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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 36 - 36
1 Feb 2021
Spece H Kurtz S Yu T Marcolongo M Law A
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Introduction

The ability to create patient-specific implants (PSI) at the point-of-care has become a desire for clinicians wanting to provide affordable and customized treatment. While some hospitals have already adopted extrusion-based 3D printing (fused filament fabrication; FFF) for creating non-implantable instruments, recent innovations have allowed for the printing of high-temperature implantable polymers including polyetheretherketone (PEEK). With interest in FFF PEEK implants growing, it is important to identify methods for printing favorable implant characteristics such as porosity for osseointegration.

In this study, we assess the effect of porous geometry on the cell response and mechanical properties for FFF-printed porous PEEK. We also demonstrate the ability to design and print customized porous implants, specifically for a sheep tibial segmental defect model, based on CT images and using the geometry of triply periodic minimal surfaces (TPMS).

Methods

Three porous constructs – a rectilinear pattern and gyroid/diamond TPMSs – were designed to mimic trabecular bone morphology and manufactured via PEEK FFF. TPMSs were designed by altering their respective equation approximations to achieve desired porous characteristics, and the meshes were solidified and shaped using a CAD workflow. Printed samples were mCT scanned to determine the resulting pore size and porosity, then seeded with pre-osteoblast cells for 7 and 14 days. Cell proliferation and alkaline phosphatase activity (ALP) were evaluated, and the samples were imaged via SEM. The structures were tested in compression, and stiffness and yield strength values were determined from resulting stress-strain plots. Roughness was determined using optical profilometry. Finally, our process of porous structure design/creation was modified to establish a proof-of-concept workflow for creating PSIs using geometry established from segmented sheep tibia CT images.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 58 - 58
1 Oct 2020
Mihalko WM Heise G Morrow B Arnholt C Kurtz S
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Introduction

Pitting damage on implants has been reported and attributed to use of electrocautery. This study aimed to distinguish how different TKA bearing surfaces are susceptible to this type of damage and whether surgeons were aware that this damage can occur.

Methods

A survey was sent to Hip and Knee Society members to determine what percentage of adult reconstructive surgeons use electrocautery after implantation of components. Three bearing surfaces for primary TKA were selected: CoCr, Oxinium, and zirconium nitride (ZrN) to be damaged by electrocautery with a monopolar (MP, Bovie) and bipolar (BP, Aquamantys) electrocautery with three different energy settings. A comparison of surface damage and backscatter elemental analysis using SEM was performed. Average roughness (Ra), maximal peak-to-valley height (Rz,), kurtosis (Rk), and skewness (Rsk) measurements were collected using a profilometer (DektakXT, Bruker, Tucson, AZ) with a 2.5µm radius stylus to assess an area of 3.8mm by 3.2mm in the central portion of the area for each MP and BP energy setting used to impart damage to the bearing surfaces. A similar undamaged area for each bearing surface was also measured for roughness parameter comparison.


Introduction

The ability to manufacture implants at the point-of-care has become a desire for clinicians wanting to provide efficient patient-specific treatment. While some hospitals have adopted extrusion-based 3D printing (fused filament fabrication; FFF) for creating non-implantable instruments with low-temperature plastics, recent innovations have allowed for the printing of high-temperature polymers such as polyetheretherketone (PEEK). Due to its low modulus of elasticity, high yield strength, and radiolucency, PEEK is an attractive biomaterial for implantable devices. Though concerns exist regarding PEEK for orthopaedic implants due to its bioinertness, the creation of porous networks has shown promising results for bone ingrowth.

In this study, we endeavor to manufacture porous PEEK constructs via clinically-used FFF. We assess the effect of porous geometry on cell response and hypothesize that porous PEEK will exhibit greater preosteoblast viability and activity compared to solid PEEK. The work represents an innovative approach to advancing point-of-care 3D printing, cementless fixation for total joint arthroplasty, and additional applications typically reserved for porous metal.

Methods

Three porous constructs – a rectilinear pattern and two triply period minimal surface (TPMSs) - were designed to mimic the morphology of trabecular bone. The structures, along with solid PEEK samples for use as a control, were manufactured via FFF using PEEK. The samples were mCT scanned to determine the resulting pore size and porosity. The PEEK constructs were then seeded with pre-osteoblast cells for 7 and 14 days. Cell proliferation and alkaline phosphatase activity (ALP) were evaluated at each time point, and the samples were imaged via SEM.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 142 - 142
1 Apr 2019
Higgs G Rimnac C Mihalko W Gilbert J Kurtz S
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Introduction

Corrosion at modular junctions of total hip replacements has been identified as a potential threat to implant longevity, resulting in efforts to determine appropriate countermeasures. Visual scoring and volumetric material loss measurements have been useful tools to elucidate various clinical and design factors associated with corrosion damage. However, corrosion involves electron exchange that results in chemical changes to biomedical alloys, and electrochemical assessment may therefore be a more appropriate approach to understand the phenomenon. The purpose of this pilot study was to electrochemically distinguish the severity of corrosion in retrieved femoral heads. A secondary goal was to identify the potential of electrochemical impedance spectroscopy (EIS) as a method to identify different forms of corrosion damage.

Methods

Twenty femoral heads were identified from a larger study of total hip replacements, obtained as part of an ongoing multi- center IRB-approved retrieval program. Using a previously established 4-point scoring method, components were binned by taper damage: 10 components were identified as having severe damage, 7 with moderate damage and 2 with mild damage. One (1) unimplanted control was included to represent minimal corrosion damage. All components were then characterized using electrochemical impedance spectroscopy under the frequency domain: a 10 mV sinusoidal voltage, ranging from 20 kHz to 2 mHz, was applied to the taper of a femoral head (working electrode) filled with a 1M solution of PBS, a platinum counter electrode and a chlorided silver reference electrode. Absolute impedance at 2 mHz (|Z0.002|), and max phase angle (θ) were assessed relative to taper damage severity. After least-squares fitting of the EIS data to a Randles circuit with a constant phase element, circuit elements: polarization resistance (Rp), CPE-capacitance, and CPE-exponent were also evaluated. The seven (7) most severely corroded components were further examined with scanning electron microscopy to identify corrosion modes. For all statistical analyses, significance was determined at alpha=0.05.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 32 - 32
1 Oct 2018
Sodhi N Anis HK Garbarino LJ Gold PA Sultan AA Kurtz S Rueda CAH Hepinstall MS Mont MA
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Background

Much effort has been aimed at strategies for patient optimization, perioperative standards of care, and postoperative risk stratification to reduce the incidence of SSI. Examples include, newer dressing modalities, antibiotic-impregnated bone cement, intra-wound powdered antibiotics, as well as novel suture types and techniques, all of which have shown great potential. However, the question remains as to whether these changes in practice have led to lower overall infections over the past few years. Therefore, the purpose of this study was to track the annual rates and trends of: 1) overall; 2) deep; and 3) superficial SSI following total hip arthroplasty (THA) using the most recent data (2012 to 2016) from a large nationwide database.

Methods

The National Surgical Quality Improvement Program database was queried for all primary THAs (CPT code 27130) between 2012 and 2016, yielding 122,451 cases. Cases with reported superficial and/or deep SSIs were combined for an overall rate, and then independently analyzed as deep and superficial SSIs. The infection incidence for each year was calculated. After an overall 5-year correlation and trends, univariate analysis was also performed to compare the most recent year, 2016, with each of the preceding 4 years. Furthermore, a comparison of overall and deep SSI incidences from this study were compared to meta-analysis of pooled data from 2001 to 2011. Pearson correlation coefficients and chi-squared tests were used to determine correlation and statistical significance which was maintained at a p-value less than 0.05.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 35 - 35
1 Aug 2018
Garvin K Weisenburger J Kyomoto M Siskey R Kurtz S Haider H
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We report on an innovative surface grafting to highly crosslinked (HXLPE) bearing for THA using a biocompatible-phospholipid-polymer poly (2-methacryloyloxyethyl phosphorylcholine) (PMPC). Such hydrophilic surfaces mimic articular cartilage and are hypothesized to improve lubrication and thereby reduce friction and wear.

We performed in vitro testing of wear and friction of ceramic-on-polyethylene THRs with the PMPC treatment, and compared them with untreated controls. Highly cross-linked UHMWPE bearings, gamma-ray-irradiated at different levels with and without vitamin E (HXL Vit. E: 125 kGy, HXL: 75 kGy, respectively) were divided so half were PMPC treated (n=3 for all four groups). All were paired with identical 40 mm diameter zirconia-toughened-alumina ceramic heads. Testing was carried-out on an AMTI hip simulator for 10 million simulated walking cycles with standard lubricant and conditions (ISO-14242-1). Wear was measured gravimetrically at 21 intervals, and so was frictional torque with a previously described and tested methodology.

PMPC treatment produced a statistically significant 71% in wear reduction of HXL poly (1.70±1.36 mg/Mc for PMPC vs. 5.86±0.402 mg/Mc for controls, p=0.013). A similar significant wear reduction was found for PMPC treated HXL with Vit. E liners (0.736±0.750 mg/Mc, vs. 2.14±0.269 mg/Mc, p=0.035). The improvements were associated with 12% and 5% reductions in friction of the HXL and Vit. E HXL respectively (statistically significant p=0.003, and marginal p=0.116, one tailed).

These results were an important step in the quest for lower wearing, thin and strong UHMWPE liners for larger diameter femoral heads with the potential benefit of longevity and less risk of dislocation after surgery.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 87 - 87
1 Mar 2017
Weisenburger J Kyomoto M Siskey R Kurtz S Garvin K Haider H
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To improve the longevity of total hip replacements (THR), it is necessary to prevent wear of the ultra-high molecular weight polyethylene (UHMWPE) bearing, as wear debris can cause osteolysis and aseptic loosening. Highly cross-linked UHMWPE reduces wear, sometimes stabilized with vitamin E to preserve its mechanical properties and prevent oxidative degeneration. An extra novel solution has been grafting the surface of UHMWPE with poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC). This treatment uses a hydrophilic (wettable) phospholipid polymer to improve lubrication and reduce friction and wear of the bearing material.

We set out to test the wear and friction of ceramic-on-polyethylene (COP) THRs that had the PMPC surface treatment, or left untreated for control. Four groups of UHMWPE bearings were tested against identical 40mm ceramic heads (zirconia-toughened alumina). The UHMWPE bearings were highly cross-linked with/without vitamin E (HXL Vit. E: 125 kGy radiation dose / HXL: 75 kGy). In each group, half underwent the PMPC treatment (n = 3 for all four groups).

Testing was conducted on an AMTI hip simulator for 10 million walking cycles of ISO-14242-1, at 1 Hz, with diluted bovine serum (30 g/L protein concentration) as lubricant, at 37ºC, and with fluid absorption errors corrected with active soak controls. Using a previously published method, frictional torques and a frictional factor around three orthogonal axes about the femoral head were measured/computed, by data processing of the measurements of a 6-DOF load cell on each station of the hip simulator. Such friction measurements and stops for specimen weighing were carried out at regular intervals throughout the wear test.

The HXL liners without and with the PMPC treatment wore at 5.86±0.402 mg/Mc and 1.70±1.36 mg/Mc, respectively (p=0.013) (Fig. 1). The HXL Vit. E liners without and with the PMPC treatment wore at 2.14±0.269 mg/Mc and 0.736±0.750 mg/Mc, respectively (p=0.035). The wear rates of the untreated HXL and HXL Vit. E liners were significantly different (p=0.0002) but no difference in wear rate was found between the two PMPC treated groups (p=0.179), although, as mentioned above, the PMPC treatment very significantly reduced wear in each case. The ceramic femoral heads showed little wear (weight loss) themselves.

In general, the THRs showed decreasing friction over the 10 Mc, with the PMPC types showing a slight increase in friction towards the end of the test (Fig. 2). PMPC HXL liners showed the lowest friction factor (0.022±0.001) which was significantly lower (p<0.001) than the friction of the untreated liners (0.028±0.002) (Fig. 3). The PMPC HXL Vit. E liners showed lower friction factors than the untreated HXL Vit. E liners (0.034±0.002, 0.036±0.004, respectively), although this difference was not significant (p=0.116). Overall, the liners with the PMPC treatment displayed statistically significantly lower friction factors (p=0.003) than those untreated. The coincidence of some reduction of surface friction with larger wear reduction obviously suggests some but not necessarily full causality.

PMPC successfully reduced both the friction and the wear in these COP THRs during this extended 10 Mc test. This likely would translate to improved implant longevity in patients.

For any figures or tables, please contact authors directly (see Info & Metrics tab above).


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 13 - 13
1 Mar 2017
Mihalko W Lowell J Woodard E Arnholt C MacDonald D Kurtz S
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Introduction

Total knee arthroplasty (TKA) is a successful procedure for end stage arthritis of the knee that is being performed on an exponential basis year after year. Most surgeons agree that soft tissue balancing of the TKA is a paramount to provide a successful TKA. We utilized a set of retrieved lower extremities with an existing TKA to measure the laxity of the knee in all three planes to see if wear scores of the implants correlated to the laxity measured. This data has never been reported in the literature.

Methods

IRB approval was obtained for the local retrieval program. Each specimen was retrieved after removing the skin, subcutaneous tissue and muscle from mid thigh to mid tibia. The femur, tibia and fibula were then transversely cut to remove the specimen for testing. Each specimen was then imaged using a flouroscopic imaging unit (OEC, Inc) in the AP, Lateral and sunrise views. These images were used to analyze whether there were any signs of osteolysis. Each specimen was mounted into a custom knee testing machine (Little Rock AR). Each specimen then was tested at full extension, 30, 60, and 90 degrees of flexion. At each flexion angle the specimen was subjected to a 10Nm varus and valgus torque, a 1.5Nm internal and external rotational torque and a 35N anterior and posterior directed force. Each specimen's implants were removed to record manufacturer and lot numbers. Polyethylene damage scores (Hood et al. JBMR 1983) were then calculated in the medial, lateral and backside of the polyethylene insert as well as on the medial and lateral femoral condyle. (Figure 1) Correlation coefficients were then calculated to show any relationship with soft tissue balancing in all three planes and wear scores.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 92 - 92
1 Feb 2017
Day J MacDonald D Kraay M Rimnac C Williams G Abboud J Kurtz S
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Utilization of reverse total shoulder arthroplasty (RTSA) has steadily increased since its 2003 introduction in the American market. Although RTSA was originally indicated for elderly, low demand patients, it is now being increasingly used to treat rotator cuff arthropathy, humeral fractures, neoplasms and failed total and hemi shoulder arthroplasty. There is, therefore, a growing interest in bearing surface wear of RTSA polyethylene humeral liners. In the current study, we examined humeral liners retrieved as part of an IRB approved study to determine the amount of bearing surface wear. We hypothesized that wear of the bearing surface by intentional contact with the glenosphere (mode I) would be minor compared to that produced by scapular notching and impingement of the humeral liner (mode II).

Twenty-three retrieved humeral liners were retrieved at revision surgery after an average of 1.5 years implantation time. The average age at implantation was 68 years (range 50–85). Shoulders were revised for loosening (7), instability (6), infection (6), pain (2), and other/unknown reasons (2). The liners were scanned using microCT at a resolution of 50 µm and then registered against unworn surfaces to estimate the bearing surface wear depth. The depth of surface penetration due to impingement of the liner with surrounding structures was measured and the location of the deepest penetration was noted.

Mode I wear of the bearing surface was detectable for five of the retrieved liners. The penetration depth was 100 µm or less for four of the liners and approximately 250 microns for the fifth liner. It was noted that the liners with discernable mode I wear were those with longer implantation times (average 2.4 years). Material loss and abrasion of the rim due to mode II wear was noted with measurable penetration in 18 of the liners. Mode II wear penetrated to the bearing surface in 11 liners. It was generally noted that volumetric material loss was dominated by mode II wear (Figure 1).

In this study of short to medium term retrieved RTSA humeral liners, mode I wear of the bearing surface was a minor source of material loss. Mode II wear due to scapular notching or impingement of the rim was the dominant source of volumetric wear. This is in agreement with a previous study that we have performed on a smaller cohort of seven liners. It is noteworthy that we were able to detect measurable mode I wear for liners with moderate implantation times. The quantity of bearing surface wear that will be seen in long term retrievals remains unknown at this time.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 19 - 19
1 Feb 2017
Arnholt C MacDonald D Lowell J Gilbert J Mihalko W Kurtz S
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Introduction

Previous studies of CoCr alloy femoral components for total knee arthroplasty (TKA) have identified 3rd body abrasive wear, and apparent inflammatory cell induced corrosion (ICIC) [1] as potential damage mechanisms. The association between observed surface damage on the femoral condyle and metal ion release into the surrounding tissues is currently unclear. The purpose of this study was to investigate the damage on the bearing surface in TKA femoral components recovered at autopsy and compare the damage to the metal ion concentrations in the synovial fluid.

Methods

12 autopsy TKA CoCr femoral components were collected as part of a multi-institutional orthopedic implant retrieval program. The autopsy components included Depuy Synthes Sigma Mobile Bearing (n=1) and PFC (n=1), Stryker Triathlon (n=1) and Scorpio (n=3), and Zimmer Nexgen (n=4) and Natural Knee (n=2). Fluoro scans of all specimens prior to removal was carried out to assure no signs of osteolysis or aseptic loosening were present.

Third-body abrasive wear of CoCr was evaluated using a semi-quantitative scoring method similar to the Hood method [2]. ICIC damage was reported as location of affected area and confirmed using a digital optical microscope with 4000X magnification.

Synovial fluid was aspirated from the joint capsule prior to removal of the TKA device. The synovial fluid was spun at 1600 rpm for 20 minutes in a centrifuge with the cell pellet removed. The supernatant was analyzed in 1 mL quantities for ICP-MS (inductively coupled plasma mass spectrometry) by Huffman Hazen Laboratories. Data was expressed as ppb.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 93 - 93
1 Feb 2017
Kurtz S MacDonald D Kocagoz S Arnholt C Underwood R Rimnac C Gilbert J
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Introduction

There is considerable interest in the orthopaedic community in understanding the multifactorial process of taper fretting corrosion in total hip arthroplasty (THA). Previous studies have identified some patient and device factors associated with taper damage, including length of implantation, stem flexural rigidity, and head offset. Due to the complexity of this phenomenon, we approached the topic by developing a series of matched cohort studies, each attempting to isolate a single implant design variable, while controlling for confounding factors to the extent possible. We also developed a validated method for measuring material loss in retrieved orthopaedic tapers, which contributed to the creation of a new international standard (ASTM F3129-16).

Methods

Based on our implant retrieval collection of over 3,000 THAs, we developed independent matched cohort studies to examine (1) the effect of femoral head material (metal vs. ceramic, n=50 per cohort) and (2) stem taper surface finish (smooth vs. microgrooved, n=60 per cohort). Within each individual study, we adjusted for confounding factors by balancing implantation time, stem taper flexural rigidity, offset, and, when possible, head size. We evaluated fretting and corrosion using a four-point semiquantitative score. We also used an out-of-roundness machine (Talyrond 585) to quantify the material loss from the tapers. This method was validated in a series of experiments of controlled material removal on never-implanted components.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 133 - 133
1 Feb 2017
MacDonald D Caton T Higgs G Malkani A Chen A Mont M Kurtz S
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Background

Sequentially annealed, highly crosslinked polyethylene (HXLPE) has been used clinically in total knee arthroplasty (TKA) for over a decade[1]. However, little is known about the reasons for HXLPE revision, its surface damage mechanisms, or its in vivo oxidative stability relative to conventional polyethylene. We asked whether retrieved sequentially annealed HLXPE tibial inserts exhibited: (1) similar reasons for revision; (2) enhanced resistance to surface damage; and (3) enhanced oxidative stability, when compared with tibial inserts fabricated from conventional gamma inert sterilized polyethylene (control).

Methods

Four hundred and fifty-six revised tibial inserts in two cohorts (sequentially annealed and conventional UHMWPE control) were collected in a multicenter retrieval program between 2000 and 2016. We controlled for implantation time between the two cohorts by excluding tibial inserts with a greater implantation time than the longest term sequentially annealed retrieval (9.5 years). The mean implantation time (± standard deviation) for the sequentially annealed components was 1.9 ± 1.7 years, and for the control inserts, 3.4 ± 2.7 years (Figure 1). Reasons for HXLPE revision were assessed based on medical records, radiographs, and examinations of the retrieved components. Surface damage mechanisms were assessed using the Hood method[2]. Oxidation was measured at the bearing surface, the backside surface, the anterior and posterior faces, as well as the post (when available) using FTIR (ASTM F2102). Surface damage and oxidation analyses were available for 338 of the components. We used nonparametric statistical testing to analyze for differences in oxidation and surface damage when adjusting for polyethylene formulation as a function of implantation time.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 132 - 132
1 Feb 2017
MacDonald D Chen A Lee G Klein G Cates H Mont M Rimnac C Kurtz S
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Introduction

During revision surgery with a well-fixed stem, a titanium sleeve can be used in conjunction with a ceramic head to achieve better stress distribution across the taper surface. Previous studies have observed that the use of a ceramic head can mitigate the extent of corrosion damage at the taper. Moreover, in vitro testing suggests that corrosion is not a concern in sleeved ceramic heads [1]; however, little is known about the in vivo fretting corrosion of the sleeves. The purpose of this study was to investigate fretting corrosion in sleeved ceramic heads.

Materials and Methods

Thirty sleeved ceramic heads (Biolox Option: CeramTec) were collected during revision surgery as part of a multi-center retrieval program. The sleeves were used in conjunction with a zirconia-toughened alumina femoral head. The femoral heads and sleeves were implanted between 0.0 and 3.25 years (0.8±0.9, Figure 1). The implants were revised predominantly for instability (n=14), infection (n=7), and loosening (n=5). Fifty percent of the retrievals were implanted during a primary surgery, while 50% had a history of a prior revision surgery. Fretting corrosion was scored using a previously described 4-point, semi-quantitative scoring system proposed by Higgs [2].


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 94 - 94
1 Feb 2017
Kurtz S Lau E Baykal D Springer B
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Introduction

Previous registry studies of ceramic-on-polyethylene (C-PE) and ceramic-on-ceramic (COC) have focused on revision outcomes following primary surgery. Less is known about the effect of ceramic bearings on infection, dislocation, and mortality as outcomes following primary total hip arthroplasty (THA) for the Medicare population. We asked (1) does the use of C-PE bearings influence outcomes following THA as compared with metal-on-polyethylene (M-PE); and (2) does the use of COC bearings influence outcomes following THA as compared with M-PE?

Methods

A total of 315,784 elderly Medicare patients (65+) who underwent primary THA between 2005 and 2014 with known bearing types were identified from the Medicare 100% inpatient sample administrative database. Outcomes of interest included relative risk of 90-day readmission, infection, dislocation, revision, or mortality at any time point after primary surgery. Propensity scores were developed to adjust for selection bias in the choice of bearing type at index primary surgery. Cox regression incorporating propensity score stratification (10 levels) was then used to evaluate the impact of bearing surface selection on outcomes, after adjusting for patient-, hospital-, and surgeon-related factors.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 11 - 11
1 May 2016
MacDonald D Mehta K Klein G Hartzband M Levine H Mont M Kurtz S
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Introduction

Thermally treated 1st generation highly crosslinked polyethylenes (HXLPE) have demonstrated reduced penetration and osteolysis rates, however, concerns still remain with respect to oxidative stability and mechanical properties of these materials. To address these concerns, manufacturers have introduced the use of antioxidants to quench free radicals while maintaining the mechanical properties of the HXLPE. Two common antioxidants are α-tocopherol (Vitamin-E) and pentaerythritol tetrakis (PBHP). These may be either mixed prior to consolidation, or diffused throughout the polymer after consolidation and irradiation. In vitrostudies have shown that these materials are oxidatively stable and have improved mechanical properties compared to 1st generation HXLPEs; however, few studies have investigated the in vivo performance of anti-oxidant stabilized HXLPE. The purpose of this study was to investigate the revision reasons, oxidation, and mechanical properties of retrieved short-term anti-oxidant HXLPE.

Methods

Between 2010 and 2015, 73 anti-oxidant HXLPE components were collected as a part of an IRB approved, multi-institutional retrieval analysis program during routine revision surgery. Of the seventy-three components, 30 (41%) were acetabular liners, whereas, 43 were tibial inserts. The components were fabricated from three different materials: Vitamin-E Diffused HXLPE (n=30; E1, Biomet), Vitamin-E Blended (n = 41; Vivacit-E, Zimmer) and PBHP blended (n = 2, AOX, DePuy). The hip and knee components were implanted for 0.7 ± 0.8 years (Range: 0.0–2.25 years) and 0.8 ± 1.1 years (Range: 0.0–4.5 years), respectively. Implantation time, patient weight, age, gender, and activity levels were similar between hip and knee components (Table 1).

For oxidation analysis, thin slices (∼200μm) were taken from medial condyle and central eminence of the tibial inserts or the superior/inferior axis from hip components. The slices were boiled in heptane for six hours to extract lipids absorbed in vivo. 3-millimeter FTIR line scans were taken perpendicular to the surface of interest, according to the ASTM F2102. Mechanical properties were assessed using the small punch test (ASTM F2183). Forty-three explants were available for destructive testing.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 26 - 26
1 May 2016
Hanzlik J Day J Kurtz S Verdonschot N Janssen D
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Introduction

Initial large-scale clinical studies of porous tantalum implants have been generally promising with well-fixed implants and few cases of loosening [1–3]. An initial retrieval study suggests increased bone ingrowth in a modular tibial tray design compared to the monoblock design [4]. Since micromotion at the bone-implant interface is known to influence bone ingrowth [5], the goal of this study was to determine the effect of implant design, bone quality and activity type on micromotion at the bone-implant interface, through FE modeling.

Patients & Methods

Our case-specific FE model of bone was created from CT data (68 year-old female, right tibia, Fig-1). Isotropic properties of cortical and trabecular bone were derived from the calibrated CT data. Modular and monoblock porous tantalum tibial implants were virtually placed in the tibia following surgical guidelines. All models parts were 3D meshed with 4-noded tetrahedral elements (MSC.MARC-Mentat 2013, MSC Software Corporation, USA). Frictional contact was applied to the bone-tantalum interface (µ=0.88) and UHWMPE-Femoral condyle interface (µ=0.05) with all other interfaces bonded. Loading was applied to simulate walking, standing up and descending stairs. For each activity, a full load cycle [6] was applied to the femoral condyles in incremental steps. The direction and magnitude of micromotions were calculated by tracking the motions of nodes of the bone, projected onto the tibial tray. Micromotions were calculated parallel to the implant surface (shear), and perpendicularly (tensile). We report the maximum (resultant) micromotion that occurred during a cycle of each activity. The bone properties were varied to represent a range in BMD (−30%BMD, Norm, +30%BMD). We compared design type, bone quality and activity type considering micromotion below 40 µm to be favorable for bone ingrowth [5].


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 23 - 23
1 May 2016
Arnholt C MacDonald D Kocagoz S Chen A Cates H Klein G Rimnac C Kurtz S
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Introduction

Previous studies of long-term CoCr alloy femoral components for TKA have identified 3rd body abrasive wear and inflammatory cell induced corrosion (ICIC). The extent of femoral condyle surface damage in contemporary CoCr femoral components is currently unclear. The purpose of this study was to investigate the prevalence and morphology of damage (3rd body scratches and ICIC) at the bearing surface in retrieved TKA femoral components from contemporary designs.

Methods

308 CoCr femoral TKA components were collected as part of an ongoing, multi-institutional orthopedic implant retrieval program. The collection included contemporary designs from Stryker (Triathlon n=48, NRG n=10, Scorpio n=31), Depuy Synthes (PFC n=27) and Zimmer (NexGen n=140, Persona n=1) and Biomet (Vanguard n=51). Hinged knee designs and unicondylar knee designs were excluded. Components were split into groups based on implantation time: short-term (1–3y, n=134), intermediate-term (3–5y, n=73) and long-term (6–15y, n=101). Each grouping was mainly revised for instability, infection and loosening.

Third-body abrasive wear of CoCr was evaluated using a semi-quantitative scoring method similar to the Hood method (Figure 1). A score of 1 had minimal damage and a score of 4 corresponded to damage covering more than 50% of the evaluated area. ICIC damage was reported as location of affected area. A white light interferometer (Zygo New View 5000) was also used to analyze the topography of severe damage of the bearing surface. For this analysis, three representative components from each cohort were selected and analyzed in three locations on the apex of the bearing surface. We analyzed the following roughness parameters: Ra, Rsk, and Rku.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 10 - 10
1 May 2016
MacDonald D Schachtner J Chen A Cates H Klein G Mont M Kraay M Malkani A Lee G Hamlin B Rimnac C Kurtz S
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Introduction

Highly crosslinked polyethylene (HXLPE) was clinically introduced approximately a decade and a half ago to reduce polyethylene wear rates and subsequent osteolysis. Clinical and radiographic studies have repeatedly shown increased wear resistance, however concerns of rim oxidation and fatigue fracture remain. Although short to intermediate term retrieval studies of these materials are available, the long-term behavior of these materials remains unclear.

Methods

Between 2000 and 2015, 115 1st generation HXLPE acetabular liners implanted for 5 or more years were collected and analyzed as part of an ongoing, multi-institutional orthopaedic implant retrieval program. There were two material cohorts based on thermal processing (annealed (n=45) and remelted (n=70)). Each cohort was stratified into two more cohorts based on implantation time (5 – 10 years and >10 years). For annealed components, the intermediate-term liners (n=30) were implanted on average (±SD) for 7.3 ± 1.7 years while the long-term liners (n=15) were implanted for 11.3 ± 1.8 years. For remelted components, the intermediate-term liners (n=59) were implanted on average (±SD) for 7.2 ± 1.3 years while the long-term liners (n=11) were implanted for 11.3 ± 1.2 years. For each cohort, the predominant revision reasons were loosening, instability, and infection (Figure 1). Short-term liners (in-vivo <5ys) from previous studies were analyzed using the same protocol for use as a reference.

For oxidation analysis, thin slices (∼200 μm) were taken from the superior/inferior axis and subsequently boiled in heptane for 6 hours to remove absorbed lipids that may interfere with the oxidation analysis. 3mm line profiles (in 100μm increments) were taken perpendicular to the surface at each region of interest. Oxidation indices were calculated according to ASTM 2102. Penetration was measured directly using a calibrated micrometer (accuracy=0.001mm).


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 128 - 128
1 May 2016
Kurtz S Lau E Baykal D Springer B
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Introduction

Previous studies of ceramic-on-polyethylene (C-PE) and ceramic-on-ceramic (COC) hip bearings have focused on outcomes following primary surgery. Less is known about the utilization or outcomes of ceramic bearings in revision total hip arthroplasty (R-THA) for the Medicare population in the US. We asked (1) what is the utilization of ceramic bearings for R-THA in the Medicare population and how has it evolved over time; (2) does the use of C-PE bearings influence outcomes following R-THA as compared with metal-on-polyethylene (M-PE); and (3) does the use of COC bearings influence outcomes following R-THA as compared with M-PE?

Methods

A total of 31,809 Medicare patients (aged > 65y) who underwent R-THA between 2005 and 2013 with known bearing types were identified from the Medicare 100% inpatient sample administrative database. Outcomes of interest included relative risk of readmission (90 days) or infection, dislocation, rerevision, or mortality at any time point after revision. Propensity scores were developed to adjust for selection bias in the choice of bearing type at revision surgery. Cox regression incorporating propensity score stratification (10 levels) was then used to evaluate the impact of bearing surface selection on outcomes, after adjusting for patient-, hospital-, and surgeon-related factors.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 129 - 129
1 May 2016
Kurtz S Arnholt C MacDonald D Higgs G Underwood R Chen A Klein G Hamlin B Lee G Mont M Cates H Malkani A Kraay M Rimnac C
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Introduction

Previous studies of retrieved CoCr alloy femoral heads have identified imprinting of the stem taper surface features onto the interior head bore, leading researchers to hypothesize that stem taper microgrooves may influence taper corrosion. However, little is known about the role of stem taper surface morphology on the magnitude of in vivo corrosion damage. We designed a matched cohort retrieval study to examine this issue.

Methods

From a multi-institutional retrieval collection of over 3,000 THAs, 120 femoral head-stem pairs were analyzed for evidence of fretting and corrosion using a visual scoring technique based on the severity and extent of fretting and corrosion damage observed at the taper. A matched cohort design was used in which 60 CoCr head-stem pairs with a smooth stem taper were matched with 60 CoCr head-stem pairs having a micro-grooved surface, based on implantation time, flexural rigidity, apparent length of taper engagement, and head size. This study was adequately powered to detect a difference of 0.5 in corrosion scores between the two cohorts, with a power of 82% and 95% confidence. Both cohorts included CoCr and Ti-6-4 alloy femoral stems. A high precision roundness machine (Talyrond 585, Taylor Hobson, UK) was used to measure surface morphology and categorize the stem tapers into smooth vs. micro-grooved categories. Fretting and corrosion damage at the head/neck junction was characterized using a modified semi-quantitative adapted from the Goldberg method by three independent observers. This method separated corrosion damage into four visually determined categories: minimal, mild, moderate and severe damage.