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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 69 - 69
1 Feb 2017
Kim J Cho H
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Purpose. We evaluated the clinical and radiographic outcomes of cementless bipolar hemiarthroplasty using rectangular cross-section stem for femoral neck fracture in elderly patients more than 80 years of age with osteoporosis. Material and Methods. 76(cemented 46, cementless 30) bipolar hemiarthroplasties for femur neck fracture were performed in elderly patients more than 80 years old. The mean follow-up period was 4.3 years (2 to 7 years). The Harris hip score at last follow-up and pre-postoperative daily living activity scale according to Kitamura methods were analyzed clinically. The radiological results were assessed using stability of femoral stem and other complications were evaluated. Results: At last follow-up, there were no significant differences of Harris hip score and daily living activity between two groups. Stem loosening and instability were not observed in cementless arthroplasty. There were 18 cases of osseous fixation in radiologic study. There were 1 case of dislocation and 1 case of superficial infection in cemented arthroplasty and 1 case of deep infection in cementless arthroplasty. Conclusion. Cementless bipolar hemiarthroplasty using rectangular cross-section stem for elderly patients with a femoral neck fracture showed satisfactory short-term clinical and radiological results compared to using cement stem


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 125 - 125
1 Mar 2017
Zhou C Sethi K Willing R
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Transforaminal lumbar interbody fusion (TLIF) using an implanted cage is the gold standard surgical treatment for disc diseases such as disc collapse and spinal cord compression, when more conservative medical therapy fails. Titanium (Ti) alloys are widely used implant materials due to their superior biocompatibility and corrosion resistance. A new Ti-6Al-4V TLIF cage concept featuring an I-beam cross-section was recently proposed, with the intent to allow bone graft to be introduced secondary to cage implantation. In designing this cage, we desire a clear pathway for bone graft to be injected into the implant, and perfused into the surrounding intervertebral space as much as possible. Therefore, we have employed shape optimization to maximize this pathway, subject to maintaining stresses below the thresholds for fatigue or yielding. The TLIF I-beam cage (Fig. 1(a)) with an irregular shape was parametrically designed considering a lumbar lordotic angle of 10°, and an insertion angle of 45° through the left or right Kambin's triangles with respect to the sagittal plane. The overall cage dimensions of 30 mm in length, 11 mm in width and 13 mm in height were chosen based on the dimensions of other commercially available cages. The lengths (la, lp) and widths (wa, wp) of the anterior and posterior beams determine the sizes of the cage's middle and posterior windows for bone graft injection and perfusion, so they were considered as the design variables for shape optimization. Five dynamic tests (extension/flexion bending, lateral bending, torsion, compression and shear compression, as shown in Fig. 2(b)) for assessing long term cage durability (10. 7. cycles), as described in ASTM F2077, were simulated in ANSYS 15.0. The multiaxial stress state in the cage was converted to an equivalent uniaxial stress state using the Manson-Mcknight approach, in order to test the cage based on uniaxial fatigue testing data of Ti-6Al-4V. A fatigue factor (K) and a critical stress (σcr) was introduced by slightly modifying Goodman's equation and von Mises yield criterion, such that a cage design within the safety design region on a Haigh diagram (Fig. 2) must satisfy K ≤ 1 and σcr ≤ SY = 875 MPa (Ti-6Al-4V yield strength) simultaneously. After shape optimization, a final design with la = 2.30 mm, lp = 4.33 mm, wa = 1.20 mm, wp = 2.50 mm, was converged upon, which maximized the sizes of the cage's windows, as well as satisfying the fatigue and yield strength requirements. In terms of the strength of the optimal cage design, the fatigue factor (K) under dynamic torsion approaches 1 and the critical stress (σcr) under dynamic lateral bending approaches the yield strength (SY = 875 MPa), indicating that these two loading scenarios are the most dangerous (Table 1). Future work should further validate whether or not the resulting cage design has reached the true global optimum in the feasible design space. Experimental validation of the candidate TLIF I-beam cage design will be a future focus. For any figures or tables, please contact authors directly (see Info & Metrics tab above).


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 34 - 34
1 Feb 2020
Slater N Justin D Su E Pearle A Schumacher B
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Traditional procedures for orthopedic total joint replacements have relied upon bone cement to achieve long-term implant fixation. This remains the gold standard in number of procedures including TKR and PKR. In many cases however, implants fixed with cement have proven susceptible to aseptic loosening and 3. rd. body wear concerns. These issues have led to a shift away from cement fixation and towards devices that rely on the natural osteoconductive properties of bone and the ability of porous-coated implants to initiate on-growth and in-growth at the bone interface, leading to more reliable fixation. To facilitate long-term fixation through osseointegration, several mechanical means have been utilized as supplemental mechanism to aid in stabilizing the prostheses. These methods have included integrated keels and bone screws. The intent of these components is to limit implant movement and provide a stable environment for bone ingrowth to occur. Both methods have demonstrated limitations on safety and performance including bone fracture due keel induced stresses, loosening due to inconsistent pressfit of the keel, screw-thread stripping in cancellous bone, head-stripping, screw fracture, screw loosening, and screw pullout. An alternative method of fixation utilizing blade-based anchoring has been developed to overcome these limitations. The bladed-based fixation concept consists of a titanium alloy anchor with a “T-shaped” cross-section and sharped-leading end that can be impacted directly into bone. The profile is configured to have a bladed region on the horizontal crossbar of the “T” for engagement into bone and a solid rail at the other end to mates with a conforming slot on the primary body of the prosthesis. A biased chisel tip is added to the surface of the leading blade edge to draw the bone between the anchor's horizontal surface and surface of the implant, thus generating a compressive force at the bone-to-prothesis interface. The anchoring mechanism has been successfully been integrated into the tibial tray component of a partial knee replacement; an implant component that has a clinical history of revision due to loosening. A detailed investigation into the pulloff strength, wear debris generation, compressive-force properties, and susceptibility to tibial bone fracture was carried out on the anchor technology when integrated in a standard tibial tray of a partial knee replacement. When tested in rigid polyurethane bone foam (Sawbones, Grade 15) the pulloff strength of the construct increased by 360% when utilizing the anchor. The tibial tray and anchor construct were cycled under compressive loading and demonstrated no evidence of interface corrosion or wear debris generation after 1 million cycles. In addition, the anchor mechanism was shown to generate 340N of compressive force at the tibial tray-to-bone interface when evaluated with pressure sensitive film (Fuji Prescale, Medium Grade). Finally, the ultimate compressive load to induce tibial fracture was shown to increase by 17% for the anchored tray as compared to a traditional keeled tray when tested in an anatomic tibial sawbones model; and by 19% when evaluated in human cadaveric tibias. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 22 - 22
1 Feb 2020
Lawrence J Keggi J Randall A DeClaire J Ponder C Koenig J Shalhoub S Wakelin E Plaskos C
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Introduction. Soft-tissue balancing methods in TKA have evolved from surgeon feel to digital load-sensing tools. Such techniques allow surgeons to assess the soft-tissue envelope after bone cuts, however, these approaches are ‘after-the-fact’ and require soft-tissue release or bony re-cuts to achieve final balance. Recently, a robotic ligament tensioning device has been deployed which characterizes the soft tissue envelope through a continuous range-of-motion after just the initial tibial cut, allowing for virtual femoral resection planning to achieve a targeted gap profile throughout the range of flexion (figure-1). This study reports the first early clinical results and patient reported outcomes (PROMs) associated with this new technique and compares the outcomes with registry data. Methods. Since November 2017, 314 patients were prospectively enrolled and underwent robotic-assisted TKA using this surgical technique (mean age: 66.2 ±8.1; females: 173; BMI: 31.4±5.3). KOOS/WOMAC, UCLA, and HSS-Patient Satisfaction scores were collected pre- and post-operatively. Three, six, and twelve-month assessments were completed by 202, 141, and 63 patients, respectively, and compared to registry data from the Shared Ortech Aggregated Repository (SOAR). SOAR is a TJA PROM repository run by Ortech, an independent clinical data collection entity, and it includes data from thousands of TKAs from a diverse cross-section of participating hospitals, teaching institutions and clinics across the United States and Canada who collect outcomes data. PROMs were compared using a two-tailed t-test for non-equal variance. Results. When comparing the baseline PROM scores, robotic patients had equivalent womac knee stiffness (p=0.58) and UCLA activity scale (p=0.38) scores but slightly higher womac knee pain (p=0.002) and functional scores (p=0.014, figure-2). While all scores improved over time, the rate of improvement was generally greater at 6 months than at three months when comparing the two groups, with statistically higher six-month scores in the robotic group for all categories (p<0.001). Overall patient satisfaction in the RB cohort was 90.3%, 95.0% and 91.8% at 3M, 6M and 1Y, respectively (figure-3). Average length of hospital stay was 1.6 days (±0.8). Surgical complications in this cohort included one infection four months post-op, 6 post-operative knee manipulations, one pulmonary embolism and one wound dehiscence from a fall. Discussion. We postulated that the ability to use gap data prospectively under known loading conditions throughout the knee range-of-motion would allow femoral cut planning that resulted in optimum balance with fewer releases and better long-term results. While the study group patients had slightly higher baseline knee pain and function than registry patients and showed similar net improvements at the three-month mark, study patients showed significantly better improvements in all areas between three months and six months compared to registry data. WOMAC stiffness and UCLA activity scores were equal between the two groups at baseline and significantly improved at three months and six months. Better ligament balance may have significantly contributed to these gains and to the high rates of satisfaction reported in the study patients compared to the historical literature. Limitations to this study include the small number of patients and the lack of a closely matched control group. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 115 - 115
1 Apr 2019
Bock R Cullen D McEntire B More K Leonard D Bal BS
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Introduction. The osteogenic capability of any biomaterial is governed by a number of critical surface properties such as surface energy, surface potential, and topography. Prior work suggested that the Si-Y-O-N phase(s) present in the form of a thin (<150 nm), interrupted film at the surface of an annealed silicon nitride bioceramic may be responsible for an observed upregulation of osteoblastic activity due to passive surface properties and dissolution of chemical species. In this study high- resolution analytical electron microscopy was utilized to identify the Si-Y-O-N phase present on the annealed silicon nitride surface, and dissolution studies were employed to elucidate mechanisms of the material's favorable cell interactions. Materials and Methods. Si. 3. N. 4. discs (12.7 mm diameter × 1 mm thick) containing Y. 2. O. 3. and Al. 2. O. 3. sintering aids were processed using conventional techniques and subsequently subjected to annealing in a nitrogen atmosphere. Pre-cultured SaOS-2 osteosarcoma cells at a concentration of 5 × 10. 5. cells/ml were seeded onto sterile polished nitrogen-annealed Si. 3. N. 4. discs in an osteogenic medium consisting of DMEM supplemented with about 50 µg/mL ascorbic acid, 10 mM β-glycerol phosphate, 100 mM hydrocortisone, and 10% fetal bovine calf serum. The samples were incubated for up to 7 days at 37°C with two medium replenishments. Transmission electron microscopy (TEM) images were acquired from focused ion beam (FIB)-prepared samples using a Hitachi HF-3300 TEM (300 kV). Scanning transmission electron microscopy (STEM) images were recorded using a Nion UltraSTEM 100 (60 kV). STEM high-angle annular dark-field (HAADF) imaging and energy dispersive X-ray spectroscopy (EDS) analyses were performed on a JEOL JEM2200FS (200 kV) equipped with a third-order CEOS aberration corrector and a Bruker XFlash silicon drift detector. Results. A cross-section of the of the Si. 3. N. 4. /extracellular polymer (ECP) interface is illustrated in Fig. 1(a)∼(b) as a high- angle annular dark field (HAADF) STEM image (a) with and EDS map overlay (b) highlighting locations of Ca, Y, and Si. The underlying Si. 3. N. 4. microstructure is covered by a yttrium-rich intergranular phase (IGP) film. Deposition of cell-derived hydroxyapatite (HAp) occurred directly onto this IGP film. In Fig. 2, a bright field TEM image (electron diffraction pattern inset) shows the interface between the partially-crystalline HAp and the Y-Si-O-N phase, identified as monoclinic yttrium disilicate (i.e., m-Y. 2. Si. 2. O. 7. ) with a 2 atomic% N impurity, at teh atomic scale. Although rapid electron damage of the mineralized ECP was observed, EDS analyses suggested a Ca/P ratio of ∼1.43, along with the incorporation of Si. Conclusions. The osteogenic Si-Y-O-N phase was successfully identified as a minority concentration of Si. 3. N. 4. dissolved into a m-Y. 2. Si. 2. O. 7. matrix. Evidence of the release of (SiO. 4. ). 4−. tetrahedra from this phase into the local biological microenvironment and their incorporation into the cell-derived HAp layer was also observed. Identification of this phase paves the way for ongoing work to understand and optimize this novel biomaterial. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 17 - 17
1 Apr 2018
Lee J
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Purpose. The purpose of this study is to report the results of the first 1000 cases hip arthroplasty using the Bencox. ®. hip stem, the first hip prosthesis developed and manufactured in Korea. Material & Method. This study reviewed 1000 cases retrospectively who underwent arthroplasty using Bencox. ®. hip system. The Bencox. ®. hip stem is the first hip prosthesis developed and manufactured in Korea. This stem have a double-tapered, wedge shape figure with a rectangular-shaped cross-section and specially designed neck shape, which is design to achieve normal stress pattern of the proximal femur and to increase initial stability and to increase range of motion. Surface is treated with MAO (Micro Arc Oxidation) coating. From the first arthroplasty with this system in September 2006, sequentially 1000 arthroplasties were performed by single surgeon until the July 2014. This material included 439 men and 561 female. Average age of patients was 65 year old. Follow up period was average 72.1 month (minimum 34 months to maximum 120 months). 1000 cases consisted of 569 hips in patients with femoral neck or intertrochanteric fracture or subtrochanteric fracture (fracture group), 155 hips in osteoarthritis, 192 hips in patients with osteonecrosis of the femoral head (arthritis group), 84 hips in revision surgery (revision group). Revision cases consisted of 58 hips with aseptic loosening and 26 hips with loosening due to infection sequelae. They were underwent hip arthroplasty using a Bencox. ®. hip stem in combination with Bencox. ®. bipolar cup and Bencox. ®. acetabular cup. Patients in the fracture group usually underwent bipolar hip arthroplasty, and those in the arthritis group and revision group underwent total hip arthroplasty. They were reviewed by medical records, clinically and radiologically. Results. During the follow-up period, there were no cases of revision of the femoral stem. Radiographically, there were no cases of radiolucent line except very proximal part of the stem endosteal bone ongrowth was found in most cases. Postoperative complications such as stem loosening, infection, dislocation, and ceramic breakage were not noted. But periprosthetic fracture was encountered in 7 hips due to slip down. They were treated by open reduction and internal fixation with plate and cables. There were no cases of failure of these treatments. Conclusion. Clinical and radiographic evaluations of hip arthroplasty using the Bencox. ®. hip system showed excellent outcomes with average 72.1 month follow-up in 1000 case


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 18 - 18
1 Apr 2018
Preutenborbeck M Holub O Anderson J Jones A Hall R Williams S
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Introduction. Up to 60% of total hip arthroplasties (THA) in Asian populations arise from avascular necrosis (AVN), a bone disease that can lead to femoral head collapse. Current diagnostic methods to classify AVN have poor reproducibility and are not reliable in assessing the fracture risk. Femoral heads with an immediate fracture risk should be treated with a THA, conservative treatments are only successful in some cases and cause unnecessary patient suffering if used inappropriately. There is potential to improve the assessment of the fracture risk by using a combination of density-calibrated computed tomographic (QCT) imaging and engineering beam theory. The aim of this study was to validate the novel fracture prediction method against in-vitro compression tests on a series of six human femur specimens. Methods. Six femoral heads from six subjects were tested, a subset (n=3) included a hole drilled into the subchondral area of the femoral head via the femoral neck (University of Leeds, ethical approval MEEC13-002). The simulated lesions provided a method to validate the fracture prediction model with respect of AVN. The femoral heads were then modelled by a beam loaded with a single joint contact load. Material properties were assigned to the beam model from QCT-scans by using a density-modulus relationship. The maximum joint loading at which each bone cross-section was likely to fracture was calculated using a strain based failure criterion. Based on the predicted fracture loads, all six femoral heads (validation set) were classified into two groups, high fracture risk and low fracture risk (Figure 1). Beam theory did not allow for an accurate fracture load to be found because of the geometry of the femoral head. Therefore the predicted fracture loads of each of the six femoral heads was compared to the mean fracture load from twelve previously analysed human femoral heads (reference set) without lesions. The six cemented femurs were compression tested until failure. The subjects with a higher fracture risk were identified using both the experimental and beam tool outputs. Results. The computational tool correctly identified all femoral head samples which fractured at a significantly low load in-vitro (Figure 2). Both samples with a low experimental fracture load had an induced lesion in the subchondral area (Figure 3). Discussion. This study confirmed findings of a previous verification study on a disease models made from porcine femoral heads (Preutenborbeck et al. I-CORS2016). It demonstrated that fracture prediction based on beam theory is a viable tool to predict fracture. The tests confirmed that samples with a lesion in the weight bearing area were more likely to fracture at a low load however not all samples with a lesion fractured with a low load experimentally, indicating that a lesion alone is not a sufficient factor to predict fracture. The developed tool takes both structural and material properties into account when predicting the fracture risk. Therefore it might be superior to current diagnostic methods in this respect and it has the added advantage of being largely automated and therefore removing the majority of user bias. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_15 | Pages 52 - 52
1 Aug 2017
Sculco P
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Stiffness after total knee arthroplasty (TKA) is a common problem occurring between 5% and 30% of patients. Stiffness is defined as limited range of motion (ROM) that affects activities of daily living. A recent International Consensus on definition of stiffness of the knee graded stiffness as mild, moderate or severe (90–100, 70–89, <70, respectively) or an extension deficit (5–10, 11–20, >20). Stiffness can be secondary to an osseous, soft tissue, or prosthetic block to motion. Heterotopic bone or retained posterior osteophytes, abundant fibrotic tissue, oversized components with tight flexion or extension gaps or component malrotation can all limit knee motion. Infection should always be considered in the knee that gradually loses motion. Alternative causes include complex regional pain syndrome and Kinesiophobia that can limit motion without an underlying mechanical cause. The evaluation of knee stiffness radiographs of the knee and cross-section imaging should be performed if component malrotation is considered. A metal suppression MRI assists in quantifying the extent of fibrosis and its location in the anterior or posterior compartment of the knee. Inflammatory markers and joint aspiration as indicated to rule out infection. Arthrofibrosis, or post-surgical fibrosis, is related to abnormal scar formation after surgery that leads to loss of motion. The cause of arthrofibrosis is multifactorial and likely related to genetic host factors. Current research is focusing on molecular signatures that may better identify patients at risk. In addition, therapeutic interventions are being studied that best prevent fibrosis and its recurrence and include the use of anti-inflammatories, corticosteroids, Colchicine, biologic medications (IL-1 inhibitors) and low-dose radiation. Early treatment of the stiff TKA includes physical therapy and manipulation under anesthesia (MUA). MUA performed within 3 months may have the greatest increase in ROM but notable improvement can occur up to 6 months after TKA. After six months, arthroscopic or open surgery is recommended for persistent stiffness. Arthroscopic lysis of adhesions can improve ROM greater than 1 year after index TKA. Average improvement of ROM for both MUA and arthroscopic lysis of adhesions (usually in conjunction with MUA) is approximately 30 degrees. The outcome after open lysis of adhesions are reportedly poor but current adjuvant therapies may improve these clinical outcomes as this addresses the biologic, in addition to the mechanical, basis of fibrosis. Component revision performed for component malposition and stiffness has variable outcomes but a recent study reports a mean increase in ROM of 20 degrees and a modest improvement in overall knee function. The cause of post-operative stiffness after TKA is a complex interplay of the patient, surgeon, and post-operative factors. Correct diagnosis of the underlying cause of the stiff total knee is essential to optimizing treatment outcomes. More research in needed in how to best prevent and treat the biologic risk factors and pathways that contribute to post-surgical fibrosis


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 10 - 10
1 Apr 2017
Su E
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In recent years, cementless stems have dominated the North American market. There are several categories of cementless stems, but in the past 20 years, the two most popular designs in the United States have been the extensively coated cylindrical cobalt-chrome (CoCr) stem and the proximally coated tapered titanium stem, which in recent years has become the most common. The 10-year survival for both stem types has been over 95% with a distinction made on factors other than stem survival, including thigh pain, stress shielding, complications of insertion, and ease of revision. Conventional wisdom holds that proximally coated titanium stems have less stress shielding, less thigh pain, and a higher quality clinical result. Recent studies, however, including randomised clinical trials have found that the incidence of thigh pain and clinical result is essentially equivalent between the stem types, however, there is a modest advantage in terms of stress shielding for a tapered titanium stem over an extensively coated CoCr stem. One study utilizing pain drawings did establish that if a CoCr cylindrical stem was utilised, superior clinical results in terms of pain score and pain drawings were obtained with a fully coated versus a proximally coated stem. In spite of the lack of a clinically proven advantage in randomised trials, tapered titanium stems have been favored because of the occasional occurrence of substantial stress shielding, the increased clinical observation of thigh pain severe enough to warrant surgical intervention, ease of use of shorter tapered stems that involve removal of less trochanteric bone and less risk of fracture both at the trochanter and the diaphysis due to the shorter, and greater ease of insertion through more limited approaches, especially anterior approaches. When tapered stems are utilised, there may be an advantage to a more rectangular stem cross-section in patients with type C bone. In spite of the numerous clinical advantages of tapered titanium stems, there still remains a role for more extensively coated cylindrical stems in patients that have had prior surgery of the proximal femur, particularly for a hip fracture, which makes proximal fixation, ingrowth, and immediate mechanical stability difficult to assure consistently. Cement fixation should also be considered in these cases. While the marketplace and the clinical evidence strongly support routine use of tapered titanium proximally coated relatively short stems with angled rather than straight proximal lateral geometry in the vast majority of cases, there still remains a role for more extensively coated cylindrical and for specific indications


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. Results. The oxidation profiles of each sample at 0.0mm (Fig 2a) and 3.0mm (Fig 2b) from the center point of load application showed that as one decreases the thickness of the test sample the oxidation levels of the sample increase. Both locations showed increased oxidation over the control samples. Discussion. Cyclic loading increased the rate of oxidation of gamma sterilized UHMWPE. The oxidation also increased with decreasing thickness of the UHMWPE samples. This oxidation could potentially accelerate the long term oxidative instability and could contribute to the delamination failure of tibial inserts. For figures/tables, please contact authors directly.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 14 - 14
1 Feb 2017
Higa M Manabe T Nakamura Y Tanino H
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Introduction. Although total hip arthroplasty (THA) has been one of the most successful, reliable and common prosthetic techniques since the introduction of cemented low-friction arthroplasty by Charnley in the early 1960s, aseptic loosening due to stem-cement and cement-bone interface failures as well as cement fractures have been known to occur. To overcome this loosening, the stem should be mechanically retentive and stable for long term repetitive loading. Migration studies have shown that all stems migrate within their cement mantle, sometimes leading to the stem being debonded from the cement [1]. If we adopt the hypothesis that the stems debond from the cement mantle, the stem surface should be polished. For the polished stem, the concept of a double taper design, which is tapered in the anteroposterior (AP) and mediolateral (ML) planes, and a triple-tapered design, which has trapezoidal cross-section with the double tapered, have been popularized. Both concepts performed equally well clinically [2]. In this study, we aimed to analyze stress patterns for both models in detail using the finite element (FE) method. Methods. An ideal cemented stem with bone was made using three dimensional FE analyses (ANSYS 13). The cortical bone was 105 mm long and 7 mm thick and the PMMA cement mantle was 5 mm in thickness surrounding the stem. Young's modulus was set at 200 GPa for the bone and 2.2 GPa for the cement. Poisson's ratio was 0.3 for both materials. The bone-cement interface was completely bonded and cement-stem interface was not bonded in cases where a polished stem surface was used. The two types of stems were compared. One being the double tapered (Fig 1 left) and the other the triple tapered (Fig 1 right). The coefficient of friction (μ) at the stem-cement interface was set at 0 for both models. The distal ends of the stems were not capsulated by the PMMA and therefore the stems were free to subside. All materials were assumed to be linearly isotropic and homogeneous. The distal ends of the bone were completely constrained against any movements and rotations. An axial load of 1200 N and a transverse load of 600 N were applied at the same time simulating the bending condition [3]. Results. Although the stress distribution differences between the designs were minor, the positions where higher stresses and absolute values in the cement were observed varied. For double tapered model, the highest maximum principal stress was 1.98 MPa observed around the corner of the stem at the proximal region. For the triple tapered model, the highest maximum principal stress was 1.67 MPa observed at more medial side than the double tapered model


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 75 - 75
1 Nov 2016
Meneghini R
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Cementless femoral components have an excellent track record that includes efficient implantation and long-term survival, thus are the predominant stem utilised in North America. Femoral component stability and resistance to subsidence are critical for osseointegration and clinical success. Implant design, surgical technique, anatomic fit, and patient characteristics, such as bone quality, can all effect initial implant stability and resistance to subsidence. Variability in stem shape and in the anatomy of the proximal femoral metaphysis has been implicated in the failure of some stem designs. Biologic fixation obtained with osseointegration of cementless implants may improve implant longevity in young, active, and obese patients. Lack of intimate fit can lead to clinical complications such as subsidence, aseptic loosening, and peri-prosthetic fracture. Currently, there are several stem designs, all of which aim to achieve maximal femoral stability and minimal subsidence and include: Fit and Fill / Double Taper Proximally Porous Coated Stems; Parallel Sided Taper Wedge or “Blade” Stems; Wagner Style Conical Shape Splined Titanium Stems; Tapered Rectangular Cross-Section Zweymuller Stem; Fully-Porous Coated Stems; Modular Proximal Sleeve Fluted Stem; Anatomic Proximally Porous Coated Stems. The majority of patients with relatively straightforward anatomy can be treated with any of the aforementioned femoral implant types. However, more complicated femoral anatomy frequently requires a particular implant type to maximise stability and promote osseointegration. Stems with femoral deformity in the meta-diaphyseal region may require a shorter stem in order to avoid an osteotomy. Distorted femoral anatomy typically seen in childhood diseases, such as dysplasia, may require a modular proximal sleeve tapered fluted stem or Wagner style cone stem to impart optimal stem anteversion separate from the native femoral neck version. The most severe forms of dysplasia may require a shortening osteotomy and subsequent distal fixation and neck version flexibility, which can be addressed with a modular proximal sleeve fluted or fully porous coated stem. A stovepipe or osteoporotic femur may require a stem that engages more distally such as a conical splined tapered stem, a fully porous coated stem or even a cemented stem to achieve adequate stability. Finally, obese patients are a particular challenge and emerging data suggests that a morphologically based parallel-sided taper wedge stems may confer greater stability and resistance to subsidence in these patients. Ultimately, an appropriate selection algorithm will facilitate an appropriate match of the patient morphology with femoral implant geometry that facilitates stable fixation and osseointegration


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 128 - 128
1 Jan 2016
Fetto J
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Recent introduction of short femoral implants has produced inconsistent outcomes. There have been reports of early aseptic failure as high as 30% within 2 years of implantation. This is in spite of the fact that these short components are shortened versions of existing successful non-cemented designs. The mode of initial fixation in non-cemented implants has been investigated. It has been demonstrated that long term survivability is dependent upon osseous integration; and that osseous integration requires secure initial implant fixation. Traditional non-cemented implants achieve initial fixation analogous to that of a nail in a piece of wood: friction and displacement (with resultant hoop stress). Initial fixation, of a traditional non-cemented femoral component, is directly proportional to surface area contact between the implant and endosteal bone and/or three point fixation. By reducing stem length, contact area may be significantly reduced, thereby increasing stresses over a smaller area of contact. The result of this is to potentially compromise fixation/implant stability against micromotion occurring in the early post-operative period. These stresses are most poorly resisted in flexion/extension and rotational planes about the long axis of the femur. In addition, force applied in an attempt to achieve initial fixation with a short stem may lead to an increased risk of periprosthetic fracture at the time of implantation. We propose that there is an alternative mode of initial fixation, a “rest fit”, that may avoid both the risk of femoral fracture as well as provide better initial implant stability. To assure a maximal initial fixation and resistance to post-operative stresses which may compromise initial implant stability and osseous integration, a short implant should have three distinct geometric features: a medial and lateral flare, a flat posterior surface and a proximal trapezoidal cross section. The first will provide stability against subsidence and varus migration, by resting upon the proximal femur. A flat posterior surface will maximize load transmission to the femur in flexon/extension activities; and an asymmetrical proximal cross-section will provide resistance against rotational stresses about the long axis of the femur during activities such as stairclimbing. Together these features have been throproughly evaluated by FEA and in vitro testing. We are reporting on the shoprt term follow up (2.5 years avg.) first 300 short stems which have employed a “rest fit”. There have been no aseptic failures or revisions for mechanical failure of these implants


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 117 - 117
1 Jan 2016
Park Y Moon Y Lim S Kim D Jang S
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Introduction. Micro-arc oxidation (MAO) is an electrochemical method used to treat metal surfaces. It provides nanoporous pits, and thick oxide layers, and incorporates calcium and phosphorus into the coating layer of titanium alloy. This modification on the surface of titanium alloy by MAO coating would improve the ability of cementless stems to osseointegrate. In spite of these structural and chemical advantages, clinical study of total hip arthroplasty (THA) using MAO coated stem has not yet been reported. In this study, we evaluated the clinical and radiographic results associated with cementless grit-blasted tapered-wedge stems that were identical in geometry but differed with regard to surface treatment with or without MAO coating. Materials & Methods. We performed a retrospective review of 141 THAs using MAO coated stem for a minimum of 5 years and compared them to 219 THAs using the same geometry stem without MAO coating. A cementless Bencox femoral component (Corentec, Seoul, Korea) was used in all hips. It is made of titanium alloy with a straight, double wedged, tapered stem with a rectangular cross-section. Surface treatment was performed using grit blasting with a roughness of 5.5ųm that was available either with or without MAO coating. Clinical and radiographic evaluations were performed preoperatively and at 6 weeks, 3 months, 6 months, and 1 year postoperatively, and then annually. Results. In the MAO coating group, the mean Harris hip score improved from 43.7 points preoperatively to 93.9 points postoperatively. The mean WOMAC score and UCLA activity score at the final follow-up was 17 points (range, 6–34 points) and 6.9 points (range, 5–10 points), respectively. Thigh pain at final follow-up was reported in 2 hips (1.4%), but neither of these hips showed signs of implant loosening or limited daily activities. Complications included one squeaking, one iliopsoas tendonitis, and one deep vein thrombosis. Postoperative Harris hip scores, WOMAC scores, UCLA activity scores, and complication rates did not differ between the two groups. In both groups, no femoral or acetabular component showed radiographic evidence of mechanical loosening, and no components had been revised at the final follow-up. Conclusions. Primary THA using a cementless grit-blasted tapered-wedge stem with MAO coating showed encouraging medium-term outcomes. Further prospective controlled study is required to investigate the long-term implant survival, possible complications, and cost-effectiveness of utilizing MAO coating in THA


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 78 - 78
1 May 2016
Tomaszewski P Eijkenboom J Berahmani S Janssen D Verdonschot N
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INTRODUCTION. Total hip arthroplasty (THA) is a very successful orthopaedic treatment with 15 years implant survival reaching 95%, but decreasing age and increasing life expectancy of THA patients ask for much longer lasting solutions. Shorter and more flexible cementless stems are of high interest as these allow to maintain maximum bone stock and reduce adverse long-term bone remodeling.1 However, decreasing stem length and reducing implant stiffness might compromise the initial stability by excessively increasing interfacial stresses. In general, a good balance between implant stability and reduced stress shielding must be provided to obtain durable THA reconstruction.2. This finite element (FE) study aimed to evaluate primary stability and bone remodeling of a new design of short hip implant with solid and U-shaped cross-section. MATERIALS AND METHODS. The long tapered Quadra-H stem and the short SMS implants (Medacta International, Castel San Pietro, Switzerland) were compared in this study (Figure 1). A FE model of a femur was based on calibrated CT data of an 81 year-old male (osteopenic bone quality). Both titanium alloy implants were assigned an elastic modulus of 105 GPa and the Poisson's ratios were set to 0.3. Initial stability simulations included the hip joint force and all muscle loads during a full cycle of normal walking as calculated in AnyBody software (Anybody Technology AS, Denmark), whereas the remodeling simulation used the peak loads from normal walking and stair climbing activities. Initial stability results are presented as micromotions on the implant surface with a threshold of 40 µm.3 Bone remodeling outcomes are represented in a form of simulated Dual X-ray Absorptiometry (DEXA) scans and the quantitative bone mineral density (BMD) changes in 7 periprosthetic zones. RESULTS. The U-shaped SMS implant showed slightly higher micromotions (2.7% surface area exceeding 40 µm) than the Quadra-H stem (0.2%), whereas micromotions of solid SMS were considerably higher (8.4%) (Figure 2). The largest micromotions were found on medial side of all implants. The smallest bone loss one year post-operatively was predicted around the U-shaped SMS implant. Proximal zones (1, 6 and 7) showed the largest bone loss with average of 9.9%, 11.8% and 12.8% for the U-shaped SMS, solid SMS and Quadra-H respectively (Figure 3). The bone remodeling prediction for the Quadra-H stem was in good agreement with clinical DEXA measurements (overall bone loss of 5.5% vs. 5.7). CONCLUSION. The U-shaped SMS implant is clearly superior to its solid version and has potential to provide comparable initial stability as the long Quadra-H stem and considerably better long-term bone stock preservation


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 56 - 56
1 Jan 2016
Moussa H Scemama C Kerboull L
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Introduction. Excellent long-term survival rates associated with the absence of stem subsidence have been achieved with total hip arthroplasty (THA) using femoral components cemented line-to-line (“French Paradox”). Recently, short stems have been introduced in order to preserve diaphyseal bone and to accommodate to minimal invasive THA and a variety of clinical situations. The aim of the current study was to quantify the rotational and tilting stability of a Kerboull stem of varying length after line-to-line cementation using a validated in-vitro model. Materials & methods. The femoral component made of M30NW stainless steel was derived from the original Kerboull stem. It had a double taper, a highly polished surface, and a quadrangular cross-section. Four stem lengths were designed from the original length with a distal reduction of 6, 12, 17 and 22%, whereas the proximal body geometry of the implant remained unaffected. For each stem length, five specimens were implanted into a non-canal synthetic femoral model. The femoral preparation was performed in order to obtain rotational and tilting stability of the stem prior to the line-to-line cementation. Spatial micro-motions of the specimens were investigated using a validated rotational measuring set-up. In addition, in a second separate step, the specimens were exposed to a ventro-dorsal moment to mimic varus-valgus moment. Statistical analysis was performed using ANOVA with Fisher PLSD. Results. The maximum torque transfer from the stem within the cement mantle to the composite femur occurred at the level of the lesser trochanter, whereas the lowest torque transfer was observed at the tip of the stem. The relative movement at the tip was significantly greater for the original length when compared to 6 and 12% length reduction (p = 0.036 and 0.033, respectively). The 12% reduction resulted in a significant lower mean overall movement when compared to the original length (p = 0.044). The tilting behavior according to the stem lengths indicated that proximal bending value was significantly increased for 17% reduction when compared to 6% and 12% reduction (p = 0.035 and 0.032, respectively). Bending of the tip of the stem was in the same direction as the shoulder, indicating a backlash from the tip. At the tip, relative bending was increased when compared to the previous length up to 12% reduction and then decreased. However, the difference was not significant (p <0.05). Discussion & conclusion. The stem lengths evaluated in the current study showed similar results to previously reported cemented stems of different designs, indicating a close fixation to composite bone with small relative movement. Both 6 and 12% shortened versions showed significant reduced relative movement at the tip when compared to the original length, suggesting a limited role for the tip in terms of rotational stability. Regarding the medio-lateral torque, the stems always reacted with a backlash and did not tilt like a rigid body. Although not significant, the distal bending tended to increase with reduced length. These findings led us to develop a Kerboull stem with 12% distal reduction that is currently under clinical trial


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 153 - 153
1 Dec 2013
Zeng P Rainforth WM Rana A Thompson R Fischer A
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With its high wear and corrosion resistance, CoCrMo alloy has been widely used for metal-on-metal total hip replacements (THRs). However, the use of the metal-on-metal implants has dropped substantially as a result of several alerts issued by the Medicines and Healthcare products Regulatory Agency (MHRA) due to concern on metal ion release [1]. However, some of the first generation of metal-on-metal THRs have lasted for more than 20 years [2]. It is far from clear why some MoM joints have survived, while other failed. It is known that dynamic changes occur at the metal surface during articulation. For example, a nanocrystalline layer has been reported on the topmost surface of both in vivo and in vitro CoCrMo THRs [3, 4] but it is not known whether this layer is beneficial or detrimental. The current work focuses on the sub-surface damage evolution of explanted MoM hips, which is compared to in vitro tested CoCrMo hip prostheses. Site-specific TEM cross-section of both in vivo and in vitro CoCrMo samples were prepared by focused ion beam (FIB) in situ lift-out method (Quanta 200 3D with Omniprobe, FEI, the Netherlands). TEM of the FIB specimens was performed on various microscopes. Routine bright field imaging was performed on a Tecnai 20 (FEI, the Netherland) operating at 200 kV, while high resolution transmission electron microscopy (HRTEM) of the nanocrystalline layer and other surface species was undertaken on a Jeol 2010F (Jeol, Japan) operating at 200 kV. A nanocrystalline layer (which was not present on the starting surfaces) was observed on both explanted in vivo and in vitro tested materials. For the explanted joints, the nanocrystalline layer was thin (a few 100 nm) and the extent did not appear to correlate with the local wear rate. For in vitro samples, the nanocrystalline layer was thicker (up to micron). HRTEM from this layer are shown in Fig. 1 and Fig. 2. The nanocrystallite size was ∼5 nm and appeared to be a mixture of face centred cubic and hexagonal close packed phases. The formation of the nanocrystalline layer and its correlation with wear behaviour are discussed


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 106 - 106
1 Dec 2013
Kluess D Ruther C Gabler C Mittelmeier W Bader R
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Clinically applied methods of assessing implant fixation and implant loosening are of sub-optimal precision, leading to the risk of unsecure indication of revision surgery and late recognition of bone defects. Loosening diagnosis involving measuring the eigenfrequencies of implants has its roots in the field of dentistry. The changing of the eigenfrequencies of the implant-bone-system due to the loosening state can be measured as vibrations or structure-borne sound. In research, vibrometry was studied using an external shaker to excite the femur-stem-system of total hip replacements and to measure the resulting frequencies by integrated accelerometers or by ultrasound. Since proper excitation of implant components seems a major challenge in vibrometry, we developed a non-invasive method of internal excitation creating an acoustic source directly inside the implant. In the concept proposed for clinical use, an oscillator is integrated in the implant, e.g. the femoral stem of a total hip replacement. The oscillator consists of a magnetic or magnetisable spherical body which is fixed on a flat steel spring and is excited electromagnetically by a coil placed outside the patient. The oscillator impinges inside the implant and excites this to vibrate in its eigenfrequency. The excitation within the bending modes of the implant leads to a sound emission to the surrounding bone and soft tissue. The sound waves are detected by an acoustic sensor which is applied on the patient's skin. Differences in the signal generated result from varying level of implant fixation. The sensor principle was tested in porcine foreleg specimens with a custom-made implant. Influence of the measurement location at the porcine skin and different levels of fixation were investigated (press-fit, slight loosening, advanced loosening) and compared to the pull-out strength of the implant. Evaluation of different parameters, especially the frequency spectrum resulted in differences of up to 12% for the comparison between press-fit and slight loosening, and 30% between press-fit and advanced loosening. A significant correlation between the measured frequency and the pull-out strength for different levels of fixation was found. Based on these findings, an animal study with sensor-equipped bone implants was initiated using a rabbit model. The implants comprised an octagonal cross-section and were implanted into a circular drill hole at the distal femur. Thereby, definite gaps were realized between bone and implant initially. After implantation, the bone growth around the implant started and the gaps were successively closed over postoperative period. Consequently, since the tests had been started with a loose implant followed by its bony integration, a reverse loosening situation was simulated. In weekly measurements of the eigenfrequencies using the excitation and sensor system, the acoustic signals were followed up. Finally, after periods of 4 and 12 weeks after implantation, the animals were sacrificed and pull-out tests of the implants were performed to measure the implant fixation. The measured implant fixation strengths at the endpoint of each animal trial were correlated with the acoustic signals recorded


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 134 - 134
1 Dec 2013
Nadorf J Graage JD Kretzer JP Jakubowitz E Kinkel S
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Introduction:. Extensive bone defects of the proximal femur e.g. due to aseptic loosening might require the implantation of megaprostheses. In the literature high loosening rates of such megaprostheses have been reported. However, different fixation methods have been developed to achieve adequate implant stability, which is reflected by differing design characteristics of the commonly used implants. Yet, a biomechanical comparison of these designs has not been reported. The aim of our study was to analyse potential differences in the biomechanical behaviour of three megaprostheses with different designs by measuring the primary rotational stability in vitro. Methods:. Four different stem designs [Group A: Megasystem-C® (Link), Group B: MUTARS®(Implantcast), Group C: GMRS™ (Stryker) and Group D: Segmental System (Zimmer); see Fig. 1] were implanted into 16 Sawbones® after generating a segmental AAOS Typ 2 defect. Using an established method to analyse the rotational stability, a cyclic axial torque of ± 7.0 Nm along the longitudinal stem axis was applied. Micromotions were measured at defined levels of the bone and the implant [Fig. 2]. The calculation of relative micromotions at the bone-implant interface allowed classifying the rotational implant stability. Results:. All four different implants exhibited low micromotions, indicating adequate primary stability. Lowest micromotions for all designs were located near the femoral isthmus [Fig. 3]. The extent of primary stability and the global implant fixation pattern differed considerably and could be related to the different design concepts. Discussion:. Compared to other implant designs, all stems resulted in low relative motions regardless their design. The conical Megasystem-C® stem seems to lock in the proximal isthmus of the femur, whereas the MUTARS® stem seems to have a total fixation. Its hexagonal cross-section might have a good interlocking effect against rotational force application. Similarly, the GMRS™ stem shows a total fixation with little tendency to the distal part. The very rough porous-coated surface seems to generate a comparable fixation method to the hexagonal MUTARS® stem. However, the four longitudinal expansions in the proximal part of the GMRS™ stem might not have such a high rotational stability effect as expected. Compared to the other stems, the Segmental System stem showed very low relative micromotions in the proximal part. This sharp fluted stem seems to engrave itself into the bone. Within this study all stems seemed to achieve an adequate primary rotational stability. We could show that stem design could qualitatively and quantitatively influence the initial fixation behavior of megaprostheses regarding biomechanical tests, like primary stability measurements in synthetic femurs. These experiences should be considered regarding the choice of stem fixation design in specific defect situations


Bone & Joint Research
Vol. 10, Issue 7 | Pages 425 - 436
16 Jul 2021
Frommer A Roedl R Gosheger G Hasselmann J Fuest C Toporowski G Laufer A Tretow H Schulze M Vogt B

Aims

This study aims to enhance understanding of clinical and radiological consequences and involved mechanisms that led to corrosion of the Precice Stryde (Stryde) intramedullary lengthening nail in the post market surveillance era of the device. Between 2018 and 2021 more than 2,000 Stryde nails have been implanted worldwide. However, the outcome of treatment with the Stryde system is insufficiently reported.

Methods

This is a retrospective single-centre study analyzing outcome of 57 consecutive lengthening procedures performed with the Stryde nail at the authors’ institution from February 2019 until November 2020. Macro- and microscopic metallographic analysis of four retrieved nails was conducted. To investigate observed corrosion at telescoping junction, scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDX) were performed.