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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 331 - 331
1 Dec 2013
Guo S Baskaradas A Holloway I
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Introduction. Reconstructing acetabular defects in revision hip arthroplasty can be challenging. Small, contained defects can be successfully reconstructed with porous-coated cups without bone grafts. With larger uncontained defects, a cementless cup even with screws, will not engage with sufficient host bone to provide enough stability. Porous titanium augments were originally designed to be used with cementless porous titanium cups, and there is a scarcity of literature on their usage in cemented cups with bone grafting. Methods. We retrospectively reviewed five hips (four patients – 3 women, 1 man; mean age 65 years) in which we reconstructed the acetabulum with a titanium augment (Biomet, IN, USA) as a support for impaction bone grafting and cemented acetabular cups (Figure 1). All defects were classified according to Paprosky classification. Radiographic signs of osseointegration were graded according to Moore grading. Quality of life was measured with the Oxford Hip Score. Results. At a minimum of one year follow-up, none of the patients required any further surgery for aseptic loosening or re-revision. The Oxford Hip Scores generally improved and two of the patients were very satisfied with the overall outcome of the surgery and would have undergone the surgery again for a similar problem. The patient that underwent bilateral acetabular reconstruction during a period one month, scored lowered than the other patients and was less satisfied with the outcome. Radiographs at the latest follow-up revealed incorporation of the augment with mean change in acetabular component inclination of less than 1° and cup migration of less than 5 mm in both horizontal and vertical axes. Discussion. Acetabular reconstruction using porous titanium augments as a support for bone grafting and cemented acetabular cups can be an effective way of managing uncontained structural acetabular defect, with biocompatibility and osteoinducive characteristics. The early results are promising but longer follow-up is required


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 109 - 109
1 May 2016
Tucker J Gordon J Zanes R Zuskov A Cirone J Vinciguerra J Bloebaum R Soslowsky L
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INTRODUCTION. Rotator cuff tears are common injuries which often require surgical repair. Unfortunately, repairs often fail [1] and improved repair strength is essential. P2 Porous titanium (DJO Surgical, Austin TX) has been shown to promote osseointegration [2,3] and subdermal integration [4]. However, the ability of P2Porous titanium to aid in supraspinatus tendon-to-bone repair has not been evaluated. Therefore, the purpose of this study was to investigate P2 implants used to augment supraspinatus tendon-to-bone repair in a rat model [5]. We hypothesized that supraspinatus tendon-to-bone repairs with P2 implants would allow for ingrowth and increased repair strength when compared to standard repair alone. METHODS. Thirty-four adult male Sprague-Dawley rats were used (IACUC approved). Rats received bilateral supraspinatus detachment and repair with one limb receiving P2 implant. Animals were sacrificed at time 0 (n=3), 2 weeks (n=8), 4 weeks (n=9) and 12 weeks (n=14). Limbs were either dissected for histological and SEM analysis or mechanical testing as described previously [5]. Specimens for histology and SEM were embedded in PMMA for tissue-implant interface analysis. Specimens were first viewed in SEM under BSE to detect bony ingrowth, then stained with Sanderson's Rapid Bone Stain and viewed under transmitted and polarized light for tissue ingrowth. Comparisons were made using Student's t-tests with significance at p≤0.05. RESULTS. No differences in cross-sectional area were detected at any time point (Fig 1A). Percent relaxation was significantly increased in the P2 group at 2 weeks, but not at 4 and 12 weeks (Fig 1B). Maximum load was significantly increased in the P2 group at 2 weeks, but not at 4 weeks (Fig 1C – maximum load not reported due to failure at grip at 12 weeks). Modulus was significantly increased in the P2 group at 4 weeks, but not at 2 or 12 weeks (Fig 1D). No differences were detected in stiffness at any time point (data not shown). BSE analysis demonstrated bone ingrowth (Fig 2) and histological analysis showed soft tissue integration (Fig 3). DISCUSSION. Results indicate superior mechanical properties in the P2 group at 2 and 4 weeks, and tissue ingrowth at all time points. Importantly, at 2 weeks, the P2group had 76% increased maximum load compared to standard repair. As supraspinatus tendon re-tears are extremely common early [1] and occur at the tendon-to-bone interface, this finding supports the reduction of re-tear risk with the P2 implant. Although no differences were detected in maximum load at 4 weeks, the increase at 2 weeks denotes that P2 implants improved early tendon-to-bone healing. Additionally, at 4 weeks, the P2 implant group had significantly increased elastic modulus, further supporting increased mechanical properties due to the P2 implant. Clinically, improved early healing might allow faster rehabilitation and associated recovery. This study demonstrates that the P2 implant improves tendon-to-bone healing up to 4 weeks (with no detrimental effects at longer time points), suggesting that P2 porous titanium may be of benefit for use in clinical rotator cuff repairs


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 9 - 9
1 Apr 2019
Cavagnaro L Burastero G Chiarlone F Felli L
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Introduction. Bone loss management represents one of the most challenging issues for the orthopaedic surgeon. In most cases, stems, structural allograft, TMcones, and sleeves are adequate to allow optimal implant stability and durable fixation. In selected cases of wide metadiaphyseal bone defects, these devices do not provide proper intraoperative stability. In such scenarios, further steps are needed and include complex modular reconstruction, substitution with megaprosthesis (exposing patients at high risk of early failure) or joint arthrodesis that can yield unacceptable results. The aim of this paper is to present early results obtained with a new custom-made implant for complex metadiaphyseal bone defects management in knee revision surgery. By means of case presentations the authors would highlight the possibilities and technical notes of this novel device in complex knee revision surgery. Methods. Since2015, 8 custom-made porous titanium devices were implanted for massive bone defect management in 6 knee arthroplasty revision procedures. Five patients were staged revision for periprosthetic joint infection (PJI) and one patient underwent a staged revision for post-traumatic septic arthritis. Main demographic and surgical data were collected. Clinical (Range of Movement [ROM], Knee Society Score [KSS] and Oxford Knee Score [OKS]), radiological findings and complications were recorded at different time points and statistically evaluated. Mean follow up was 19.5 ± 9.6months. Results. The study group included 4 males and 2 females with a mean age of 63.7 ± 5.5 years and a mean Body Mass Index of 29.3 ± 4.1. Globally, the mean number of previous surgeries was 4.8 ± 2.7. The custom made device was combined with a hinged prosthesis in 5 cases and with a constrained condylar implant in 1 patient. Hybrid fixation was used in all cases. The mean KSS and OKS of the entire population improved significantly from 35.3 ±6.5 and 19.2 ±3.5 preoperatively to 85.8 ±4.0 and 39.3 ±3.1 at the time of last follow-up evaluation (p<0.01). The range of motion improved from 46.7 ±9.8 of mean preoperative flexion and 7.8 ±6.8 of mean preoperative flexion contracture to 93.3 ±10.3 and 1.2 ±2.9 respectively (p<0.01). Radiological analysis showed no migration or implant loosening. No intraoperative or postoperative complication was recorded. One patient required a prolonged antibiotic therapy for positive culture samples of sonication of the retrieved spacer. No implant mismatch between the preoperative planning and the final implant was reported. Conclusion. The presented custom-made implant showed promising early clinical and radiological results. In extremely selected cases, this new device can be considered a safe and effective surgical step between “off the shelf” reconstruction implants and knee substitution with a tumor megaprosthesis. Accurate surgical planning and intraoperative management of soft tissues and residual bone stock are of paramount importance


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 56 - 56
1 Feb 2017
Buzhardt P Smith L Bhowmik-Stoker M Stimac J
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Introduction. The use of cementless TKA's has been gradually increasing over the past several years given the increasing life expectancy of our patient population. Cementless TKA's have not been rapidly adopted due to the challenges and uncertainty of tibial fixation especially in elderly patients. With the advent of new technologies, the results of cementless TKA's with the potential for long term biologic fixation may now be equivalent or better than cemented TKA's. A highly porous tibial baseplate was developed based on proximal tibial anatomy using CT scans using 3D printing technology with focus on length, location and design of press-fit pegs. Objectives. The purpose of this study was to review the early results with respect to fixation and complications using a new, highly porous cementless tibial baseplate designed for biologic fixation. Methods. One hundred primary cementless TKAs were retrospectively reviewed using a highly porous titanium tibial baseplate. The femoral and patella components were also press-fit using peri-apetite beaded technology. Patients were evaluated at 2 weeks, 3 months, 1 and 2 year for clinical and radiographic outcomes along with any early (within 90 day) and 2 year complications. Postoperative protocol consisted of immediate full weightbearing, as tolerated. Radiographs were evaluated for biological fixation and radiolucent lines. Results. There were 68 females and 32 males with 7 undergoing bilateral TKA. The mean age was 63.8 yrs (range 40–84). The mean BMI was 33.7. Diagnosis in all patients was osteoarthritis. The mean follow up was 24.8 months (range 15 to 33). The mean hospital length of stay was 3.2 days (range 2–7). The mean pre operative flexion was 105.8 degrees which improved to 117.9 degrees at latest follow up. KSS scores improved significantly in all patients. There were no postoperative transfusions in this group. All patients developed good radiographic fixation and stability of the tibial baseplate (Figure 1). There were no cases of loosening of the baseplate or infections in this series. Within 90 days, one patient developed a non fatal DVT and one patient was revised due to instability from a CR to a PS femur with the baseplate intact. At 8 months post-op, one patient had a liner exchange for MPFL rupture with a subluxating patella. At 18 months post-op, one patient had a liner exchange due to instability and extensor mechanism rupture. In both cases the baseplate was not revised. Conclusions. Study results indicate cementless fixation using this baseplate is a viable option with good short term clinical results and no cases of aseptic loosening at 2 years. Early stability, pain relief and good ROM were shown. Long term data will be required to determine the overall benefits of this highly porous TKA with biologic fixation versus cemented arthroplasty


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 12 - 12
1 Apr 2018
Moharamzadeh D Piarulli G Molisani D Andreoletti G
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Cementless total knee replacement (TKR) is at the present date a controversial topic. Aim of the study was to compare the effect on tibial periprosthetic bone mineral density (BMD) between different implant materials and designs. During the two-year period between January 2005 and December 2006, we analysed data of 45 patients who underwent consecutively cementless TKR (49 implants) at our Institution for primary osteoarthritis. Data was divided in 2 groups: A) 26 implants with tantalium tibial component (Zimmer NexGen Trabecular Metal. TM. Monoblock); B) 23 implants with porous titanium tibial component (Lima MultiGen. TM. ). Data was comparable per sex, age, BMI, post-op alignment, post-op KSS > 75, absence of major post-op complications. Standard AP x-rays were taken 4 months post-op and 8 years post-op. In order to quantify the reduction of BDM, we determined using ImageJ (an open source software) the Mean Grey Value (MGV) of a specific area on the 4 months- and 8 yrs-postop AP x-rays. Group A and Group B had an average MGV variation of, respectively, 11.79% and 10.51%; there was no statistically significant difference between the two groups. Reduction of BMD in a TKR is known to be a biomechanical response to load and it is conditioned by the alignment of the components and their design. Our study shows that the different materials (porous titanium vs. tantalium), in relation to the different implant design, have a similar effect on the surrounding bone. The overall results show a valid osseointegration in both group of patients


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 60 - 60
1 Feb 2017
Vanacore C Masini M Westrich G Campbell D Robinson K
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Introduction. Acetabular revision surgery remains a technically demanding procedure with higher failure rates than primary total hip arthroplasty (THA). An acetabular component with three dimensional porous titanium and anatomic screw holes (Figure 1) was designed to allow the cup to be positioned anatomically and provide reliable fixation. Methods. A prospective multicenter study of 193 cases (190 patients) was conducted to assess the midterm clinical outcomes of the revision titanium acetabular shell. Radiographs, demographics, Harris Hip Score (HHS), and Short Form 36 (SF-36) were collected preoperatively, at 6 weeks, 3 months, and annually thereafter to 5 years. The mean duration of follow-up was 3.36 years. The Paprosky classification was assessed intraoperatively. Short Form 6D (SF-6D) utility values were obtained by transforming SF-36 scores through the Brazier method and were analyzed for effect size. Results. At time of surgery, mean patient age was 63.5 years and mean BMI was 28.1. 69 of the 193 cases were graded as 3A or 3B according to the Paprosky classification method. For all cases, Harris Hip Scores improved significantly (p < 0.001) from a preoperative mean score of 53.60 to a mean score of 86.15 at 1 year. These significant gains were maintained through 5 years, with a mean score of 87.35 at the 5-year time point. The Harris Hip Scores for Paprosky 3A and 3B cases also improved significantly (p < 0.001) from a preoperative mean score of 48.11 to a mean score of 85.45 at 1 year. These significant gains were maintained through 5 years, with a mean score of 85.65 at the 5-year time point. Among the radiographs independently reviewed to date, no cup migration or unstable cups have been identified. There were 12 acetabular shell re-revisions reported, for infection (7), aseptic loosening (4) and recurrent dislocation (1). Three of the cases revised for aseptic loosening were Paprosky type 3A, and one was 3B. For all cases, a clinically significant improvement in health utility was achieved by 3 months postoperative, with an effect size of 0.54. Clinically significant scores were maintained throughout the follow-up period, reaching an effect size of 0.64 at 5 years. Effect sizes were larger for cases with Paprosky classifications of 3A and 3B than the overall study population at all time points, reaching clinical significance at 3 months with an effect size of 0.64, and continuing to increase to an effect size of 1.19 at 5 years. Conclusion. Even in patients with severe acetabular defects, next generation highly porous acetabular components with three dimensional porous titanium and anatomic screw holes provide excellent stability, predictable midterm biologic fixation, pain, and reduction, and improved clinical function and health utility


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 14 - 14
1 Apr 2019
Van De Kleut M Athwal G Yuan X Teeter M
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Introduction. Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA). Methods. Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium (Aequalis Ascend Flex, Wright Medical Group, Memphis, TN, USA) for primary reverse total shoulder arthroplasty. Following surgery, partients are imaged using RSA, a calibrated, stereo x-ray technique, at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years. Migration of the humeral stem and glenosphere at each time point is compared to baseline. Preliminary results are presented, with 15 patients having reached the 6-month time point by presentation. Results. Implant migration of ten participants at the 3-month time point is presented. Maximum total point motion (MTPM) is a measure of translation and rotation of the point on the implant that has moved the most from baseline. Average MTPM ± SD of the humeral stem is 1.18 ± 0.65 mm and 0.98 ± 0.46 mm for press-fit (n = 6) and cemented (n = 4) stems, respectively; and 0.25 ± 0.09 mm and 0.47 ± 0.24 mm for bone graft (n = 4) and porous titanium (n = 6) glenosphere fixations, respectively, at the 3-month time point. Conclusion. There is a trend towards increased migration with the use of press-fit humeral stems and porous titanium glenosphere fixation, though no conclusions can be made from the current sample size. Further, though differences in migration magnitude may be observed at early postoperative time points, it is expected that all fixation techniques will show stability from 1 to 2 years postoperatively


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 7 - 7
1 Feb 2021
Glenday J Gonzalez FQ Wright T Lipman J Sculco P Vigdorchik J
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Introduction. Varus alignment in total knee replacement (TKR) results in a larger portion of the joint load carried by the medial compartment. [1]. Increased burden on the medial compartment could negatively impact the implant fixation, especially for cementless TKR that requires bone ingrowth. Our aim was to quantify the effect varus alignment on the bone-implant interaction of cementless tibial baseplates. To this end, we evaluated the bone-implant micromotion and the amount of bone at risk of failure. [2,3]. Methods. Finite element models (Fig.1) were developed from pre-operative CT scans of the tibiae of 11 female patients with osteoarthritis (age: 58–77 years). We sought to compare two loading conditions from Smith et al.;. [1]. these corresponded to a mechanically aligned knee and a knee with 4° of varus. Consequently, we virtually implanted each model with a two-peg cementless baseplate following two tibial alignment strategies: mechanical alignment (i.e., perpendicular to the tibial mechanical axis) and 2° tibial varus alignment (the femoral resection accounts for additional 2° varus). The baseplate was modeled as solid titanium (E=114.3 GPa; v=0.33). The pegs and a 1.2 mm layer on the bone-contact surface were modeled as 3D-printed porous titanium (E=1.1 GPa; v=0.3). Bone material properties were non-homogeneous, determined from the CT scans using relationships specific to the proximal tibia. [2,4]. The bone-implant interface was modelled as frictional with friction coefficients for solid and porous titanium of 0.6 and 1.1, respectively. The tibia was fixed 77 mm distal to the resection. For mechanical alignment, instrumented TKR loads previously measured in vivo. [5]. were applied to the top of the baseplate throughout level gait in 2% intervals (Fig.1a). For varus alignment, the varus/valgus moment was modified to match the ratio of medial-lateral force distribution from Smith et al. [1]. (Fig.1b). Results. For both alignments and all bones, the largest micromotion and amount of bone at risk of failure occurred during mid stance, at 16% of gait (Figs.2,3). Peak micromotion, located at the antero-lateral edge of the baseplate, was 153±32 µm and 273±48 µm for mechanical and varus alignment, respectively. The area of the baseplate with micromotion above 40 µm (the threshold for bone ingrowth. [3]. ) was 28±5% and 41±4% for mechanical and varus alignment, respectively. The amount of bone at risk of failure at the bone-implant interface was 0.5±0.3% and 0.8±0.3% for the mechanical and varus alignment, respectively. Discussion. The peak micromotion and the baseplate area with micromotion above 40 µm increased with varus alignment compared to mechanical alignment. Furthermore, the amount of bone at risk of failure, although small for both alignments, was greater for varus alignment. These results suggest that varus alignment, consisting of a combination of femoral and tibial alignment, may negatively impact bone ingrowth and increase the risk of bone failure for cementless tibial baseplates of this TKR design


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 119 - 119
1 Sep 2012
Nakamura T
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It is very important to fix implant to bone. Bioactive materials as hydroxyapatite or glass-ceramics have bone-bonding ability. Hydroxyapatite-coating is applied to cementless THA or TKA. I and coworkers investigated bone-bonding mechanism of bioactive material and found that bone-like apatite formation play key role for bonding. If the surface of metal is changed to form apatite on it in body, the inert metal changes into bone-bonding material. We developed alkaline and heat treatment of titanium to change titanium to bone –bonding material as follows. At first, titanium is dipped in 5N NaOH solution for 24 hours, at second the metal is washed in pure water and finally it is sintered in 500 degree C for 2 hours. The treated surface has bioactivity, bone bonding ability like hydroxyapatite. The advantage of this treatment over hydroxyapatite-coating procedure is to treat the porous surface without any change of pore figures. As to hydroxyapatite-coating procedure, pore of the small diameter is filled with hydroxyapatite and pore figures are change. We applied this alkaline and heat treatment to cementless THA and its good results of more than ten years was reported. Porous titanium can be changed to bioactive material by alkaline and heat treatment. This bioactive porous titanium was found to have a property of material-induced osteoinduction, that is, the bone formation in pore of porous titanium implanted in canine back muscle. They can be used for bone substitute for big bone defect. We used two procedures to make porous titanium, sintering of titanium powder with spacer particle of ammonium sulfate and selective lazar melting. The latter procedure can produce any type of pore structure of titanium. Selective laser melting was employed to fabricate porous Ti implants (diameter 3.3 mm, length 15 mm) with a channel structure comprising four longitudinal square channels, representing pores, of different diagonal widths, 500, 600, 900, and 1200 micrometer. These were then subjected to chemical and heat treatments to induce bioactivity. Significant osteoinduction was observed in widths 500 and 600 micrometer, with the highest observed osteoinduction occurring at 5 mm from the end of the implants. A distance of 5 mm probably provides a favorable balance between blood circulation and fluid movement. New bioactive bone cement is another topic of the application of bioactive titanium in this lecture. The bone cement contains barium sulphate for radiocontrast. We developed a procedure to replace barium sulphate with bioactive titanium powder. This new bone cement has not only better biocompatibility than conventional cement but also bone bonding ability. It is potent material for the fixation of implant to bone. I will speak the evaluation of this cement using canine model of THA


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 70 - 70
1 Feb 2020
Huang Y Zhou Y Yang D Tang H Shao H Guo S
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Aims. Only a small number of studies exist that report the results of EBM-produced porous coated trabecular titanium cups in primary total hip arthroplasty (THA). This study aims to investigate the patient satisfaction level, clinical function and radiographic outcomes of the patients who underwent THA using an EBM-produced porous coated titanium cup. Patients and Methods. A total of 32 patients who underwent primary THA with using an EBM-produced porous coated titanium cup from five hospitals between May and December, 2012 were retrospectively reviewed. Five patients were lost prior to the minimum 6-year follow-up. Clinical and radiographic outcomes were analyzed with an average follow-up of 81.48 (range: 77.00–87.00) months. Results. The median HHS and SF-36 scores improved significantly while the WOMAC Osteoarthritis Index decreased significantly at the latest follow-up (p<0.001). Eighteen (66.7%) patients rated their satisfaction level as very satisfied, 6 (22.2%) as satisfied, 2 (7.4%) as neutral and 1(3.7%) as dissatisfied. No intraoperative or postoperative complications were identified, including aseptic cup loosening, hip dislocation, periprosthetic joint infection, periprosthetic fracture, nerve palsy, hematoma. At the latest follow-up, all cups were considered to have achieved fixation via bone ingrowth with three or more of the five signs occurring in the most recent X-ray. However, three cups revealed radiolucent lines with a width of less than 1 mm. These radiolucent lines were distributed in the DeLee-Charnley zone 1 in 1 patient, zone 3 in another patient and the area between zone1 and zone 2 in an additional patient. The latest postoperative centers of rotation were restored nearly to the anatomic center of rotation both vertically and horizontally and the acetabular cups obtained satisfactory orientation postoperatively. Conclusions. The mid-term follow-up of patients who underwent primary THA using EBM-produced porous coated titanium cups demonstrated favorable patient satisfaction, clinical function and adequate biological fixation. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_9 | Pages 11 - 11
1 Jun 2021
Munford M Jeffers J
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OSSTEC is a pre-spin-out venture at Imperial College London seeking industry feedback on our orthopaedic implants which maintain bone quality in the long term. Existing orthopaedic implants provide successful treatment for knee osteoarthritis, however, they cause loss of bone quality over time, leading to more dangerous and expensive revision surgeries and high implant failure rates in young patients. OSSTEC tibial implants stimulate healthy bone growth allowing simple primary revision surgery which will provide value for all stakeholders. This could allow existing orthopaedics manufacturers to capture high growth in existing and emerging markets while offering hospitals and surgeons a safer revision treatment for patients and a 35% annual saving on lifetime costs. For patients, our implant technology could mean additional years of quality life by revising patients to a primary TKA before full revision surgery. Our implants use patent-filed additive manufacturing technology to restore a healthy mechanical environment in the proximal tibia; stimulating long term bone growth. Proven benefits of this technology include increased bone formation and osseointegration, shown in an animal model, and restoration of native load transfer, shown in a human cadaveric model. This technology could help capture the large annual growth (24%) currently seen in the cementless knee reconstruction market, worth $1.2B. Furthermore, analysis suggests an additional market of currently untreated younger patients exists, worth £0.8B and growing by 18% annually. Making revision surgery and therefore treatment of younger patients easier would enable access to this market. We aim to offer improved patient treatment via B2B sales of implants to existing orthopaedic manufacturer partners, who would then provide them with instrumentation to hospitals and surgeons. Existing implant materials provide good options for patient treatments, however OSSTEC's porous titanium structures offer unique competitive advantages; combining options for modular design, cementless fixation, initial bone fixation and crucially long term bone maintenance. Speaking to surgeons across global markets shows that many surgeons are keen to pursue bone preserving surgeries and the use of porous implants. Furthermore, there is a growing demand to treat young patients (with 25% growth in patients younger than 65 over the past 10 years) and to use cementless knee treatments, where patient volume has doubled in the past 4 years and is following trends in hip treatments. Our team includes engineers and consultant surgeons who have experience developing multiple orthopaedic implants which have treated over 200,000 patients. To date we have raised £175,000 for the research and development of these implants and we hope to gain insight from industry professionals before further development towards our aim to begin trials for regulatory approval in 2026. OSSTEC implants provide a way to stimulate bone growth after surgery to reduce revision risk. We hope this could allow orthopaedic manufactures to explore high growth markets while meaning surgeons can treat younger patients in a cost effective way and add quality years to patients' lives


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 175 - 175
1 Jan 2013
Demol J Lenaerts B Leuridan S Delport H
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Introduction. Surgeons are often confronted with large amounts of bone loss during the revision of total hip prostheses. Regularly, porous metals are applied to reconstruct the missing bone. Rapid and extensive bone infiltration into the implant's pores is essential to obtain strong and durable biological fixation. Today, specialised layered manufacturing techniques provide the flexibility to produce custom-made metallic implants with a personalized external shape and a well-controlled internal network of interconnected pores. In this study, bone ingrowth in porous titanium structures that were manufactured by selective laser melting (SLM) was evaluated in an in vivo goat model. Methods. Cylindrical Ti6Al4V constructs (Ø8mm × 14mm, porosity 75%) with or without hydroxyapatite coating were implanted in six Saanen goats. Three holes were drilled in the subchondral bone of each tibia and femur. Constructs were inserted into the holes in a press-fit manner. Resonance frequency analysis was used to measure construct stability. At 3, 6 and 9 weeks after surgery, fluorochrome labels were injected. After 6 and 12 weeks, samples were explanted. Some samples were scanned with micro-CT and subsequently sectioned for histological analysis. The others were used for pull-out tests. Results. Resonance frequency analysis indicated a noticeable increase in implant stability. Evaluation of micro-CT and histological data showed bone ingrowth for all goats at 6 and 12 weeks. Most bone ingrowth occurred during the first 6 weeks, which was followed by a slight increase between week 6 and 12. Fluorochrome labeling confirmed these results. Pull-out tests showed an increased fixation at the bone-implant interface. Conclusion. Porous titanium structures manufactured by SLM have good osseointegration characteristics. As custom-made bone augments, they provide a promising approach to the reconstruction of severe bone defects


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 22 - 22
1 Feb 2020
Van De Kleut M Athwal G Yuan X Teeter M
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Introduction. Reverse total shoulder arthroplasty (RTSA) is rapidly being adopted as the standard procedure for a growing number of shoulder arthropathies. Though short-term outcomes are promising, mid- and long-term follow-ups present a number of complications – among them, humeral stem and glenosphere component loosening. Though not the primary complication, previously reported aseptic loosening required revision in 100% of cases. As the number of patients undergoing RTSA increases, especially in the younger population, it is important for surgeons to identify and utilize prostheses with stable long-term fixation. It has previously been shown in the hip and knee literature that implant migration in the first two years following surgery is predictive of later failure due to loosening in the 5=10-year postoperative window. The purpose of this study is to, for the first time, evaluate the pattern and total magnitude of implant migration in reverse shoulder arthroplasty using the gold standard imaging technique radiostereometric analysis (RSA). Methods. Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium for primary reverse total shoulder arthroplasty. Following surgery, participants are imaged using RSA, a calibrated, stereo x-ray technique. Radiographs are acquired at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years. Migration of the humeral stem and glenosphere at each time point is compared to baseline. Migration of the prostheses is independently compared between humeral stem fixation groups and glenosphere fixation groups using a two-way repeated measures ANOVA with Tukey's test for multiple comparisons. Results. Follow-ups are ongoing and preliminary results are presented. Significant differences were observed at the 6-month and 1-year time points for superior-inferior translation (p = 0.0067, p = 0.0048), and total three-dimensional translation (p = 0.0011, p = 0.0272) between humeral stems, with press-fit humeral stems subsiding significantly more than cemented stems. Migration between the 6-month and 1-year time points was minimal for both stem fixation groups (less than 0.2 mm). No significant differences were observed along any axis at any time point for the glenosphere fixation groups. Conclusion. There is a trend towards increased subsidence with the use of press-fit stems compared to cemented stems in the first six months postoperatively, as is expected. Both implant fixation techniques demonstrate stability from six months through one year, and this trend is expected through two-year follow-up. Similarly, both glenosphere fixation techniques demonstrate immediate and stable fixation through one year


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_8 | Pages 117 - 117
1 May 2019
Lachiewicz P
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A well-fixed uncemented acetabular component is most commonly removed for chronic infection, malposition with recurrent dislocation, and osteolysis. However, other cups may have to be removed for a broken locking mechanism, a bad “track record”, and for metal-on-metal articulation problems. Modern uncemented acetabular components are hemispheres which have 3-dimensional ingrowth patterns. Coatings include titanium or cobalt-chromium alloy beads, mesh, and now the so-called “enhanced coatings”, such as tantalum trabecular metal, various highly porous titanium metals, and 3-D printed metal coatings. These usually pose a problem for safe removal without fracture of the pelvis or creation of notable bone deficiency. Preoperative planning is essential for safe and efficient removal of these well-fixed components. Strongly consider getting the operative report, component “stickers”, and contacting the implant manufacturer for information. There should a preoperative check list of the equipment and trial implants needed, including various screwdrivers, trial liners, and a chisel system. The first step in component removal is excellent 360-degree exposure of the acetabular rim, and this can be accomplished by several approaches. Then, the acetabular polyethylene liner is removed; a liner that is cemented into a porous shell can be “reamed out” using a specific device. Following this, any central or peripheral screws are removed; broken or stripped screw heads add an additional challenge. A trial acetabular liner is placed, and an acetabular curved chisel system is used. There are two manufacturers of this type of system. Both require the known outer acetabular diameter and the inner diameter of the trial liner. With the curved chisel system and patience, well-fixed components can be safely removed, and the size of the next acetabular component to be implanted is usually 4mm larger than the one removed. There are special inserts for removal of monobloc metal shells. Remember that removal of these well-fixed components is more difficult in patients compared to models, and is just the first step of a successful acetabular revision


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 80 - 80
1 Feb 2020
Robotti P Luchin V Galeotti F Molinari A
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AM Open Cell porous Ti Structures were investigated for compressive strength, morphology (i.e. pore size, struts size and porosity), and wear resistance with the aim to improve design capability at support of implant manufacturing. Specimens were manufactured in Ti6Al4V using a SLM machine. Struts sizes had nominal diameters of 200µm or 100µm, pores had nominal diameters of 700µm, 1000µm or 1500µm. These dimensions were applied to three different open-cell geometrical configurations: one with unit-cells based on a regular cubic arrangement (Regular), one with a deformed cubic arrangement (Irregular), and one based on a fully random arrangement (Fully Random). Morphological analysis was performed by image analysis applied onto optical and SEM acquired pictures. The analyses estimated the maximum and minimum Feret pores diameter, and the latter was used as one of the key parameters to describe the interconnected network of pores intended for bone colonization. Outcome revealed the systematic oversizing of the actual struts diameter Vs designed diameter; by opposite min. Feret diameters of the pores resulted significantly smaller than nominal pore diameters, thus better fitting within the range of pores dimension acknowledged to favor the osseointegration. Consequently, the actual total porosity is also reduced. Many technologic factors are responsible for the morphologic differences design vs actual, among these the influence of melting pool dimension, the struts orientation during building and the layer thickness have a significant impact. Mechanical compression was performed on porous cylinder samples. Test revealed the Yield Strength and Stiffness are highly sensitive to the actual porosity. Deformation behavior follows densification phenomenon at lower porosity, whereas at higher porosity the Gibson-Ashby model fits for most of the structure tested. The relationship among load direction, struts alignment and the collapse behavior of the unit cell geometries are discussed. Stiffness of the porous structure is evaluated in both quasistatic and cyclic compression. Wear was investigated according to Taber test method. The abrasion resistance is measured by scratching a ceramic wheel against the different AM porous structures along a circular path. Metal debris eventually loss were quantified by gravimetric analysis at different number of cycles. Correlation among AM porous structure geometry, porosity and wear loss is discussed. All the tested structures showed a debris loss within the limit suggested by FDA for the porous coating in contact with the bone tissue. The actual AM porous Titanium unit cell geometry and features are a key design input. In combination with all the other design factors of a device they may result helpful in address the stress shielding and prevent metal debris release issues. The study underlines the importance of the research activity in AM to support Design for Additive Manufacturing (DFAM) capability. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_8 | Pages 27 - 27
1 May 2019
Gustke K
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Total knee replacements are being more commonly performed in active younger and obese patients. Fifteen-year survivorship studies demonstrate that cemented total knee replacements have excellent survivorship, with reports of 85 to 97%. Cemented knee arthroplasties are doomed to failure due to loss of cement-bone interlock over time. Inferior survivorship occurs in younger patients and obese patients who would be expected to place increased stress on the bone-cement interfaces. Roentgen stereophotogrammetric analysis (RSA) studies have indicated that cementless fixation should perform better than cemented fixation. However, cementless fixation for total knee replacement has not gained widespread utilization due to the plethora of poor results reported in early series. The poor initial results with cementless total knee replacement have occurred due to poor implant designs such as cobalt chrome porous interfaces, poor initial tibial component stability, lack of continuous porous coating, poor polyethylene, and use of metal-backed patellae. I have used cementless fixation for total knee replacements for young, active, and heavy patients since 1986 when durability over 20 years is desirable. My series of over 1,300 cementless TKAs represents about 20% of the 6,500 total knees I have performed from 1986 to 2017. I have seen initial failures in my series due to the use of metal-backed patellae with thin polyethylene, older generation polyethylene, and use of screws with the tibial components which provide access to the metaphyseal bone for polyethylene wear debris. Overall implant fixation failures were still significantly low due to the use of a highly porous titanium surface on both the tibial and femoral components. With the advent of utilizing implants with continuous porous surfaces and highly crosslinked polyethylene, and elimination of use of metal-backed patellae and tibial screws, I have only had one revision due to aseptic loosening or osteolysis in the last 1,071 cases performed since 2002. Almost 50% of total knees are now performed on patients under the age of 65. A 55-year-old patient has a 30 year life expectancy. Modern total knee replacement design has made biological fixation predictable for young and heavy patients. Because it is a biological interface, it should respond better than cement to the increased stresses that will be applied over many years by our younger, more active and heavier total knee population


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 118 - 118
1 Jun 2018
Rodriguez J
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Bone loss creates a challenge to achieving fixation in revision TKR. Failure to achieve metaphyseal fixation is associated with failure in revision TKR. In the absence of cancellous bone for cement fixation, metaphyseal augments placed without cement have shown promise in achieving fixation. First generation augments were modular solid titanium sleeves attached to a taper at the base of the core implant. The introduction of tantalum with its favorable mechanical qualities markedly increased the utility and utilization of metaphyseal augments, with positive reports. These are either large augments where the bone is prepared with a burr, or later small cones placed with a cannulated broaching technique. Both have solved real problems, the first being limited by the reproducibility of bone preparation, and the second with excellent reproducibility of bone preparation but limited diameters. Other highly porous titanium surfaces have broadened the choices. Modern metaphyseal augments seek to add flexibility and options, specifically the use of offset stems. One tibial augment design features a reamed cone with a matching conical implant. Another option is based on an anatomic cone design with a single ream and a broached technique to optimise endosteal cortical bone contact. With each of these options, the augment can be placed wherever the remaining bone exists for fixation, even down to the metaphyseal-diaphyseal junction, and not limited to the area adjacent to the cut surface of bone. Once independent fixation is achieved, the intramedullary stem is cemented inside of it. Modern femoral augments are designed to sit either in the epiphyseal region, or the metaphysis. Cannulated reaming systems allow for preparation of complex asymmetrical double cone implants at the epiphysis. Metaphyseal implants are designed anatomically to sit deeper in the femoral bone, and can manage larger bony defects. Each system has benefits and compromises, and together they comprise increasingly powerful alternatives to manage extensive bone loss


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 93 - 93
1 Dec 2017
Mills R Schindeler A Little D
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Aim. Implant-associated infection remains one of the biggest challenges facing orthopaedics and there is an urgent clinical need to develop new prophylactic strategies. We have previously shown that CSA-90, a broad-spectrum antimicrobial, prevented infection in an infected open fracture model. In this study we developed a novel model of implant-associated infection, in which to further test the potential of CSA-90 as a prophylactic agent. Method. All studies were approved by the local animal ethics committee. 3D-printed porous titanium implants were implanted into the distal femora of 18 week-old male Wistar rats under general anaesthesia. The treatment groups' (n=10) implants were pre-coated with 500μg CSA-90 in saline. Staphylococcus aureus* was inoculated either directly around the implant (1×104 CFU) or injected intravenously immediately post-operatively (1×105 CFU). No systemic antibiotic prophylaxis was used. The study ran for six weeks and animals were reviewed daily for signs of infection. An independent, blinded veterinarian reviewed twice-weekly radiographs, and rats demonstrating osteolysis and/or declining overall health were culled early at their instruction. The primary outcome was implant infection, incorporating survival, microbiological, radiological, and histological measures. Results. All untreated animals inoculated with S. aureus developed clinical and radiographic evidence of implant infection and were culled within 14 days of surgery (Figure 1A). CSA-90 treatment significantly increased median survival in groups inoculated with S. aureus (p<0.001). Swab culture demonstrated that CSA-90 treated implants had a significantly reduced rate of infection compared to untreated implants in both the local (p< 0.01) and systemic (p<0.001) groups (Figure 1B). Conclusions. This study demonstrates clinical potential for CSA-90 as a novel prophylactic antimicrobial for orthopaedics. Further in vivo evaluation is required in conjunction with existing systemic antibiotic prophylaxis. Acknowledgements. This work was funded by NHMRC grant 1106982. Implants and CSA-90 were donated in kind support from Stryker and N8 Medical respectively. For any figures and tables, please contact authors directly (click on ‘Info & Metrics’ tab above for contact details)


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 34 - 34
1 Feb 2017
Bragdon C Barr C Nebergall A Rolfson O Troelsen A Rubash H Malchau H Greene M
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Introduction. In vitro studies showed that the anti-oxidative properties of vitamin E stabilize free radicals while retaining the mechanical strength of UHMWPE. The purpose was to evaluate vitamin E diffused polyethylene (VEPE) wear and stability of femoral components using RSA. Patient reported outcome measures (PROMs) were evaluated to determine the clinical outcome at 5 years. Methods. 48 patients (52 hips), with osteoarthritis, participated in a 5 year RSA study. Each patient received a VEPE liner, a porous titanium coated shell, and an uncemented stem with a 32mm head. Tantalum beads were inserted into the VEPE and the femur to measure head wear and stem stability using RSA. RSA and PROM follow-up was obtained postoperatively, 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks test determined if changes in penetration or migration were significant (p≤0.05). Results. 47 hips were followed at 3 years, and 35 at 5 years. The median± standard error (SE) superior head penetration into the polyethylene was 0.05±0.01mm at 3 years and 0.06±0.01 mm at 5 years. There was no difference after 2 years. The median± SE distal stem migration was 0.06±0.21mm at 3 years, and 0.06±0.29mm at 5 years with no significant differences over time. All PROMs improved significantly from the preoperative to all other intervals (p<0.001 for all). Discussion. The VEPE liners show low head penetration at 5 years. The early head penetration, probably due to creep, is lower relative to that reported for non-VEPE measured by RSA. While most stems were stable, the high standard error results from one stem that migrated substantially by 6 months (9.4mm), which has since stabilized. This study documents the longest-term evaluation of in vivo wear performance of vitamin E stabilized UHMWPE. The low wear and the stability of the femoral stem shows promise for long-term survivorship


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 24 - 24
1 Jan 2016
St Mart J Whittingham-Jones P Davies N Waters T
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Introduction. Bone loss in the distal femur and proximal tibia is frequently encountered with both complex primary and revision knee replacement surgery. Metaphyseal sleeves provide a good option for enhanced fixation in managing such defects on both the tibia and femur. We present our results in 48 patients (50 knees) with a minimum 12 month follow up (range 12 to 45). Methods. 48 patients (50 knees) who had revision knee arthroplasty for either septic or aseptic loosening. All were graded Type II or III using the Anderson Orthopaedic Research Institute (AORI) grading system of both femoral and tibial defects. A large portion of aseptic loosening revisions were for extreme osteolysis of a bicondylar knee prosthesis. Results. 52% had tibial sleeves only, 38% had both tibial and femoral sleeves and the remainder had only femoral sleeves inserted. All knee radiographs at final follow-up showed well-fixed osteointegrated components without component migration or clinically significant osteolysis. Two knees were treated with multiple arthroscopic washouts for infection. Two knees subsequently underwent manipulation under anaesthesia with good improvement in range of movement. One subsequently developed Complex Regional Pain Syndrome. No femoral or tibial components were revised. The average pre-operative Oxford Knee Score was 22 (12 to 38) and subsequently improved to 38 (12 to 45) post-operatively. Discussion and conclusions. Our early results show encouraging signs that porous titanium sleeves are a good option when managing large metaphyseal bone loss in both femur and tibia especially in revision arthroplasty. Post operative complications were low and functional outcome scores were comparable with more traditional knee revision arthroplasty techniques in the presence of bone loss