Hip Cup Research Articles

Feasibility of a Shape-Memory-Alloy-Actuator System for Modular Acetabular Cups.

Hip implants have a modular structure which enables patient-specific adaptation but also revision of worn or damaged friction partners without compromising the implant-bone connection. To reduce complications during the extraction of ceramic inlays, this work presents a new approach of a shape-memory-alloy-actuator which enables the loosening of ceramic inlays from acetabular hip cups without ceramic chipping or damaging the metal cup. This technical in vitro study exam-ines two principles of heating currents and hot water for thermal activation of the shape-memory-alloy-actuator to generate a force between the metal cup and the ceramic inlay. Mechanical tests concerning push-in and push-out forces, deformation of the acetabular cup according to international test standards, and force generated by the actuator were generated to prove the feasibility of this new approach to ceramic inlay revision. The required disassembly force for a modular acetabular device achieved an average value of 602 N after static and 713 N after cyclic loading. The actuator can provide a push-out force up to 1951 N. In addition, it is shown that the necessary modifications to the implant modules for the implementation of the shape-memory-actuator-system do not result in any change in the mechanical properties compared to conventional systems.

Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature

Purpose The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. Methods We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology. Conclusion The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.

Evaluating the Feasibility and Reproducibility of a Novel Insertion Method for Modular Acetabular Ceramic Liners.

Modern hip implants have a modular design. In case of wear or other damage it allows surgeons to change the tribological partners, i.e., the acetabular liner and femoral ball. In both revision and primary surgery, the secure joining of the implant components is important for the success of the operation. The two components, namely the ceramic liner and hip cup, are connected via a conical press connection and should be concentrically aligned to avoid chipping. Malseated liners can reduce the life span in situ. The amount of the joining force, which is usually applied via a hammer, depends on the surgeon. In this study, an alternative joining method for acetabular ceramic liners in hip cups was investigated, which intends to make the process more reproducible and thus safer. For this purpose, a handpiece was used to apply a defined force impulse of 4 kN. For the concentric alignment of a ceramic liner in the hip cup, an adapter was developed based on findings via a qualitative finite element (FE) analysis. Insertion and pushout tests of the acetabular cup-liner connection were performed in the laboratory with the new instrument (handpiece with the connected adapter) to evaluate the functionality of the instrument and the reproducibility of the new insertion method. For comparison, liners and acetabular cups were joined using a testing machine according to the standard. The presented results demonstrate the technical proof-of-concept of the new joining method under laboratory conditions. They meet the acceptance criteria of established manufacturers, which proves the equivalency to proven methods for joining modular implant components. To verify the improvement of the new joining method compared to the conventionally used joining method, an application-oriented study with different surgeons and the new joining instrument under clinical conditions is necessary.

Recent Advances in the Production of Pharmaceuticals Using Selective Laser Sintering.

Selective laser sintering (SLS) is an additive manufacturing process that has shown promise in the production of medical devices, including hip cups, knee trays, dental crowns, and hearing aids. SLS-based 3D-printed dosage forms have the potential to revolutionise the production of personalised drugs. The ability to manipulate the porosity of printed materials is a particularly exciting aspect of SLS. Porous tablet formulations produced by SLS can disintegrate orally within seconds, which is challenging to achieve with traditional methods. SLS also enables the creation of amorphous solid dispersions in a single step, rather than the multi-step process required with conventional methods. This review provides an overview of 3D printing, describes the operating mechanism and necessary materials for SLS, and highlights recent advances in SLS for biomedical and pharmaceutical applications. Furthermore, an in-depth comparison and contrast of various 3D printing technologies for their effectiveness in tissue engineering applications is also presented in this review.

Simulation-Based Process Design for Asymmetric Single-Point Incremental Forming of Individual Titanium Alloy Hip Cup Prosthesis.

Advanced manufacturing techniques aimed at implants with high dependability, flexibility, and low manufacturing costs are crucial in meeting the growing demand for high-quality products such as biomedical implants. Incremental sheet forming is a promising flexible manufacturing approach for rapidly prototyping sheet metal components using low-cost tools. Titanium and its alloys are used to shape most biomedical implants because of their superior mechanical qualities, biocompatibility, low weight, and great structural strength. The poor formability of titanium sheets at room temperature, however, limits their widespread use. The goal of this research is to show that the gradual sheet formation of a titanium biomedical implant is possible. The possibility of creative and cost-effective concepts for the manufacture of such complicated shapes with significant wall angles is explored. A numerical simulation based on finite element modeling and a design process tailored for metal forming are used to complete the development. The mean of uniaxial tensile tests with a constant strain rate was used to study the flow behavior of the studied material. To forecast cracks, the obtained flow behavior was modeled using the behavior and failure models.

Automatic generation of 3d spiral tool path for incremental sheet metal forming of mechanical parts with complex geometry

Incremental sheet metal forming is a flexible manufacturing technology that allows to form of various components on the same milling machine, without expensive tools. A hemispherical tool moves along a CNC-controlled tool path and deforms the sheet into the desired shape. The tool path has a significant role in the geometric accuracy of the final part. There has been very little research on the problem of the forming of sophisticated parts with asymmetric wall angles. This paper presents a new approach to generating optimized tool paths for single-point incremental sheet forming (SPIF). At first, a strategy is proposed for the automatic generation of a 3D tool path during forming in a single-step operation. Then, a systematic technique of creating intermediate shapes is investigated by defining tool paths interpolated from the final part shape. The proposed methodology is applied to form a hip cup prosthesis. This part has a complex asymmetric geometry with important angles, a multi-step approach is used. The proposed methodology to define the different tool paths was implemented in Matlab. A numerical simulation of the incremental forming process is performed to predict the final geometry of the aluminum sheet. A comparison of desired and predicted geometries shows the reliability of the proposed method.

Influence of acetabular cup thickness on seating and primary stability intotal hip arthroplasty.

Insufficient primary stability of acetabular hip cups is a complication resulting in early cup loosening. Available cup designs vary in terms of wall thickness, potentially affecting implant fixation. This study investigated the influence of different wall thicknesses on the implantation process and the resulting primary stability using excised human acetabula. Implantations were performed using a powered impaction device providing consistent energy with each stroke. Two different wall thicknesses were compared in terms of seating progress, polar gap remaining after implantation, bone-to-implant contact area, cup deflection, and lever out moment. Thin-walled cups showed higher lever out resistance (p < 0.001) and smaller polar gaps (p < 0.001) with larger bone contact towardthe dome of the cup (p < 0.001) compared to thick-walled cups. Small seating steps at the end of the impaction process were observed if a high number of strokes were needed to seat the cup (p = 0.045). A high number of strokes led to a strain release of the cup during the final strokes (p = 0.003). This strain release is indicative for over-impaction of the cup associated with bone damage and reduced primary stability. Adequate cup seating can be achieved with thin-walled cups with lower energy input in comparison to thicker ones. Thin-walled cups showed improved primary stability and enable implantation with lower energy input, reducing the risk of over-impaction and bone damage. Additional strokes should be avoided as soon as no further seating progress has been observed.

Jumbo cup in hip joint renovation may cause the center of rotation to increase.

BACKGROUNDUtilizing the large jumbo cup in revision total hip arthroplasty is an effective approach to cure many lacunar and segmental peripheral bone defects. However, with the use of the jumbo cup, the center of the hip joint may become elevated relative to the primary acetabulum, and the diameter of the large cup is greater.AIMTo study the height and the significance of the elevation of the hip joint center.METHODSEighty-eight patients matched the criteria for this condition and were included in the study. The center height of the hip joint was measured relative to the opposite normal hip joint. The diameter of the jumbo cup was measured and checked according to operation notes, and the diameter of the jumbo cup was measured with a prosthesis label. Then, the horizontal and vertical centers of rotation were measured on the surgical side and opposite side. The average center height of the hip joint on the renovated side and the opposite side and the position of the hip cup relative to the teardrop were compared using a paired t-test.RESULTSRadiometric analysis showed that the average hip joint center was elevated by 7.6 mm. The rotational center height delta of the renovated hip was 7.6 ± 5.6 mm, and there was an obvious difference between the two groups (P = 0.00). The difference in horizontal distance was 0.5 ± 5.1 mm (-11.5 -14.0 mm), and there was no obvious difference between the two groups (P = 0.38). According to the foreign standard, the rotational center height delta of the renovated hip was 7.5 ± 6.2 mm, and there was a significant difference between the two groups (P = 0.00). There was no obvious difference between the domestic and foreign standards (P > 0.05) between the two groups.CONCLUSIONThe application of the jumbo cup elevates the rotational center of the hip joint, but it is feasible and effective to use the jumbo cup.

Results of single-stage acetabulum reconstruction and total hip arthroplasty in the management of pelvic discontinuity caused by ununited acetabulum fracture

Introduction: Non-union of acetabulum fracture is a common occurrence in developing countries. Pelvic discontinuity due to ununited fracture acetabulum poses a serious challenge in the management of the patient. Results of ORIF of these fractures are not promising due to various reasons. We aim to present results on single-stage acetabulum reconstruction and total hip arthroplasty, the literature on which is lacking. Materials and Methods: We prospectively studied the outcome of single-stage acetabulum reconstruction and total hip arthroplasty in patients with pelvic discontinuity caused by ununited fracture acetabulum of more than 3 months duration. From March 2015 to December 2018, 11patients (7 males, 4 females, average age 42 years) were treated in our hospital. All cases underwent open reduction internal fixation with posterior column plate, impaction bone grafting, uncemented porous coated hemispherical acetabulum cup hip arthroplasty. Results: Union of the columns was achieved in all the cases with 7 patients (63.6%) showed union at 12 months and rest 4 patients (36.4%) took 18 months to unite. At final follow up, mean Harris hip score improved from 54.2 points (range 24-63) to 91.4 points (range 79-95). One superficial surgical site infection and one heterotopic ossification was noted in our study which had no sequel on clinical outcome at their last follow up. Conclusion: Single stage acetabulum reconstruction by posterior column plating with impaction bone grafting and uncemented porous coated hemispherical acetabulum cup hip arthroplasty is a genuine option in management of pelvic discontinuity caused by ununited fracture of acetabulum. Keywords: Neglected fracture acetabulum, Ununited fracture acetabulum, Pelvic discontinuity, Acetabulum reconstruction, Single stage acetabulum reconstruction.

Personalized Cup Positioning Guides Improved Cup Positioning and Hip Ranges of Motion in Robotic Assisted Total Hip Arthroplasty.

ObjectivePrecise hip cup positioning is essential for the prevention of component impingement and dislocation in robotic assisted total hip arthroplasty (THA). Currently, the robotic system uses a mechanical alignment guide (MAG) for cup placement, which is one-size-fits-all, and the optimal cup positioning is controversial. Robotic assisted THA has not used any personalized cup positioning guides. The goal of this study was to identify an optimal guide for cup placement in robotic assisted THA to improve prognosis and life quality after THA.Materials and MethodsPelvis and femoral CT data of 47 participants were retrospectively collected for preoperative planning of robotic THA. The universal MAG guide and three personalized guides, including acetabular rim labrum guide (ARLG), transverse acetabular ligament guide (TALG), and ischiatic-pubis line guide (IPLG), were used to pose cups in the acetabulum of each participant. The position of cups was evaluated by inclination and anteversion; the function of hip joints was evaluated by hip ranges of motion, including abduction, adduction, extension, flexion, internal rotation, and external rotation.ResultsIn terms of cup positioning, ARLG provided a bigger cup inclination (p < 0.0001), while IPLG and TALG provided smaller cup inclination (p < 0.001) than MAG; the three personalized guides provided larger cup anteversion (p < 0.0001) than MAG. In terms of HROMs, compared with the use of MAG, the use of three personalized guides significantly decreased abduction (p < 0.0001), extension (p < 0.0001), and external rotation (p < 0.0001), but increased significantly flexion (p < 0.0001) and internal rotation (p < 0.0001); the use of ARLG significantly reduced adduction (p < 0.0001), but the use of IPLG and TALG increased adduction (p < 0.0001).ConclusionCompared with MAG, personalized guides provided greater flexion and internal rotation, which may reduce the risk of posterior dislocation. Among the three personalized guides, IPLG is the most reliable one for the preoperative planning of robotic assisted THA.

Quantitative Measurements of Backside Wear in Acetabular Hip Joint Replacement: Conventional Polyethylene Versus Cross-Linked Polyethylene.

As shown in previous studies, the modification of conventional polyethylene (CPE) to cross-linked polyethylene (XLPE) and the contribution of antioxidants result in a reduction in total wear. The aim of this study was to evaluate XLPE inserts with vitamin E and CPE regarding their resistance to the backside wear mechanism. A cementless hip cup system (Plasmafit® Plus 7, Aesculap) was dynamically loaded using CPE and XLPE inserts. The backside wear was isolated, generated and collected using the two-chamber principle. The chambers were filled with ultrapure water. After 2 × 106 cycles, the fluids were examined for wear particles according to a particle analysis. Using XLPE inserts, the backside wear was significantly reduced by 35%. While XLPE backside wear particles are significantly larger than CPE particles, they do not differ in their morphology. This study confirms the greater resistance to backside wear of XLPE compared to CPE. It can be assumed that the improved fatigue resistance of the vitamin E-stabilized XLPE inserts demonstrates XLPE’s effectiveness against micro-motion and the resulting changing tensions in interface areas like surface breakdown, pitting and the release of very small particles.

The Impingement-free, Prosthesis-specific, and Anatomy-adjusted Combined Target Zone for Component Positioning in THA Depends on Design and Implantation Parameters of both Components.

BackgroundLewinnek’s recommendation for orienting the cup in THA is criticized because it involves a static assessment of the safe zone and because it does not consider stem geometry. A revised concept of the safe zone should consider those factors, but to our knowledge, this has not been assessed.Questions/purposes(1) To determine the shape, size, and location of target zones for combined cup and stem orientation for a straight stem/hemispheric cup THA to maximize the impingement-free ROM and (2) To determine whether and how these implant positions change as stem anteversion, neck-shaft angle, prosthetic head size and target range of movements are varied.MethodsA three-dimensional computer-assisted design model, in which design geometry was expressed in terms of parameters, of a straight stem/hemispheric cup hip prosthesis was designed, its design parameters modified systematically, and each prosthesis model was implanted virtually at predefined component orientations. Functional component orientation referencing to body planes was used: cups were abducted from 20° to 70°, and anteverted from -10° to 40°. Stems were rotated from -10° to 40° anteversion, neck-shaft angles varied from 115° to 143°, and head sizes varied from 28 to 40 mm. Hip movements up to the point of prosthetic impingement were tested, including simple flexion/extension, internal/external rotation, ab/adduction, combinations of these, and activities of daily living that were known to trigger dislocation. For each combination of parameters, the impingement-free combined target zone was determined. Maximizing the size of the combined target zone was the optimization criterion.ResultsThe combined target zones for impingement-free cup orientation had polygonal boundaries. Their size and position in the diagram changed with stem anteversion, neck-shaft angle, head size, and target ROM. The largest target zones were at neck-shaft angles from 125° to 127°, at stem anteversions from 10° to 20°, and at radiographic cup anteversions between 17° and 25°. Cup anteversion and stem anteversion were inverse-linearly correlated supporting the combined-anteversion concept. The range of impingement-free cup inclinations depended on head size, stem anteversion, and neck-shaft angle. For a 127°-neck-shaft angle, the lowest cup inclinations that fell within the target zone were 42° for the 28-mm and 35° for the 40-mm head. Cup anteversion and combined version depended on neck-shaft angle. For head size 32-mm cup, anteversion was 6° for a 115° neck-shaft angle and 25° for a 135°-neck-shaft angle, and combined version was 15° and 34° respectively.ConclusionsThe shape, size, and location of the combined target zones were dependent on design and implantation parameters of both components. Changing the prosthesis design or changing implantation parameters also changed the combined target zone. A maximized combined target zone was found. It is mandatory to consider both components to determine the accurate impingement-free prosthetic ROM in THA.Clinical RelevanceThis study accurately defines the hypothetical impingement-free, design-specific component orientation in THA. Transforming it into clinical precision may be the case for navigation and/or robotics, but this is speculative, and as of now, unproven.

Low-dose CT-based implant motion analysis is a precise tool for early migration measurements of hip cups: a clinical study of 24 patients

Background and purpose — Early implant migration is known to be a predictive factor of clinical loosening in total hip arthroplasty (THA). Radiostereometric analysis (RSA) is the gold standard used to measure early migration in patients. However, RSA requires costly, specialized imaging equipment and the image process is complex. We determined the precision of an alternative, commercially available, CT method in 3 ongoing clinical THA studies, comprising 3 different cups.Materials and methods — 24 CT double examinations of 24 hip cups were selected consecutively from 3 ongoing prospective studies: 2 primary THA (1 cemented and 1 uncemented) and 1 THA (cemented) revision study. Precision of the CT-based implant motion analysis (CTMA) system was calculated separately for each study, using both the surface anatomy of the pelvis and metal beads placed in the pelvis.Results — For the CTMA analysis using the surface anatomy of the pelvis, the precision ranged between 0.07 and 0.31 mm in translation and 0.20° and 0.39° for rotation, respectively. For the CTMA analysis using beads the precision ranged between 0.08 and 0.20 mm in translation and between 0.20° and 0.43° for rotations. The radiation dose ranged between 0.2 and 2.3 mSv.Interpretation — CTMA achieved a clinically relevant and consistent precision between the 3 different hip cups studied. The use of different hip cup types, different CT scanners, or registration method (beads or surface anatomy) had no discernible effect on precision. Therefore, CTMA without the use of bone markers could potentially be an alternative to RSA to measure early migration.

Effect of different motor tasks on hip cup primary stability and on the strains in the periacetabular bone: An in vitro study

BackgroundExcessive prosthesis/bone motions and the bone strains around the acetabulum may prevent osteointegration and lead to cup loosening. These two factors depend on post-operative joint loading. We investigated how Walking (which is often simulated) and Standing-Up from seated (possibly more critical) influence the cup primary stability and periacetabular strains. MethodsTwelve composite hemipelvises were used in two test campaigns. Simplified loading conditions were adopted to simulate Walking and Standing-Up. For each motor task, a single-direction force was applied in load packages of increasing amplitude. Stable and unstable uncemented cups were implanted. Digital image correlation was used to measure implant/bone motions (three-dimensional translations and rotations, both permanent and inducible), and the strain distribution around the acetabulum. FindingsWhen stable implants were tested, higher permanent cranial translations were found during Walking (however the resultant migrations were comparable with Standing-Up); higher rotations were found for Standing-Up. When unstable implants were tested, motions were 1–2 order of magnitude higher. Strains increased significantly from stable to unstable implants. The peak strains were in the superior aspect of the acetabulum during Walking and in the superior-posterior aspect of the acetabulum and at the bottom of the posterior column during Standing-Up. InterpretationDifferent cup migration trends were caused by simulated Walking and Standing-Up, both similar to those observed clinically. The cup mobilization pattern depended on the different simulated motor tasks. Pre-clinical testing of new uncemented cups could include simulation of both motor tasks. Our study could also translate to indication of what tasks should be avoided.

Backside wear, particle migration and effectiveness of screw hole plugs in acetabular hip joint replacement with cross-linked polyethylene

In total hip arthroplasty, osteolysis of the acetabulum often occurs at the backside of cups in the area of screw holes, indicating a clinically relevant amount of polyethylene (PE) wear particles in this area. In order to avoid a possible migration of wear particles to the acetabulum-bone, screw hole plugs are provided for some implant systems. The aims of this study were to quantitatively determine backside wear and to investigate the migration behaviour of articulation-related wear particles in a cup system with open and closed screw holes by plugs.Titanium cup systems with backside holes for screw fixations were sinusoidally loaded with 2.7 kN. The articulation area was separated from the backside area of the cup. A defined amount of articulation-generated particles was added to the fluid of the articulation chamber. The fluids in the two chambers were separately filtered after 2 × 106 cycles for a particle analysis.Backside wear with noticeably small (65.6 ± 4.2 nm) and round PE particles was identified. With both open and closed screw holes, a migration of the articulating wear particles from the articulation area behind the cup could be observed.Backside wear was estimated to be below 1% of the articulated wear. Screw hole plugs did not effectively prevent the migration of PE wear particles behind the investigated cups. Statement of SignificanceBackside wear occurs in a proven cup-system. Furthermore, it was quantitatively observed that articulation-generated wear products could migrate from the articulating area along the cup/liner-interface through the screw holes behind the cup. An almost unimpeded particle migration to the acetabulum-bone, in conjunction with very small backside wear particles, could produce a clinically relevant amount of PE with respect to pelvic lysis. These findings highlight the importance of management to avoid particle migration in artificial hip cups. Therefore, primarily the use of screw hole plugs, as far as available for the respective cup-system, is recommended. The aim of avoiding particle migration by plugs, but also by using a sophisticated anchoring mechanism between cup and PE liner should continue in future.

Antibiotic-laden cement wrap: A simple but effective way of treating patients with megaprosthesis infection.

This was a retrospective study of patients with megaprosthesis infection. From January 2014 to June 2016, there were five patients with tumour megaprosthesis infection who had undergone the ALCW procedure. Ages ranged from 17 to 59 years of age. Male to female ratio was 4:1. The patients studied had humeral (1), proximal femoral (1), distal femoral (1) and proximal tibial (2) prostheses. All patients had follow-ups more than 1 year (21-52 months) after treatment. All patients recovered from their implant infection and the implants were retained in all patients. There was no sign of infection in the most recent follow-up. One patient died of osteosarcoma recurrence. One patient had a large block of cement causing plastic insert dislodgement in the shoulder joint 1 year after surgery. Another patient with a dislocated hip cup had revision carried out in the final debridement. The most recent Musculoskeletal Tumor society (MSTS) scores ranged from 21 to 30. All patients were satisfied with their treatment. In this preliminary report of a small number of patients, ALCW has achieved 100% infection control. ALCW may be an easy and effective alternative for managing the megasprosthesis infection. The complications associated can be avoidable. The functional outcome is excellent.

Backside wear in acetabular hip joint replacement

IntroductionBesides head-insert articulation in hip joint replacements, micro-motions between the backside of assembled polyethylene acetabular liners and the metal cup may cause additional wear. Pelvic osteolysis frequently occurs in the region of screw holes, and cup loosening hints to clinically relevant amounts of polyethylene backside wear. It has yet to be confirmed whether backside wear particles differ in size and morphology compared to articulating wear. Previous methods have been limited to subjective assessment of backside surface damages without consideration of wear debris. The aim of this study was to develop and validate a method for quantitative in vitro measurements of polyethylene backside wear in artificial hip cups and to characterize these wear particles for the first time. MethodsTitanium cup-systems (Plasmafit®Plus7, Aesculap, UHMWPE liner) were sinusoidally loaded (2.5 kN) and a torque of 5 Nm was simultaneously applied. The front and rear side of the cup were separated to isolate backside wear. After 2 × 106 cycles the surrounding fluid was filtered and a particle analysis was performed. ResultsBackside wear had a particles size of 64.1 ± 1.9 nm and was verified as round and oval particles with partly rough outlines. An estimated total number of particles of 1.26 × 109 ± 1.67 × 108 per 106 cycles was determined. ConclusionBackside wear was estimated to be several times lower than published values of articulating wear. However, polyethylene backside wear particles represented significantly smaller particles with partly roughened outlines than articulating wear particles and may therefore cause higher biological response in macrophage-mediated bone resorption compared to articulated particles. Statement of SignificanceWithin this study, an analytical method for quantitative measuring polyethylene backside wear of artificial hip cups was successfully developed and validated for the first time.It could be shown that backside wear is still present, even in modern cup-systems. These findings can be further used for investigations of the osteolytic potential of polyethylene particles, for evaluating and improving new implant systems and to evaluate the effectiveness of screw hole plugs to prevent the particle migration to the acetabulum.

Experimental Characterization of the Primary Stability of Acetabular Press-Fit Cups with Open-Porous Load-Bearing Structures on the Surface Layer

Background: Nowadays, hip cups are being used in a wide range of design versions and in an increasing number of units. Their development is progressing steadily. In contrast to conventional methods of manufacturing acetabular cups, additive methods play an increasingly central role in the development progress. Method: A series of eight modified cups were developed on the basis of a standard press-fit cup with a pole flattening and in a reduced version. The surface structures consist of repetitive open-pore load-bearing textural elements aligned right-angled to the cup surface. We used three different types of unit cells (twisted, combined and combined open structures) for constructing of the surface structure. All cups were manufactured using selective laser melting (SLM) of titanium powder (Ti6Al4V). To evaluate the primary stability of the press fit cups in the artificial bone cavity, pull-out and lever-out tests were conducted. All tests were carried out under exact fit conditions. The closed-cell polyurethane (PU) foam, which was used as an artificial bone cavity, was characterized mechanically in order to preempt any potential impact on the test results. Results and conclusions: The pull-out forces as well as the lever moments of the examined cups differ significantly depending on the elementary cells used. The best results in pull-out forces and lever-out moments are shown by the press-fit cups with a combined structure. The results for the assessment of primary stability are related to the geometry used (unit cell), the dimensions of the unit cell, and the volume and porosity responsible for the press fit. Corresponding functional relationships could be identified. The findings show that the implementation of reduced cups in a press-fit design makes sense as part of the development work.

Early shape change behaviour of an uncemented contemporary hip cup: A cadaveric experiment replicating host bone behaviour through temperature control.

Modular uncemented acetabular components are in common use. Fixation is dependent upon press-fit but the forces necessary to achieve initial stability of the construct at implantation may deform the shell and prevent optimal seating of the polyethylene liner insert. Previous work using single-time point measurements in uncontrolled ambient temperature poorly replicates the native state. A controlled study was performed to observe the time-dependent behaviour of an uncemented acetabular shell in the early phase after implantation into the human acetabulum at near physiological temperature. Using a previously validated cadaveric hip model at controlled near physiological temperature with standardised surgical technique, immediate and delayed shell geometry was determined. Eight custom made 3-mm-thick titanium alloy (TiAl6V4) shells were implanted into four cadavers (eight hips). Time-dependent shell deformation was determined using the previously validated ATOS Triple Scan III (ATOS) optical measurement system. The pattern of change in the shape of the surgically implanted shell was measured at three time points after insertion. We found a consistent pattern for quantitative and directional deformation of the shells. In addition, there was consistency for relaxation of the deformation with time. Immediate mean change in shell radius was 104 µm (standard deviation 32, range 67-153) relaxing to mean 96 µm (standard deviation 32, range 63-150) after 10 min and mean 92 µm (standard deviation 28, range 66-138) after 20 min. The clinical significance of this work is the finding of a time-dependent early deformation of acetabular titanium shells on insertion adjusted for near physiological temperature-controlled host bone.

A novel approach to determine primary stability of acetabular press-fit cups.

Today hip cups are used in a large variety of design variants and in increasing numbers of units. Their development is steadily progressing. In addition to conventional manufacturing methods for hip cups, additive methods, in particular, play an increasingly important role as development progresses. The present paper describes a modified cup model developed based on a commercially available press-fit cup (Allofit 54/JJ). The press-fit cup was designed in two variants and manufactured using selective laser melting (SLM). Variant 1 (Ti) was modeled on the Allofit cup using an adapted process technology. Variant 2 (Ti-S) was provided with a porous load bearing structure on its surface. In addition to the typical (complete) geometry, both variants were also manufactured and tested in a reduced shape where only the press-fit area was formed. To assess the primary stability of the press-fit cups in the artificial bone cavity, pull-out and lever-out tests were carried out. Exact fit conditions and two-millimeter press-fit were investigated. The closed-cell PU foam used as an artificial bone cavity was mechanically characterized to exclude any influence on the results of the investigation. The pull-out forces of the Ti-variant (complete-526 N, reduced-468 N) and the Ti-S variant (complete-548 N, reduced-526 N) as well as the lever-out moments of the Ti-variant (complete-10 Nm, reduced-9.8 Nm) and the Ti-S variant (complete-9 Nm, reduced-7.9 N) show no significant differences in the results between complete and reduced cups. The results show that the use of reduced cups in a press-fit design is possible within the scope of development work.