According to the latest report from the German Arthroplasty Registry, aseptic loosening is the primary cause of implant failure following primary hip arthroplasty. Osteolysis of the proximal femur due to the stress-shielding of the bone by the implant causes loss of fixation of the proximal femoral stem, while the distal stem remains fixed.

Removing a fixed stem is a challenging process. Current removal methods rely on manual tools such as chisels, burrs, osteotomes, drills and mills, which pose the risk of bone fracture and cortical perforation. Others such as ultrasound and laser, generate temperatures that could cause thermal injury to the surrounding tissues and bone. It is crucial to develop techniques that preserve the host bone, as its quality after implant removal affects the outcome of a revision surgery.

A gentler removal method based on the transcutaneous heating of the implant by induction is proposed. By reaching the glass transition temperature (T_G) of the periprosthetic cement, the cement is expected to soften, enabling the implant to be gently pulled out. The in-vivo environment comprises body fluids and elevated temperatures, which deteriorate the inherent mechanical properties of bone cement, including its T_G. We aimed to investigate the effect of fluid absorption on the T_G (ASTM E2716-09) and Vicat softening temperature (VST) (ISO 306) of Palacos R cement (Heraeus Medical GmbH) when dry and after storage in Ringer's solution for up to 8 weeks.

Samples stored in Ringer's solution exhibited lower T_G and VST than those stored in air. After 8 weeks, the T_G decreased from 95.2°C to 81.5°C in the Ringer's group, while the VST decreased from 104.4°C to 91.9°C. These findings will be useful in the ultimate goal of this project which is to design an induction-based system for implant removal.

Acknowledgements: Funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) – SFB/TRR-298-SIIRI – Project-ID 426335750

Introduction:

Extensive bone defects of the proximal femur e.g. due to aseptic loosening might require the implantation of megaprostheses. In the literature high loosening rates of such megaprostheses have been reported. However, different fixation methods have been developed to achieve adequate implant stability, which is reflected by differing design characteristics of the commonly used implants. Yet, a biomechanical comparison of these designs has not been reported.

The aim of our study was to analyse potential differences in the biomechanical behaviour of three megaprostheses with different designs by measuring the primary rotational stability in vitro.

Introduction

Concerning biomechanical research, human specimens are preferred to achieve conditions that are close to the clinical situation. On the other hand, synthetic femurs are used for biomechanical testing instead of fresh-frozen human femurs, to create standardized and comparable conditions. A new generation of synthetic femurs is currently available aiming to substitute the validated traditional one. Structural femoral properties of the new generation have already been validated, yet a biomechanical validation is missing.

The aim of our study was to analyse potential differences in the biomechanical behaviour of two different synthetic femoral designs by measuring the primary rotational stability of a cementless femoral hip stem.

Introduction

Infection following total joint arthroplasty is a major and devastating complication. After removal of the initial prosthesis, an antibiotic-impregnated cement spacer is inserted for approx. three months. Treatment is completed by a second stage revision arthroplasty.

Up to now, spacers are produced from conventional bone cements that contain abrasive radio-opaque substances like zirconium dioxide or barium sulphate. As long as spacer wear products (cement particles containing these hard substances) are not fully removed during the final revision surgery they may enter the articulating surfaces of the revision implant leading to third body wear.

In order to reduce the formation of reactive wear particles, a special cement (Copal(r) spacem) without abrasive zirconium dioxide or barium sulphate was developed.

To date, no comparative tribological data for cement spacers have been published. Hence, we carried out a study on the wear properties of Copal(r) spacem (with and without gentamicin) in comparison to conventional bone cements (Palacos(r) R and SmartSet(r) GHV).

Introduction

Osteolysis and aseptic loosening in total hip replacement (THR) is often associated with polyethylene (PE) wear. This caused interest in alternative bearing surfaces. Since the mid nineties, research focused on hard-hard bearings like metal-on-metal (MOM) or ceramic-on-ceramic (COC). However, concerns remain about biological reactions to metallic wear debris or failure of the ceramic components. A new approach to reduce wear with a minimized risk of failure may be the use of a metallic cup in combination with a ceramic head, the so called ceramic-on-metal bearing (COM). The aim of this study was to estimate the wear behaviour at an early stage of this COM bearing type in comparison to COC bearings using a hip simulator.

Knee wear simulator studies are performed to evaluate wear behavior of implants.

Simulation of the human gait cycle is often carried out continuously, without considering resting periods as they are part of patient’s daily live. In addition to dynamic activities like walking, daily activities also consist of static periods like standing, sitting or lying. During the day dynamic activities alternate continuously with static periods and most of the day is spent in passive periods, where no joint motion occurs. Such resting periods have not yet been considered in prosthetic knee wear tests. Implementing resting periods may cause an increase in friction and thus increased wear of the implant. The aim of the current study was to determine if the implementation of resting periods would increase polyethylene (PE) wear in total knee replacement (TKR).

Two wear studies were conducted using a force controlled AMTI knee simulator on a conventional bicondylar TKR. For the first study, simulation was carried out continuously according to ISO 14243-1. For the second test, four active gait cycles according to ISO 14243-1 were followed by one resting period cycle. In both tests 5x10E6 active load cycles at a frequency of 1 Hz (resulting in additional 1.25x10E6 pause cycles for the second test) were applied. Wear was measured gravimetrically and wear scars were documented photographically.

The mean wear rates measured 2.85 ± 0.27 mg/10E6 cycles for the ISO test without considering resting periods and 2.27 ± 0.23 mg/10E6 cycles for the test with resting periods implemented. There was no significant difference (p=0.22) in wear rate between both tests.

The inserts showed similar wear scars in both tests and no relevant differences in dimension and localization on the surface. Therefore the wear behavior after the two tests was similar.

Since wear is one of the most limiting factors for implant longevity, proper preclinical wear studies are essential. Based on the results of this experimental wear study, a continuous simulation without additional resting periods seems to be valid in wear simulation of TKR.

Introduction: During hip stem revisions osteotomies allow to remove well-fixed components. Once removal has been done, cerclage wires should secure the osteotomy and support primary stability of the new stem. Stability is important for a bony ingrowth and therefore the longevity of a cementless revision stem.

Tension wires seem to dominate revision surgery and studies only refer to the advantages of cable wires in general. This in-vitro study analyzed the infiuence of both, tension and cable wires on primary stability of cementless revision stems. We aimed to examine the effectivity of wiring a femoral osteotomy, differences achieved with each method, and whether one wire has advantages regarding the fixation concepts of revision stems (meta- and diaphyseal).

Methods: We studied a Ti-tension- and a CoCrWNi-cable-wire. The Helios-stem stood for the meta- and the Wagner-SL-stem for the diaphyseal fixation concept. Each stem was implanted into 3 synthetic femurs and a standardized extended proximal femoral osteotomy was performed. Spatial movements of bones and stems at several sites were explored under axial torques using a high-resolution measuring device. Movement graphs subjected to the sites defined relative movements RM = ΔαZ/TZ [mdeg/Nm]. The osteotomies were locked consecutively with both wires and all compounds were measured again. Wiring was done by a proximal figure 8 and a diaphyseal circular loop.

Results: Compared to the unlocked osteotomy the tension as well as the cable wires caused a changed RM for the stems (p=0.03). Both wires affect an increased stability within the proximal main fixation area of the Helios. Even for the Wagner-SL, usually fixating diaphyseally, a proximal fixation was reached with both wires. A significantly better stabilization could be observed for the Helios using cable wires (p=0.04). The overall RM reached with tension and cable wires was 16.6 and 11.1 mdeg/Nm. The Wagner-SL^® showed no difference in stability between tension and cable wire treatment (p=0.29).

Discussion: Both, the tension and the cable wires support the revision stems in bridging the artificial defect of an extended proximal femoral osteotomy. Especially for the proximal fixating stem, RMs could largely be reduced, while cable wires seem to be advantageous. Preventing a circular constriction leading to an osseous malnutrition, the use of cable wires, however, should be impeded with regard to diaphyseal fixating stems and proximal osteotomies. Comparable results with both wires were reached and none of the wires showed any advantage in this situation. In conclusion, the wires should be chosen depending on the fixation concept of the revision stem.

Introduction: Postoperative periprosthetic fractures are difficult to investigate clinically in scientifically and statistically valid study samples because they are uncommon. However, the combination of advanced age and poor bone quality has been associated with these fractures in conjunction with cementless hip stems. So far, these speculations have neither been supported by clinical evidence nor been investigated experimentally. The purpose of the present study was to analyze in-vitro if the treatment with cementless hip stems increases the risk of suffering a periprosthetic fracture for older patients compared to younger patients. Regarding this manner, we aimed to clarify parameters which possibly can be used preoperatively to assess age related fracture risk and whether the femoral bone quality really plays a role in fracture development.

Methods: An established biomechanical setup was used to provide an investigation on 16 femoral specimens of different age. Prior, the BMDs were measured in 5 ROIs and a cementless hip stem was implanted into each femur. The load bearing of “normal walking” was applied quasistatically under standardized conditions until the fracture occurred. The specimens were arranged by age in ascending order to divide them in the middle. A group of under septuagenarians (< 70y) (mean: 62y) and a group representing an elderly population (≥77y) (mean: 79y) resulted. Important donor data such as body height and bodyweight were considered in the statistical analysis.

Results: The elderly specimens fractured at significantly lower forces (< 70y: Fmax=5,308N; ≥77y: Fmax=2,519N; p< 0.01). Pearson’s test revealed a correlation for Fmax [N] and age (p < 0.01; r = −0.64); and for Fmax [%BW] and age (p < 0.01; r = −0.69). Fracture loads were found to correlate strongly with age (p=0.01), all used ROIs (e.g. for Ward’s triangle: p< 0.01) and BMI (p=0.04). Decreasing CCD angles were found with increasing age (p < 0.01).

Discussion: In patients with advanced age treated with cementless hip stems the risk of suffering a periprosthetic fracture is significantly higher. The identification of specific fracture development variables in geriatric populations can be extended to a preoperative check list to aid clinicians in practicing effective risk assessment. Criteria such as BMD, BMI and CCD angle should be included: A fracture risk remains in patients around 80 years of age or older, with a Ward’s triangle BMD below a value of 0.500g/cm2, or a BMI > 33kg/m2. Depending on patient activity, one single factor should not be viewed as an exclusion criterion for a cementless hip stem, whereas the cumulation of them should alert the surgeon.

Resurfacing hip implants differ in macro- and microstructure. Manufacturing related parameters like clearance or carbon content influence the wear behaviour of these metal-on-metal bearings. The aim of this study was to analyse the main macro- and micro-structural differences of commercially available resurfacing hip implants.

Ten different commercially available resurfacing hip implant designs were included in this investigation:

- BHR^® (Smith& Nephew/MMT)

The heads and cups were measured in a coordinate measuring machine and radial clearance as well as sphericity deviation were calculated. Surface roughness measurements were carried out. The microstructures of the heads and cups were inspected using SEM and element analysis was performed using EDX to identify carbides and the alloy composition.

The mean radial clearance was found to be 85.53 μm. The range was from 49.47 μm (DePuy, ASR^®) to 120.93 μm (Biomet, ReCap^®). All implants showed a sphericity deviation of less than 10 μm. The highest sphericity deviation was found to be 7.3 μm (Corin Cormet^® head), while the lowest was 0.8 μm (Smith& Nephew BHR^® head). On average, the heads tended to have a higher sphericity deviation (4.1 μm, SD: 2.3 μm) compared to the cups (2.7 μm, SD: 1.4 μm). SEM revealed that most manufacturers use a high carbon alloy casting manufacturing process combined with heat treatment after casting (Corin Cormet^® and Wright Conserve^®: head and cup; DePuy ASR^®: cup; Eska BS^®: head).

Commercially available resurfacing hip implants differ in design and manufacturing parameters, including macro- and microstructure, which are critical in achieving low wear and ion release. This study was designed to aid in the understanding of clinical observations. Also, specific information is now available for surgeons choosing an implant designs.

Resurfacing hip implants differ in macro-and microstructure. Manufacturing related parameters like clearance or carbon content influence the wear behaviour of these metal-on-metal bearings. The aim of this study was to analyse the main macro- and micro-structural differences of commercially available resurfacing hip implants. Ten different commercially available resurfacing hip implant designs were included in this investigation:

BHR^® (Smith& Nephew/MMT) Durom® (Zimmer)

The heads and cups were measured in a coordinate measuring machine and radial clearance as well as sphericity deviation were calculated. Surface roughness measurements were carried out. The microstructures of the heads and cups were inspected using SEM and element analysis was performed using EDX to identify carbides and the alloy composition. The mean radial clearance was found to be 85.53μm. The range was from 49.47μm (DePuy, ASR®) to 120.93μm (Biomet, ReCap®). All implants showed a sphericity deviation of less than 10μm. The highest sphericity deviation was found to be 7.3μm (Corin Cormet® head), while the lowest was 0.8μm (Smith& Nephew BHR® head). On average, the heads tended to have a higher sphericity deviation (4.1μm, SD: 2.3μm) compared to the cups (2.7μm, SD: 1.4μm). SEM revealed that most manufacturers use a high carbon alloy casting manufacturing process combined with heat treatment after casting (Corin Cormet® and Wright Conserve®: head and cup; DePuy ASR®: cup; Eska BS®: head). Commercially available resurfacing hip implants differ in design and manufacturing parameters, including macro- and microstructure, which are critical in achieving low wear and ion release. This study was designed to aid in the understanding of clinical observations. Also, specific information is now available for surgeons choosing an implant designs.

For wear testing of knee implants, ISO 14243 is the most used testing protocol. In force control, this standard requires linear motion restraints for simulation of ligaments. The aim of this study was to investigate if a nonlinear, physiological motion restraint would influence the wear behaviour of the implants.

A wear study was performed on a highly conforming knee implant design. Three implants were tested forced controlled according to ISO 14243-1 on an AMTI knee simulator. Linear motions restrain of 30 N/mm for AP-translation and 0.6 Nm/° for IE-rotation were applied as required per ISO 14243-1. A second wear test was performed on the same implant design. Based on the data given by Kanamori et al. and Fukubayashi et al., a physiological, nonlinear ligament constraint model (sectioned ACL) was adopted and implemented in the simulation. The implants were pre-soaked and a soak controls was used. Wear was measured gravimetrically.

A mean gravimetric wear rate of 2.85 mg/10E6 cycles was found for the implants which were tested using a linear motion restraint as required per ISO 14243-1. Simulating a physiological, nonlinear motion restraint resulted in a 60% increase in gravimetric wear (mean gravimetric wear rate: 4.75 mg/10E6 cycles). As expected, the kinematics of the implants differed between wear tests. The mean AP-translation increased from 2.89 mm (linear motion restraint) to 4.82 mm (physiological motion restraint). A similar behaviour was observed for the IE-rotation. The IE-rotation increased from 4.09° (linear motion restraint) to 5.94° (physiological motion restraint).

The reaction of the ligaments is not linear in the human knee joint. This study showed that wear and kinematics change when simulating physiological ligament reactions. Wear increased by 60%, an effect which can likely be credited to fundamental differences in kinematics. The ACL is commonly sacrificed during surgery. Thus, more attention should be paid to ligament simulation when performing wear tests on knee implants.

The introduction of mobile bearings for unicompartimental knee implants resulted in heightened interest in this implant design in the field of orthopaedics. This study aims to determine the effect of the mobile and fixed design concepts on the wear progression in unicompartmental knee implants using a knee simulator.

An unicompartmental knee implant design, which is available in a fixed and mobile version, was tested using a knee simulator. For the wear test, the medial and lateral compartments were implemented in the simulator. To account for the physiologically higher medial load compared to the lateral compartment, a medially-biased load distribution was implemented. The wear test was performed force controlled according to ISO 14243. Wear was measured gravimetrically separately for the medial and lateral compartments. To evaluate implant kinematics, AP-translation and IE-rotation were measured during the simulation.

Gravimetric wear was higher medially than laterally for both designs. The mean wear rate of the medial mobile compartment was found to be 10.70 mg/10E6 cycles, whereas a mean wear rate of 6.05 mg/10E6cycles was found for the medial compartment of the fixed design. Lateral wear rates, which were about 50% lower than medial wear rates, were found to be 5.38 mg/10E6 cycles in the mobile design and 3.23 mg/10E6 cycles in the lateral design. Wear of the mobile design was higher compared to the fixed design, both medially and laterally. Surprisingly the kinematics of both designs were very similar. A low AP-translation of 2.7 mm in the mobile and 2.4 mm in the fixed designs was documented. High IE-rotations of 6.5° and 6.7° for the mobile and the fixed design, respectively, were observed.

In bicondylar bearing knee designs, reduced wear has been reported for mobile polyethylene inlays. This study showed that the wear behaviour of unicompartmental knee implants differs from bicondylar implants and that the introduction of the mobile concept may lead to increased wear.

In hip joint simulator studies, wear measurement is usually performed gravimetrically. This procedure is reliable for metal-on-polyethylene or ceramic-on-polyethylene bearings, in which relatively high amounts of abrasive wear particles are produced. With modern hard-on-hard bearings, volumetric wear decreases significantly up to 100 to 200-fold. The gravimetric method reaches its detection limit with metal-on-metal bearings and even more so with ceramic-on-ceramic bearings. This study establishes a new method of determining wear in hard-on-hard bearings by measuring the amount of worn particles/ions in the serum of hip simulators.

A wear study on three resurfacing hip implants (BHR^®, Smith& Nephew) was conducted using a hip joint simulator. Prior to the wear study, tests were performed to validate the detection power for high resolution-inductively coupled plasma-mass spectrometry (HR-ICP-MS). More importantly the system’s accuracy was compared to the gravimetric method, which is described in ISO 14243-2. The simulator was altered to run completely metal ion free. The ion concentration in the serum was measured every 100 000 cycles up to 1 500 000 cycles and subsequently in intervals of 500 000 cycles using HR-ICP-MS. The implants were neither removed from the simulator nor excessively cleaned during the course of the simulation. Serum was refreshed every 500 000 cycles. The serum samples were digested with purified nitric acid and hydrogen peroxide using a high pressure microwave autoclave in order to measure wear particles as well as dissolved ions. All steps were carried out under clean room conditions. Wear was calculated using the ion concentration and measured serum volume. Wear rates and transition from running-in to steady-state wear phases were calculated.

A detection power better than 0.028 μg/l for Co (cobalt), 0.017 μg/l for Cr (chromium) and 0.040 μg/l for Mo (molybdenum) was found for HR-ICP-MS. The validation of HR-ICP-MS showed good agreement between gravimetric data and measured ion concentrations. The tested implants showed similar wear behaviour. Implant wear resulted in high ion concentrations during the first 380 000 to 920 000 cycles. During this period, a mean wear rate of 6.96 mm3/10E6 cycles was determined. Subsequently, the wear rate significantly decreased to a mean wear rate of 0.37 mm3/10E6 cycles. Thus, a mean ratio between running-in and steady-state wear of 18.8 was found. The mean overall wear volume at the end of the simulation was 4.42 mm3.

This study showed that measuring the ion concentrations in the serum of hip simulators can be used to determine wear in metal-on-metal bearings. The main advantages of this new method are the ability to detect ultra-low wear rates and to precisely specify the duration of different wear phases. Because the implants do not have to be removed from the simulator and aggressive cleaning processes may be skipped, fluctuations in wear detection are extremely low. This in turn leads to a shorter duration of the simulation. Wear rates of the tested implants are low compared to polyethylene. Transferring the results to patient activity, wear would be the same during the first four to six months after implantation as in the next ten years. Minimizing the duration of running-in would be most effective in further reducing wear of metal-on-metal bearings.