 7 demonstrates a large collection of fluid in the trochanteric bursa (arrow), which communicates with the hip joint via a dehiscence in the posterior pseudocapsule (not shown in these images). The fluid is high signal with fine intermediate signal intensity debris. A high ALVAL score was confirmed on histology at revision surgery. Images courtesy of Dr. Hollis Potter.FIG. 8 Axial FSE Image in a Right MOM Hip Resurfacing ArthroplastyNOTE 1: Fig. 8 demonstrates expansion of the pseudocapsule with fluid signal intensity decompressing into the trochanteric bursa. The pseudocapsule is thickened and of intermediate signal intensity (black arrows). There is additional solid extracapsular disease anteriorly (white arrow). At revision surgery, a mixed picture of ALVAL and metallosis was seen.5.3.6 Modular Taper Associated ALTR—MRI can accurately describe ALTR attributed to tribocorrosion in modular femoral neck total hip arthroplasty. MRI characteristics, particularly maximal synovial thickness and synovitis volume, can predict histologic severity (22, 23). In addition, intra-capsular ALTR around either resurfacing MOM arthroplasty or around the trunnion in MOM THA may be obscured if 3D-MSI techniques are not utilized due to the susceptibility artifact. High-bandwidth FSE or FSE with view-angle tilt are not sufficient.NOTE 1: Modular taper ALTR may occur in non-metal-on-metal implants as well as in metal-on-metal arthroplasty.1.1 This guide describes the recommended protocol for magnetic resonance imaging (MRI) studies of patients implanted with metal-on-metal (MOM) devices to determine if the periprosthetic tissues are likely to be associated with an adverse local tissue reaction (ALTR). Before scanning a patient with a specific implant, the MR practitioner shall confirm that the device is MR Conditional and that the scan protocol to be used satisfies the conditions for safe scanning for the specific implant. This guide assumes that the MRI protocol will be applied to MOM devices while they are implanted inside the body. It is also expected that standardized MRI safety measures will be followed during the performance of this scan protocol.1.2 This guide covers the clinical evaluation of the tissues surrounding MOM hip replacement devices in patients using MRI. This guide is applicable to both total and resurfacing MOM hip systems.1.3 The protocol contained in this guide applies to whole body magnetic resonance equipment, as defined in section 201.3.239 of IEC 60601-2-33, Ed. 3.2, with a whole body radiofrequency (RF) transmit coil as defined in section 201.3.240. The RF coil should have circulary polarized RF excitation (also commonly referred to as quadrature excitation) as defined in section 201.3.249 of IEC 60601-2-33, Ed. 3.2..1.4 The values stated in SI units are to be regarded as standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. The user may consider all precautions and warnings provided in the MR system and hip implant labeling prior to determining the applicability of these protocols.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1.1 This standard guide provides options and a compendium of information for measuring the bearing surface and estimating the in-vivo wear of explanted Metal-on-Metal (MoM) and other “hard” (for example, ceramic) hip components. The guide covers the measurement of acetabular cups and femoral heads using a dimensional change method and is applicable to all prosthetic hip types, including stemmed (modular) and resurfacing hip systems.1.2 The methods specified in this guide are not applicable for measuring the in-vivo wear from non-articulating surfaces, for example modular connections (at the stem/neck, neck/head, or cup liner/shell interface) or at the acetabular cup rim.1.3 The parameters (wear depth and volumetric wear) evaluated and reported in this guide are estimated from the assumed as-manufactured shape of the components. The wear volume is calculated using a numerical integration method and the wear depth is the difference between the assumed as-manufactured shape and the measured surface.1.4 This guide covers the measurement of the depth of wear and the volumetric wear using a Coordinate Measuring Machine (CMM) and the depth of wear using an Roundness Machine. Other metrology measurement equipment may be used to measure the wear depth or volume if the resolution and accuracy of the measurements are comparable with the instruments detailed in this standard. The measurement and analysis protocols should be based on those described in this standard.1.5 This guide is applicable to hip joints which are nominally spherical at the time of manufacture. Form deviations resulting from manufacturing or deformation may occur and may necessitate the use of a non-spherical surface to represent the unworn surface of the component. Hip joints designed with asymmetry are considered beyond the scope of this guide, although the principles and techniques may be applicable to the characterization of wear from the articulating surfaces.1.6 This guide is intended as an extension to Practice F561 as a Stage II nondestructive test.1.7 This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices should be sterilized or disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be the subject of subsequent analysis. A detailed discussion of precautions to be used in handling human tissues can be found in ISO 12891-1. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 This practice uses clinical radiographs of the hip joint of a patient that has received a total hip replacement to measure the combined effect of plastic deformation and wear at the articular interface which results in three-dimensional displacements of the femoral head into the acetabular component.4.2 This practice addresses the validation of the various computational methods available for measuring the magnitude of creep/wear accruing at the articular surface of THRs.4.3 This practice addresses the type of radiographic projections needed for an analysis as well as general radiographic parameters needed for obtaining high quality films.4.4 This practice addresses the criterion for evaluating clinical radiographs for inclusion in a study.4.5 This practice addresses the conversion of radiographic images to the appropriate digital format needed for the various computer-assisted computational methods.1.1 This practice provides guidance for the measurement of the relative displacement of the femoral head and acetabular component that result from wear and deformation occurring at the articular interface of a total hip replacement from sequential clinical radiographs.1.2 This practice is primarily intended for use in evaluating patients receiving THRs composed of a polyethylene acetabular component articulating against a metal or ceramic femoral head.1.3 So-called hard-on-hard articulations such as metal-on-metal and ceramic-on-ceramic THRs are not intended to be directly addressed.1.4 This practice will focus on computer-assisted computational methodologies for measuring relative displacements over time but not to the exclusion of other methodologies.1.5 This practice describes methods for conducting a radiographic wear/creep study utilizing various computational methods and is not intended to promote or endorse a particular method.1.6 It is not the intent of this practice to provide detailed instructions in the use of the various computational methods, which is contained in the respective user manuals.1.7 It is the intent of this practice to enable comparisons of relative displacements occurring in groups of patients receiving different formulations of bearing materials. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single clinical study may not be universally representative.1.8 This practice is not intended to be a performance standard. It is the responsibility of the user of this practice to characterize the safety and effectiveness of the prosthesis under evaluation.1.9 The values stated in SI units are to be regarded as the standard, with the exception of angular measurements, which may be reported in either degrees or radians. Additionally, pixel density may also be reported in imperial units.1.10 The use of this standard may involve the operation of potentially hazardous radiographic equipment and does not purport to address the safety precautions associated with radiography. It is the responsibility of the user of this standard to define and establish appropriate safety practices. The standard does not determine the applicability of regulatory limitations prior to operating radiographic equipment.1.11 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.12 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip and modular knee components.4.2 Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs.4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.4.4 Tests that are checked in Table 1, Table 2, or Table 3 or indicated in this guide as a possible test to consider may not be applicable to every implant design.1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.1.2 This guide does not attempt to define all test methods associated with modular device evaluation.1.3 The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 HIP of castings should be performed in the as cast condition. Post HIP inspection of castings should result in a reduction of porosity that is evident in x-ray grade and properties.4.2 HIP will not eliminate inclusions or surface-connected porosity in a casting.1.1 This guide presents requirements for hot isostatic pressing (HIP) of aluminum alloy castings. HIPing is a process in which components are subjected to the simultaneous application of heat and high pressure in an inert gas medium. The process is to be used for the reduction of internal (non-surface connected) porosity. The document is to describe the general parameters of the HIP process, describe certification procedures and a description that the process has been followed. It is not intended to be a description of a heat treating procedure. This is not meant to supersede an end user’s specification where one exists.21.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 This document provides guidance for a range of assessments and evaluations to aid in preclinical research and device development of hard-on-hard total hip replacement and hip resurfacing devices used for the repair of musculoskeletal disorders.4.2 The user is encouraged to use appropriate ASTM International or ISO standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on alloy fabricated forms, ceramic material samples, device components, or devices before assessment in an in vitro model.4.3 Studies to support regulatory submissions should conform to appropriate regulatory requirements and guidelines for the development of medical devices.4.4 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on hard-on-hard hip prosthesis components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to clinical conditions. Referenced metal-onmetal or ceramic-on-ceramic hip prosthesis publications can be found in the Bibliography section at the end of this guide for further review.1.1 This guide covers materials and design recommendations and general test methods for the chemical, mechanical, and preclinical assessment of implantable devices with hard-on-hard articulations intended to replace a hip joint. The provided guidance is intended to encompass both Total Hip Replacement (THR) devices with stems that extend or fix within the intramedullary canal as well as Hip Resurfacing Arthroplasty (HRA) wherein only the hip articulating surfaces are replaced. There has been long term clinical experience with metal-on-metal articulating components manufactured from cobalt-28 % chromium-6 % molybdenum (Co28Cr6Mo) alloy (Specifications F75, F799, or F1537) or high purity alumina (ISO 6474-1) and ceramic-on-ceramic articulating components manufactured from high purity alumina (ISO 6474-1) or alumina matrix composite ceramics (ISO 6474-2). There has also been some limited clinical experience with metal (Co28Cr6Mo) on alumina matrix composite ceramic articulating components. This guide has been created based on the current understanding derived from those clinical histories. Device articulating components manufactured from other metallic alloys, ceramics or with coated or elementally modified articulating surfaces could also be evaluated with this guide. However, such materials that do not have a history of clinical use may present different risks.1.2 This guide applies to the acetabular and femoral articulating components of hard-on-hard hip replacement devices. Acetabular components can be monoblock, or a modular component with a separate acetabular shell and acetabular liner. As stated above, articulating components have been made from Co28Cr6Mo for a metal-on-metal bearing; high purity alumina or alumina matrix composite ceramics for a ceramic-on-ceramic bearing; and Co28Cr6Mo and alumina matrix composite (ISO 6474-2) for a metal-on-ceramic bearing. Modular acetabular shells have to date been made from Ti-6Al-4V or Co28Cr6Mo. The shell is considered part of the acetabular component. Acetabular components may have external coating and/or porous structure intended for uncemented, press-fit or biological fixation; or, for use with bone cement.1.3 This standard is a summary of available specifications, test methods, practices, and guides from published standards or the scientific literature. Their clinical relevance is unproven. Most of the methods do not have an established precision and bias; therefore, their repeatability and reproducibility has not been established. As the clinical relevance of these methods have not been established, consequently, most do not have performance requirements. This document does not require that all the listed methodologies are always necessary to evaluate these implant systems provided justification for not using each unused method is provided. This document does not intend to prevent the use of new methodologies as they are developed.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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