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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 133 - 133
1 Feb 2020
Borjali A Chen A Muratoglu O Varadarajan K
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INTRODUCTION

Mechanical loosening of total hip replacement (THR) is primarily diagnosed using radiographs, which are diagnostically challenging and require review by experienced radiologists and orthopaedic surgeons. Automated tools that assist less-experienced clinicians and mitigate human error can reduce the risk of missed or delayed diagnosis. Thus the purposes of this study were to: 1) develop an automated tool to detect mechanical loosening of THR by training a deep convolutional neural network (CNN) using THR x-rays, and 2) visualize the CNN training process to interpret how it functions.

METHODS

A retrospective study was conducted using previously collected imaging data at a single institution with IRB approval. Twenty-three patients with cementless primary THR who underwent revision surgery due to mechanical loosening (either with a loose stem and/or a loose acetabular component) had their hip x-rays evaluated immediately prior to their revision surgery (32 “loose” x-rays). A comparison group was comprised of 23 patients who underwent primary cementless THR surgery with x-rays immediately after their primary surgery (31 “not loose” x-rays). Fig. 1 shows examples of “not loose” and “loose” THR x-ray. DenseNet201-CNN was utilized by swapping the top layer with a binary classifier using 90:10 split-validation [1]. Pre-trained CNN on ImageNet [2] and not pre-trained CNN (initial zero weights) were implemented to compare the results. Saliency maps were implemented to indicate the importance of each pixel of a given x-ray on the CNN's performance [3].


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 114 - 114
1 Apr 2019
Chaudhary M Muratoglu O Varadarajan KM
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INTRODUCTION

Ceramic heads are used in hip revision surgery to mitigate corrosion concerns. Manufacturers recommend using a pristine titanium sleeve in conjunction with a well-fixed metal stem to prevent early failure of the ceramic head. However, the influence of impact force, head size, and sleeve offset on pull-off strength and seating displacement of a revision head assembly is not fully understood. Therefore, the purpose of this study was to investigate the pull-off strength and displacement of commercially available revision ceramic heads and titanium taper sleeve offsets (BIOLOX OPTION, CeramTec GmbH, Plochingen, Germany) while covering a range of clinically relevant impaction forces.

METHODS

Two head sizes (28 mm, n = 12 and 36 mm, n = 12) and two taper adapter sleeve offsets (small, n = 12 and extra-large, n =12) were tested in this study. A dynamic impaction rig was constructed to seat the head, sleeve, and stem assembly. Consistent impaction forces were achieved by a dropping a hammer fixed to a lever arm from a pre-determined height onto a standard impactor instrumented with a piezoelectric force sensor (PCB Piezotronics Inc.). Axially applied forces of 2 kN and 6 kN were used to cover a range of typical impaction forces. Three non-contact differential variable reluctance transducers (LORD Sensing Systems) were used to track the displacement of the head relative to the stem. Subsequently, samples were transferred a servo hydraulic testing machine, and a pull-off test was carried out per ISO 7206- 10 to measure the disassembly force.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 82 - 82
1 Apr 2019
Boruah S Husken L Muratoglu O Varadarajan KM
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As an alternative to total hip arthroplasty (THA), hip resurfacing arthroplasty (HRA) provides the advantage of retaining bone stock. However, femoral component loosening and femoral neck fracture continue to be leading causes of revision in HRA. Surgical technique including cementation method and bone preparation, and patient selection are known to be important for fixation. This study was designed to understand if and to what extent compromise in bone quality and the presence of cysts in the proximal femur contribute to resurfacing component loosening.

A finite element (FE) model of a proximal femur was used to calculate the stress in the cement layer. Bone density to Young's modulus relationship was used to calibrate the bone stiffness in the model using computed tomography. A contemporary resurfacing implant (BHR, Smith & Nephew) was used in the FE model. The effect of reduced bone quality (35% reduction relative to normal baseline; osteoporosis threshold) and presence of cysts on stress in the bone cement layer was then assessed using the same FE model. The center of the cyst (a localized spherical cavity 1 cm in diameter) was located directly under the contact patch. Simulations were run with two locations of the center of the cyst, on the surface of the resected bone and 1 cm below it. The surface cyst was filled with bone cement, but the inner cyst was empty. The contact force and location for the model were obtained from instrumented implant studies. Simulations were run representing the peak loads during two activities, jogging and stand-up from seated position.

While density reduction of the bone reduced the stress in the CoCr femoral head, the Von-Mises stress in the cement layer was amplified. The peak Von-Mises stress in the cement layer under the contact patch increased more than six times for the jogging activity, and more than ten times for the stand-up activity, relative to values for normal bone density. The impact of cysts on the cement layer stress or the strain distributions in the bone were minimal.

The results show a greater risk of failure of the cement layer under conditions of reduced bone density. In contrast cement stresses and bone strains appeared to be relatively immune to a surface cyst filled with bone cement or an empty inner cyst. Contraindications of hip resurfacing include severe osteopenia and multiple cysts of the femoral head, however no strict or quantitative criteria exist to guide patient selection. Research similar to the one presented herein, maybe key to developing better patient selection criteria to reduce risk associated with compromised femoral head fixation.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 87 - 87
1 Apr 2019
Boruah S Muratoglu O Varadarajan KM
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Posterior stabilized (PS) total knee arthroplasty (TKA), wherein mechanical engagement of the femoral cam and tibial post prevents abnormal anterior sliding of the knee, is a proven surgical technique. However, many patients complain about abnormal clicking sensation, and several reports of severe wear and catastrophic failure of the tibial post have been published. In addition to posterior cam-post engagement during flexion, anterior engagement with femoral intercondylar notch can also occur during extension. The goal of this study was to use dynamic simulations to explore sensitivity of tibial post loading to implant design and alignment, across different activities.

LifeModeler KneeSIM software was used to calculate tibial post contact forces for four contemporary PS implants (Triathlon PS, Stryker; Journey BCS and Legion PS, Smith & Nephew; LPS Flex, Zimmer Biomet). An average model of the knee, including cartilage and soft tissue insertion locations, created from MRI data of 40 knees was used to mount and align the component. The Triathlon femoral component was mounted with posterior and distal condylar tangency at: a) both medial and lateral condylar cartilage (anatomic alignment), b) at the medial condylar cartilage and perpendicular to mechanical axis (mechanical alignment with medial tangency), and c) at lateral condylar cartilage and perpendicular to mechanical axis (mechanical alignment with lateral tangency). The influence of implant design was assessed via simulations for the other implant systems with the femoral components aligned perpendicular to mechanical axis with lateral tangency. Five different activities were simulated.

The anterior contact force was significantly smaller than the posterior contact force, but it varied noticeably with tibial insert slope and implant design. For Triathlon PS, during most activities anatomic alignment of the femoral component resulted in greater anterior contact force compared to mechanical alignment, but absolute magnitude of forces remained small (<100N). Mechanical alignment with medial tangency resulted in greater posterior contact force for deep knee bend and greater anterior force for chair sit activity. For all implants, peak posterior contact forces were greater for activities with greater peak knee flexion. The magnitude of posterior contact forces for the various implants was comparable to other reports in literature. Overall activity type, implant design and slope had greater impact on post loading than alignment method.

Tibial insert slope was shown to be important for anterior post loading, but not for posterior post loading. Anatomic alignment could increase post loading with contemporary TKA systems. In the case of the specific design for which effect of alignment was evaluated, the changes in force magnitude with alignment were modest (<200N). Nonetheless, results of this study highlight the importance of evaluating the effect of different alignment approaches on tibial post loading.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 91 - 91
1 Apr 2019
Chaudhary M Muratoglu O Varadarajan KM
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INTRODUCTION

Postoperative functional limitations after Total Knee Arthroplasty (TKA) are caused, in part, by a mismatch between a patient's natural anatomy and conventional “off-the-shelf” implants. To address this, we propose a new concept combining off-the-shelf femur and tibia implants with custom polyethylene tibial inserts designed to account for a patient's unique anatomy. Our goal in this study was to use knee specific computational modeling to determine the neutral path of motion and laxity of an intact knee under axial compression and shear forces through full flexion and compare intact motion against the same knee implanted with a conventional off-the-shelf vs. a custom tibial insert.

METHODS

3D models of a healthy knee joint were acquired from an open development repository funded by the National Institute of Biomedical Imagining and Bioengineering (Harris et al., 2016). The knee model was virtually implanted with conventional (off-the-shelf) posterior cruciate retaining (CR) components including the femoral component, tibial tray, and a conventional insert. A custom CR tibial insert was designed taking into account native articular geometry and compatibility with placement of the off-the-shelf femoral/tibial tray. Bone, cartilage and implant models were imported into ANSYS Workbench. Ligaments were calibrated using data from in-vitro experimental tests (Harris et al., 2016). The following load conditions were applied to the femur: 20 N axial compression (neutral path), 20 N axial compression with 80 N anterior shear force, and 20 N axial compression with 80 N posterior shear force. Simultaneously for each loading condition, the knee was flexed from 0 – 120 degrees. A circular axis system was used to describe the motion of the femur relative to the tibia.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 39 - 39
1 Mar 2017
Muratoglu O Oral E Doshi B
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Introduction

Radiation cross-linked UHMWPE is preferred in total hip replacements due to its wear resistance [1]. In total knees, where stresses are higher, there is concern of fatigue damage [2]. Antioxidant stabilization of radiation cross-linked UHMWPE by blending vitamin E into the polymer powder was recently introduced [3]. Vitamin E greatly hinders radiation cross-linking in UHMWPE [4]. In contrast peroxide cross-linking of UHMWPE is less sensitive to vitamin E concentration [5]. In addition, exposing UHMWPE to around 300°C, increases its toughness by inducing controlled chain scission and enhanced intergranular diffusion of chains, simultaneously [6]. We present a chemically cross-linked UHMWPE with high vitamin E content and improved toughness by high temperature melting.

Methods and Materials

Medical grade GUR1050 UHMWPE was blended with vitamin E and with 2,5-Di(tert-butylperoxy)-2,5-dimethyl-3-hexyne or P130 (0.5% Vitamin-E and 0.9% P130). The mixed powder was consolidated into pucks. The pucks were melted for 5 hours in nitrogen at 300, 310 and 320°C.

One set of pucks melted at 310°C was accelerated aged at 70°C at 5 atm. oxygen for 2 weeks.

Tensile mechanical properties were determined using ASTM D638. Izod impact toughness was determined using ASTM D256 and F648. Wear rate was determined using a bidirectional pin-on-disc (POD) tester with cylindrical pins of UHMWPE against polished CoCr discs in undiluted, preserved bovine serum.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 126 - 126
1 Mar 2017
Zumbrunn T Duffy M Rubash H Malchau H Muratoglu O Varadarajan KM
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One of the key factors responsible for altered kinematics and joint stability following contemporary total knee arthroplasty (TKA) is resection of the anterior cruciate ligament (ACL). Therefore, retaining the ACL is often considered to be the “holy grail” of TKA. However, ACL retention can present several technical challenges, and in some cases may not be viable due to an absent or non-functional ACL. Therefore, the goal of this research was to investigate whether substitution of ACL function through an anterior post mechanism could improve kinematic deficits of contemporary posterior cruciate ligament (PCL) retaining (CR) implants. This was done using KneeSIM, a previously established dynamic simulation tool based on an Oxford-rig setup. Deep knee bend, chair-sit, stair-ascent and walking were simulated for a contemporary ACL sacrificing (CR) implant, two ACL retaining implants, and an ACL substituting and PCL retaining implant. The motion of the femoral condyles relative to the tibia was recorded for kinematic comparisons.

Our results revealed that, like ACL retaining implants, the ACL substituting implant could also provide kinematic improvements over contemporary ACL sacrificing implants by reducing early posterior femoral shift and preventing paradoxical anterior sliding. Such ACL substituting implants may be a valuable addition to the armament of joint surgeons, allowing them to provide improved knee function even when ACL retention is not feasible. Further research is required to investigate this mechanism in vitro and in vivo to verify the results of the simulations, and to determine whether kinematic improvements translate into improved clinical outcomes.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 69 - 69
1 Mar 2017
Muratoglu O Oral E Suhardi V Bichara D Rubash H Freiberg A Malchau H
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Introduction

Radiation cross-linking of ultrahigh molecular weight polyethylene (UHMWPE) has reduced the in vivo wear and osteolysis associated with bearing surface wear (1), significantly reducing revisions associated with this complication (2). Currently, one of the major and most morbid complications of joint arthroplasty is peri-prosthetic infection (3). In this presentation, we will present the guiding principles in using the UHMWPE bearing surface as a delivery device for therapeutic agents and specifically antibiotics. We will also demonstrate efficacy in a clinically relevant intra-articular model.

Materials and Methods

Medical grade UHMWPE was molded together with vancomycin at 2, 4, 6, 8, 10 and 14 wt%. Tensile mechanical testing and impact testing were performed to determine the effect of drug content on mechanical properties. Elution of the drug was performed in phosphate buffered saline (PBS) for up to 8 weeks and the detection of the drug in PBS was done by UV-Vis spectroscopy. A combination of vancomycin and rifampin in UHMWPE was developed to address chronic infection and layered construct containing 1 mm-thick drug-containing UHMWPE in the non-load bearing regions was developed for delivery. In a lapine (rabbit) intra-articular model (n=6 each), two plug of the layered UHMWPE construct were placed in the trochlear grove of the rabbit femoral surface and a porous titanium rod with a pre-grown biofilm of bioluminescent S. Aureus was implanted in the tibia. Bioluminescent imaging was employed to visualize and quantify the presence of the bacteria up to 3 weeks.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 25 - 25
1 Mar 2017
Muratoglu O Suhardi V Bichara D Bedair H Oral E
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Introduction

The use of narcotic medications to manage postoperative pain after TJA has been associated with impaired mobility, diminished capacity to engage in rehabilitation, and lower patient satisfaction [1]. In addition, side effects including constipation, dizziness, nausea, vomiting and urinary retention can prolong post-operative hospital stays. Intraarticular administration of local anesthetics such as bupivacaine – part of a multimodal postoperative pain management regimen – reduces pain and lowers patients' length of stay [2]. In addition to its anesthetic activity, bupivacaine also has antibacterial activity, particularly against gram-positive bacteria [3]. We have developed a bupivacaine-eluting ultrahigh molecular weight polyethylene (Bupi-PE) formulation; we hypothesized that elution of bupivacaine from polyethylene could have both anesthetic and antibacterial effects in vivo.

Methods


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 26 - 26
1 Mar 2017
Muratoglu O Suhardi V Bichara D Kwok S Freiberg A Rubash H Yun S Oral E
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Introduction

About 2% of primary total joint replacement arthroplasty (TJA) procedures become infected. Periprosthetic joint infection (PJI) is currently one of the main reasons requiring costly TJA revisions, posing a burden on patients, physicians and insurance companies.1 Currently used drug-eluting polymers such as bone cements offer limited drug release profiles, sometimes unable to completely clear out bacterial microorganisms within the joint space. For this study we determined the safety and efficacy of an antibiotic-eluting UHMWPE articular surface that delivered local antibiotics at optimal concentrations to treat PJI in a rabbit model.

Materials and Methods

Skeletally mature adult male New Zealand White rabbits received either two non-antibiotic eluting UHMWPE (CONTROL, n=5) or vancomycin-eluting UHMWPE (TEST, n=5) (3 mm in diameter and 6 mm length) in the patellofemoral groove (Fig. 1). All rabbits received a beaded titanium rod in the tibial canal (4 mm diameter and 12 mm length). Both groups received two doses of 5 × 107 cfu of bioluminescent S. aureus (Xen 29, PerkinElmer 119240) in 50 µL 0.9 % saline in the following sites: (1) distal tibial canal prior to insertion of the rod; (2) articular space after closure of the joint capsule (Fig. 1). None of the animals received any intravenous antibiotics for this study. Bioluminescence signal (photons/second) was measured when the rabbits expired, or at the study endpoint (day 21). The metal rods were stained with BacLight® Bacterial Live-Dead Stain and imaged using two-photon microscopy to detect live bacteria. Hardware, polyethylene implants and joint tissues were sonicated to further quantify live bacteria via plate seeding.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 9 - 9
1 Mar 2017
Wannomae K Micheli B Konsin Z Muratoglu O
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Introduction

Oxidation of ultrahigh molecular weight polyethylene (UHMWPE) can lead to failure of implants used in total joints. Cyclic loading is postulated to be one mechanism of in vivo oxidation in UHMWPE components as one previous study has shown [1]. We developed an accelerated aging test that incorporated compressive cyclic loading that the UHMWPE components would be exposed to in vivo. Surgeons are moving towards larger femoral heads in hip arthroplasty and removing less bone in knee arthroplasty necessitating thinner UHMWPE components. We hypothesized that, in this accelerated aging test, thinner UHMWPE components would be more susceptible to oxidation caused by the cyclic loading due to higher stresses in the material.

Materials and Methods

All samples tested in this study were Conventional PE: GUR1050 was machined into test specimens, vacuum packaged and gamma sterilized. Test samples were blocks 100 mm × 89 mm in cross-section with 3 different thicknesses: 1 mm, 3 mm, and 10 mm (n=3 each). Three cylinders were cored out of each test sample to serve as controls (Fig 1a) that were physically separated and thereby isolating the oxidation attributable to an applied compressive cyclic load. The controls were placed back into the holes from where they were cored during testing. Compressive loading was administered by a 12.5 mm diameter applicator affixed to a hydraulic test frame (Fig 1b), and all testing was done at 80°C in air. A sinusoidal compressive cyclic stress between 1 and 10 MPa was applied at 5 Hz for 7 days.

Microtomed thin films from all samples were analyzed via Fourier Transform Infrared Spectroscopy (FTIR) to quantify oxidation [2] after testing. Oxidation was measured through the thickness of the sample at targeted points along the length from directly underneath the center of the load applicator to 10mm away (Fig 1a). Oxidation was also measured through the thickness of the cylindrical controls.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 10 - 10
1 Mar 2017
Micheli B Wannomae K Muratoglu O
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Introduction

The fatigue strength of ultrahigh molecular weight polyethylene (UHMWPE) in total joint implants is crucial to its long term success in high demand applications, such as in the knee, and is typically determined by measuring the crack propagation resistance in razor-notched specimens under cyclic load [1]. This only tells part of the story: that is, how well the material resists crack propagation once a crack is present. A second, equally important component of fatigue strength is how well the material resists crack formation. Previous studies cyclically loaded a cantilevered post until failure [2], postulating that the post would break very quickly after crack initiation. Parran et. al. proposed a novel method to measure the crack initiation time by holding a sample in constant tension until a crack was visually observed [3]. We hypothesize that the crack initiation times of various UHMWPEs will follow similar trends as the more omnipresent crack propagation resistance tests.

Materials and Methods

The following UHMWPE formulations were tested: (i) virgin, (ii) gamma sterilized in vacuum, (iii) 91 kGy gamma irradiated, and (iv) 91 kGy gamma irradiated and subsequently melted. GUR1020 and GUR1050 bar stock of varying irradiation doses were machined into compact tension specimens [4] with a notch depth of 17 mm and a blunt notch root radius of 0.25 mm, mimicking a geometry of a joint replacement component.

Specimens were held in constant tension until failure; 3 to 5 different loads between 1 kN and 2.25 kN (n=3 samples per load per material) were tested. A video camera was focused on the face of the notch and took a picture every 10 seconds. The photos were reviewed to manually determine the crack initiation time (Fig 1). The time it took for the sample to completely fail – that is, shear into two separate pieces – was also recorded.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 80 - 80
1 Mar 2017
Wannomae K Lozynsky A Konsin Z Muratoglu O
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Introduction

Corrosion of the femoral head-trunnion junction in modular hip components has become a concern as the corrosion products may lead to adverse local tissue reactions. A simple way to avoid trunnion corrosion is to manufacture the femoral head with a non-metallic material, such as ceramics that are widely. An alternative solution may lie in advanced polymers like polyaryletherketones (PAEKs). These thermoplastics have high mechanical strength necessary for use as femoral heads in hip arthroplasty, but they must be tested to ensure that they do not adversely affect the wear of the ultrahigh molecular weight polyethylene (UHMWPE) liner counterface. Pin-on-disc (POD) wear testing has been extensively used to evaluate the wear properties of UHMWPE prior to more extensive and costly analysis with joint simulators. We hypothesized that the wear of crosslinked UHMWPE would not be adversely affected in POD tests when articulated against an advanced thermoplastic counterface.

Methods

0.1 wt.% VitE blended UHMWPE stock was e-beam irradiated to 100, 125, 140, 160, and 175 kGy and machined into cylindrical pins for testing. An additional group of 100 kGy e-beam irradiated and melted UHMWPE (with no vitamin E) was also machined and tested.

Three different counterface materials were tested: (1) Cobalt-chrome (CoCr) with a surface roughness (Ra) of <0.5 μm, (2) Biolox™ ceramic (CeramTec), and (3) Polyetheretherketone (PEEK), a member of the PAEK family (Fig 1).

A bidirectional POD wear tester [1] was used to measure the wear rate of UHMWPE specimens, where the specimens moved in a 10 mm × 5 mm rectangular pattern under a Paul-type load curve [2] synchronized with the motion. The peak load of the loading curve corresponded to a peak contact pressure of 5.1 MPa between each UHMWPE pin specimen and the counterface disc. Each test was conducted at 2 Hz in undiluted bovine serum stabilized with ethylenediamine tetraacetate (EDTA) and penicillin. The pins were cleaned and weighed daily, and a wear rate was calculated at the end of each test by linear regression.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 135 - 135
1 Feb 2017
Varadarajan KM Patel R Zumbrunn T Rubash H Malchau H Freiberg A Muratoglu O
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Introduction

Dual-mobility (DM) liners provide increased range of motion and stability. However, large head diameters have been associated with anterior hip pain due to impingement with surrounding soft-tissues, particularly the iliopsoas. Further, during hip extension the liner can get trapped due to anterior soft-tissue impingement that resists rotation being imparted to the liner from posterior stem-liner contact. Over time this can cause liner rim damage, leading to intra-prosthetic dislocation of the small diameter inner head. To address this, an anatomically contoured dual mobility (ACDM) liner was designed to reduce the volume of the liner below the equator that can interact with soft-tissues (Fig. 1). In this study, we utilized finite element analysis to evaluate tendon-liner contact pressure and tendon stresses with ACDM and conventional designs during hip extension, wherein the posterior edge of liner is in contact with the stem while the anterior edge is exposed to the soft-tissue.

Methods

The average uniaxial stiffness (350 N/mm), and average dimensions (width × thickness = 14mm × 4mm) of 10 cadaver psoas tendon samples were determined in a separate study. The iliopsoas tendon was modelled as a Yeoh hyper-elastic material, and the material constants were tuned to match the experimental uniaxial test data. Cadaver specific FEA models were created for 5 specimens (10 hips) using computed tomography (CT) scans. The implant components were modeled as being rigid relative to the iliopsoas tendon. The iliopsoas tendon was modelled as extending from its insertion point on the lesser trochanter to the psoas notch on the pelvis for hip flexion angles of −15°, 0°, 15° and 30°. Appropriately sized DM components were implanted virtually for each specimen. Once placed in its proper position, the liner was rotated about the flexion axis until it contacted the stem posteriorly to represent its orientation during hip extension (Fig. 2). A 500N tensile load was applied to the iliopsoas tendon and the average/max stresses within the tendon, and average/max contact pressures between the tendon and liner were measured.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 43 - 43
1 Feb 2017
Muratoglu O Bichara D O'Brien C Doshi B Oral E
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Introduction

We have previously demonstrated that peroxide crosslinked vitamin E-blended UHMWPE maintains its clinically-required wear and mechanical properties [1]. This material can potentially be used as an irradiation-free bearing surface for TJA. However, using organic peroxides in medical devices requires a thorough examination of tissues in contact with the implant. For this study we crosslinked polyethylene using five times the needed concentration of peroxide (2,5-Dimethyl-2,5-di(t-butylperoxy)-hexyne-3 or P130), followed by implantation to determine implant biocompatibility, and pre and post implant peroxide residual contents.

Methods

The study was performed after institutional approval following ISO standard 10993–6. Study groups: not crosslinked (0.2 (1050) VE), crosslinked (0.2 VE (1050)/5% P130) and crosslinked-high temperature melted (HTM) (0.2 VE (1050)/5% P130). Materials were blended and consolidated, machined (2.5 diameter × 2.5 cm height), sterilized and implanted in the dorsum New Zealand white rabbits. Pre and post implantation FTIR was performed. Two samples were implanted in each rabbit; n=6 samples were included for each group. After 4 weeks, samples were explanted, analyzed using FTIR, and subcutaneous tissues processed for histological analysis.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 99 - 99
1 Feb 2017
Bragdon C Hussey D Madanat R Donahue G Rolfson O Muratoglu O Malchau H
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Introduction

When following patients with metal-on-metal (MoM) hip replacements, current evidence suggests that orthopaedic surgeons should avoid reliance on any single investigative tool. In 2014, guidelines for stratifying patients with MoM hip replacement into groups of low, medium, and high risk of failure based on multiple criteria were published. However, such risk stratification guidelines can be difficult to interpret due to the numerous risk factors related to MoM hip replacements. This is especially true for patients with various (high and low) risk levels for different criteria within the guidelines.

The first purpose of this study was to assess if a scoring system can be applied to the current MoM guidelines. The second purpose was to test, using this scoring system, how the contemporary guidelines would classify a cohort of patients with a recalled MoM hip replacement system.

Methods

The study population consisted of 1301 patients (1434 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study of a recalled MoM hip replacement system at a mean of 6.2 (range 2.4 – 11.2) years from index surgery. Eleven required scoring criteria were determined based on existing follow-up algorithm recommendations and consisted of patient factors, symptoms, clinical status, implant type, metal ion levels, and radiographic imaging results. Criteria considered ‘low’ risk were given 1 point, 2 points for ‘moderate’ risk, and 3 points for the ‘high’ risk group. Forward stepwise logistic regression was conducted to determine the minimum set of predictive variables for risk of revision and assign variable weights. The MoM risk score for each hip was then created by averaging the weighted values of each predictive variable.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 100 - 100
1 Feb 2017
Bragdon C Donahue G Lindgren V Galea V Madanat R Muratoglu O Malchau H
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Introduction

Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA.

The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA.

Methods

The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 67 - 67
1 Feb 2017
Muratoglu O Chen W Suhardi V Bichara D
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Introduction

Periprosthetic joint infection (PJI) and particle-induced osteolysis are closely related to peri-implant local immunity and macrophage function. We previously demonstrated that titanium particles attenuate the immune response of macrophages caused by chronic inflammation [1]. In a separate study, we have determined that UHMWPE wear particles containing vitamin E (VE) induce less osteolysis compared to HXL UHMWPE wear particles in a murine calvarium model [2]. For this study we hypothesized that macrophages exposed to HXL UHMWPE particles containing VE would better maintain their ability to respond to S. aureus compared to HXL UHMWPE without VE.

Methods

A gamma-sterilized, HXL UHMWPE tibial bearing containing VE (E1, Biomet, “VE-PE”) and 100kGy irradiated and melted UHMWPE (“CISM 100”) were cryomilled to particles by Bioengineering Solutions (Oak Park, IL). In the first in vitro study, RAW 264.7 mouse macrophages were exposed (inverted co-culture) to either VE-PE particles or CISM100 particles and lipopolysaccharide (LPS) for 1–7 days. Macrophage viability was measured using a cell counting kit (CCK-8). Control group with no particles and a LPS group were also included. Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) staining was performed to determine macrophage apoptosis rate in response to particle exposure over time. In the second study, macrophages were exposed to VE-PE or CISM100 particles for 48h, then exposed to LPS for 30 min. Subsequently, reactive oxygen species (ROS) generation and extracellular regulated protein kinase (ERK) phosphorylation were measured. In a third study, after exposure to particles for 48h, fatigued macrophages were co-cultured with bioluminescent S. aureus strain Xen29 for 3h and 6h. Bioluminescence signal was determined to measure the total amount of bacteria. Bacterial live/dead staining and optical density at 600 nm (OD 600) were also performed to determine S. aureus viability. Statistical analysis was performed using one-way or two-way ANOVA with a post hoc examination. *indicates p<0.05.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 128 - 128
1 Feb 2017
Bragdon C Galea V Donahue G Lindgren V Troelsen A Marega L Muratoglu O Malchau H
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Introduction

Studies of metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) have reported high complication and failure rates due to elevated metal ion levels. These rates were shown to be especially high for the Articular Surface Replacement (ASR) HRA, possibly due to its unique design. Associations between metal ion concentrations and various biological and mechanical factors have been reported. Component positioning as measured by acetabular inclination has been shown to be of especially strong consequence in metal ion production in ASR HRA patients, but few studies have evaluated acetabular anteversion as an independent variable.

The primary objective of this study was to evaluate the associations between component orientation, quantified by acetabular inclination and anteversion, and blood metal ions. Secondly, we sought to report whether conventional safe zones apply to MoM HRA implants or if these implants require their own positioning standards.

Methods

We conducted a multi-center, prospective study of 512 unilateral ASR HRA patients enrolled from September 2012 to June 2015. At time of enrollment our patients were a mean of 7 (3–11.5) years from surgery. The mean age at surgery was 56 years and 24% were female. All subjects had complete demographic and surgical information and blood metal ions. In addition, each patient had valid AP pelvis and shoot-though lateral radiographs read by 5 validated readers measuring acetabular abduction and anteversion, and femoral offset. A multivariate logistic regression was used with high cobalt or chromium (greater than or equal to 7ppb) as the dependent variable. The independent variables were: female gender, UCLA activity score, age at surgery, femoral head size, time from surgery, femoral offset, acetabular abduction, and acetabular anteversion.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 154 - 154
1 May 2016
Zumbrunn T Varadarajan K Rubash H Malchau H Li G Muratoglu O
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INTRODUCTION

In native knees anterior cruciate ligament (ACL) and asymmetric shape of the tibial articular surface with a convex lateral plateau are responsible for differential medial and lateral femoral rollback. Contemporary ACL retaining total knee arthroplasty (TKA) improves knee function over ACL sacrificing (CR) TKA; however, these implants do not restore the asymmetric tibial articular geometry. This may explain why ACL retention addresses paradoxical anterior sliding seen in CR TKA, but does not fully restore medial pivot motion. To address this, an ACL retaining biomimetic implant, was designed by moving the femoral component through healthy in vivo kinematics obtained from bi-planar fluoroscopy and sequentially removing material from a tibial template. We hypothesized that the biomimetic articular surface together with ACL preservation would better restore activity dependent kinematics of normal knees, than ACL retention alone.

METHODS

Kinematic performance of the biomimetic BCR design (asymmetric tibia with convex lateral surface), a contemporary BCR implant (symmetric shallow dished tibia) and a contemporary CR implant (symmetric dished tibia) was analyzed using KneeSIM software. Chair-sit, deep knee bend, and walking were analyzed. Components were mounted on an average bone model created from magnetic resonance imaging (MRI) data of 40 normal knees. Soft-tissue insertions were defined on the average knee model based on MRI data, and mechanical properties were obtained from literature. Femoral condyle center motions relative to the tibia were tracked to compare different implant designs.