Introduction. Approximately 2,000 Skeletal transcutaneous osseointegration (STOI) procedures have been performed worldwide as of 2020, more than half of which have been performed by the Osseointegration Group of Australia using a press-fit technique with either ILP or OPL implant designs. Despite the consistently demonstrated clinical benefits, concerns regarding potential complications following STOI have slowed its widespread adoption. As more patients are followed for a longer period of time, longitudinal studies have confirmed complication rates are very acceptable, similar to those of total ankle and total elbow replacements. One of the major risk category is implant removal. The primary goal of this study was to investigate the complications and technical issues associated with transtibial osseointegration implant removal due to any cause. The focus here will be on the press-fit ILP and OPL implants, including the indications for removal and patient outcomes following removal. Materials & Methods. A review of our osseointegration registry between November 2010 and March 2022 was performed. Inclusion criteria were patients who have undergone removal of a transtibial osseointegration implant due to any cause. Selected patients either had a follow-up of at least two years or had their index osseointegration surgery at least two years prior to when the study was performed. Patients who have had osseointegration at other anatomic levels, and patients who underwent simultaneous total knee replacement with transtibial osseointegration were excluded from the registry search. Results. There were a total of 148 transtibial osseointegration procedures performed during the study period, with 97 (65.5%) performed in males and 51 (34.5%) performed in females. The average age at first stage osseointegration procedure is 50.4 years (range 16.8–87.9, SD 14.1). In the study cohort of 22 cases requiring implant removals, 12 (54.5%) were male and 10 (45.5%) were female. The average age at first stage osseointegration procedure in this cohort is 51.3 (range 37.4–82.6, SD 10.7) and average BMI 30.3 (range 21.9–40.9, SD 5.8). Although men comprised the majority of removals, women had a greater relative risk (Fisher exact test p=0.032). The average duration from time of STOI to removal was 2.6 years (range 0.1–6.8, SD 1.9) within this 11.5 year follow-up period. The most frequent indication was infection (54.6%, n=12) followed equally by pain (13.6%, n=3), aseptic loosening (13.6%, n=3) and implant fracture (13.6%, n=3), and lastly failure to integrate (4.6%, n=1). Conclusions. Of the 22 removals, 12 were reimplanted at the same anatomical level (10 were reimplanted within 6 months, 1 within 12 months, and 1 within 24 months). 11 of these cases currently wear their prosthetic legs for more than 13 hours daily. 1 case was recently reimplanted and still completing their loading program. Of the patients who were not reimplanted at the same anatomical level, 1 required proximal amputation with transfemoral osseointegration. 3 patients converted to traditional socket prostheses (TSP) due to pain, and 1 underwent proximal amputation and converted to TSP due to infection. 3 cases are currently awaiting transtibial osseointegration reimplantation, and 1 patient was deceased. 1 patient was lost to follow-up

Introduction. Percutaneous EndoProsthetic Osseointegration for Limbs (PEPOL) facilitates improved quality of life (QOL) and objective mobility for most amputees discontent with their traditional socket prosthesis (TSP) experience. Some amputees desiring PEPOL have residual bone much shorter than the currently marketed press-fit implant lengths of 14–16 cm, potentially a risk for failure to integrate. We report on the techniques used, complications experienced, the management of those complications, and the overall mobility outcomes of seven patients who had femur distraction osteogenesis (DO) with a Freedom nail followed by PEPOL. Materials & Methods. Retrospective evaluation of a prospectively maintained database identified nine patients (5 females) who had transfemoral DO in preparation for PEPOL with two years of follow-up after PEPOL. Six patients had traumatic causes of amputation, one had perinatal complications, one was performed to manage necrotizing fasciitis and one was performed as a result of osteosarcoma. Results. The average age at which DO commenced was 39.4±15.9 years, and seven patients had their amputation more than ten years prior (average 25.5±18.8 years). The residual femurs on average started at 102.2±39.7 mm and were lengthened 58.1±20.7 mm, 98±45% of goal (99±161% of the original bone length). Five patients (56%) had a complication requiring additional surgery: four events of inadequate regenerate were managed with continued lengthening to desired goal followed by autograft placement harvested from contralateral femur reaming; one patient had the cerclage wires break which required operative replacement. All patients had osseointegration performed, at 355±123 days after the initial lengthening nail surgery. One patient had K-level >2 before DO, at a mean of 3.4±0.6 (2.6–4.4) years following osseointegration six patients had K-level >2. The 6 Minute Walk Test remained unchanged (267±56 vs 308 ± 117 meters). Patient self-rating of prosthesis function, problems, and amputee situation did not significantly change from before DO to after osseointegration. Six patients required additional surgery following osseointegration: six to remove fixation plates placed to maintain distraction osteogenesis length at osseointegration; two required irritation and debridement for infection. Conclusions. Extremely short residual femurs which make TSP use troublesome can be lengthening with externally controlled telescoping nails, and successfully achieve osseointegration. However, it is imperative to counsel patients that additional surgery to address inadequate regenerate or to remove painful hardware used to maintain fixation may be necessary. This may improve the amputee's expectations before beginning on a potentially arduous process

Percutaneous EndoProsthetic Osseointegration for Limbs (PEPOL) facilitates improved quality of life (QOL) and objective mobility for most amputee's discontent with their traditional socket prosthesis (TSP) experience. Some amputees desiring PEPOL have residual bone much shorter than the currently marketed press-fit implant lengths of 14-16 cm, potentially a risk for failure to integrate. We report on the techniques used, complications experienced, the management of those complications, and the overall mobility outcomes of seven patients who had femur distraction osteogenesis (DO) with a Freedom nail followed by PEPOL. Retrospective evaluation of a prospectively maintained database identified nine patients (5 females) who had transfemoral DO in preparation for PEPOL with two years of follow-up after PEPOL. Six patients had traumatic causes of amputation, one had perinatal complications, one was performed to manage necrotizing fasciitis and one was performed as a result of osteosarcoma. The residual femurs on average started at 102.2±39.7 mm and were lengthened 58.1±20.7 mm, 98±45% of goal (99±161% of the original bone length). Five patients (56%) had a complication requiring additional surgery. At a mean of 3.4±0.6 (2.6-4.4) years following osseointegration six patients had K-level >2. The 6 Minute Walk Test remained unchanged (267±56 vs 308 ± 117 meters). Patient self-rating of prosthesis function, problems, and amputee situation did not significantly change from before DO to after osseointegration. Six patients required additional surgery following osseointegration: six to remove fixation plates placed to maintain distraction osteogenesis length at osseointegration; two required irritation and debridement for infection. Extremely short residual femurs which make TSP use troublesome can be lengthening with externally controlled telescoping nails, and successfully achieve osseointegration. However, it is imperative to counsel patients that additional surgery to address inadequate regenerate or to remove painful hardware used to maintain fixation may be necessary. This may improve the amputee's expectations before beginning on a potentially arduous process

Introduction. Transtibial osseointegration (TFOI) for amputees has limited but clear literature identifying superior quality of life and mobility versus a socketed prosthesis. Some amputees have knee arthritis that would be relieved by a total knee replacement (TKR). No other group has reported performing a TKR in association with TTOI (TKR+TTOI). We report the outcomes of nine patients who had TKR+TTOI, followed for an average 6.5 years. Materials & Methods. Our osseointegration registry was retrospectively reviewed to identify all patients who had TTOI and who also had TKR, performed at least two years prior. Four patients had TKR first the TTOI, four patients had simultaneous TKR+TTOI, and one patient had 1 OI first then TKR. All constructs were in continuity from hinged TKR to the prosthetic limb. Outcomes were: complications prompting surgical intervention, and changes in daily prosthesis wear hours, Questionnaire for Persons with a Transfemoral Amputation (QTFA), and Short Form 36 (SF36). All patients had clinical follow-up, but two patients did not have complete survey and mobility tests at both time periods. Results. Six (67%) were male, average age 51.2±14.7 years. All primary amputations were performed to manage traumatic injury or its sequelae. No patients died. Five patients (56%) developed infection leading to eventual transfemoral amputation 36.0±15.3 months later, and 1 patient had a single debridement six years after TTOI with no additional surgery in the subsequent two years. All patients who had transfemoral amputation elected for and received transfemoral osseointegration, and no infections occurred, although one patient sustained a periprosthetic fracture which was managed with internal fixation and implant retention and walks independently. The proportion of patients who wore their prosthesis at least 8 hours daily was 5/9=56%, versus 7/9=78% (p=.620). Even after proximal level amputation, the QTFA scores improved versus prior to TKR+TTOI, although not significantly: Global (45.2±20.3 vs 66.7±27.6, p=.179), Problem (39.8±19.8 vs 21.5±16.8, p=.205), Mobility (54.8±28.1 vs 67.7±25.0, p=.356). SF36 changes were also non-significant: Mental (58.6±7.0 vs 46.1±11.0, p=.068), Physical (34.3±6.1 vs 35.2±13.7, p=.904). Conclusions. TKR+TTOI presents a high risk for eventual infection prompting subsequent transfemoral amputation. Although none of these patients died, in general, TKR infection can lead to patient mortality. Given the exceptional benefit to preserving the knee joint to preserve amputee mobility and quality of life, it would be devastating to flatly force transtibial amputees with severe degenerative knee joint pain and unable to use a socket prosthesis to choose between TTOI but a painful knee, or preemptive transfemoral amputation for transfemoral osseointegration. Therefore, TTOI for patients who also request TKR must be considered cautiously. Given that this frequency of infection does not occur in patients who have total hip replacement in association with transfemoral osseointegration, the underlying issue may not be that linked joint replacement with osseointegrated limb replacement is incompatible, but may require further consideration of biological barriers to ascending infection and/or significant changes to implant design, surgical technique, or other yet-uncertain factors

Traditional socket prosthesis (TSP) rehabilitation for amputees is associated with substantial dissatisfaction due to poor mobility and pain from soft tissue squeezing. Osseointegration (OI), eliminates skin compression and prosthesis fit issues, providing superior mobility and quality of life (QOL) for most amputees. The potential for OI to benefit patients with exceptionally poor mobility is understudied. To address this knowledge gap, this project investigated the mobility and QOL changes. A retrospective review was performed to identify transfemoral amputees who presented with wheelchair-bound mobility (K0) and had at least five years of post-osseointegration follow-up. Outcome measures included changes in mobility (K-level, daily prosthesis wear hours, Timed Up and Go (TUG), 6 minute walk test (6MWT)) and QOL (Questionnaire for persons with a Transfemoral Amputation (QTFA); Short Form Health Survey 36 (SF36). Adverse events recorded included debridement for infection, implant revision surgery, fractures, and implant failures. 9 patients with mean age 48.2±7.7 (range 34-59) years were included. The proportion of patients achieving K-level >2 improved from 0/9=0% to [9/9=100%], p<0.001. The 6MWT improved from 0±0 to 320.65±57 meters (p<0.001). The TUG improved from incapable to 10.68±2.7 seconds (p<0.001). Statistically significant QOL metrics included QTFA global score (33.33±31 vs 68.52±21, p=0.039), SF36 physical component score (30.03±6.3 vs 42.34±12, p=0.023) and the SF36 mental component score (47.89±8.8 vs 51.95±10.4, p=0.332). Six patients required operative intervention to address complications. Five developed infections: three had debridement, and 2 required implant removal and reimplantation. Osseointegration does confer significant sustained mobility and quality of life improvement for wheelchair bound transfemoral amputees. All 9 K0 patients had statistically improved mobility and QOL after osseointegrated reconstruction. This supports osseointegration as an effective rapid and long-term rehabilitation alternative for patients who have the neurologic and muscular capacity to walk but are unable due to issues related to their TSP

Introduction. The use of osseointegrated limb replacement prostheses for amputees are rapidly growing in popularity due to the many benefits over conventional sockets. Many institutions worldwide are beginning to provide this surgical option to their patients and are advertising the service online. The aim of this study was to assess the quality and reading level of related information available online. Materials & Methods. A search was performed using the 3 most popular English language search engines reviewing the top 40 websites from each, using the term osseointegration on. Duplicates, videos, medical journal articles and dentistry websites were excluded. All included websites were assessed for reading using the FKGL, G-Fog and FRE. Quality was assessed using the JAMA benchmark criteria, HONC erificate and a novel 16-point scoring system developed specifically for limb replacement osseointegration. Results. The search resulted in 9,985,000 websites, 120 were assessed. 23 websites were included after removal of duplicates, medical journals and dentistry websites. None with reading grades of 6 or lower. Mean FKGL grade was 11.3/18. Mean FRE was 38.83/100. Mean G-FOG was 12.57/20. No websites had HONC. Mean JAMA score was 1.76/4. Mean HSSOIS was 5.70/16. Most provided information on indications(16/23) and explanation of osseointegration 17/23) but few discussed costs(3/23) or restrictions(9/23). Conclusions. There is already a large amount of information available online regarding osseointegrated prostheses. However, the most accessible information may exceed most patients’ reading levels, limiting is usefulness. Further, the information available is generally of low quality, The quality of information and the readability of online content should be improved to ensure more effective patient education

Introduction. Transfemoral osseointegration (TFOI) for amputees has substantial literature proving superior quality of life and mobility versus a socketed prosthesis. Some amputees have hip arthritis that would be relieved by a total hip replacement (THR). No other group has reported performing a THR in association with TFOI (THR+TFOI). We report the outcomes of eight patients who had THR+TFOI, followed for an average 5.2 years. Materials & Methods. Our osseointegration registry was retrospectively reviewed to identify all patients who had TFOI and also had THR, performed at least two years prior. Six patients had TFOI then THR, one simultaneous, one THR then TFOI. All constructs were in continuity from hip to prosthetic limb. Outcomes were: complications prompting surgical intervention, and changes in subjective hip pain, K-level, daily prosthesis wear hours, Questionnaire for Persons with a Transfemoral Amputation (QTFA), and Short Form 36 (SF36). All patients had clinical follow-up, but one patient did not have complete mobility and quality of life survey data at both time periods. Results. Four (50%) were male, average age 52.7±14.8 years. Three patients (38%) had amputation for trauma, three for osteosarcoma, one each (13%) infected total knee and persistent infection after deformity surgery. One patient died one year after THR+TOFA from subsequently diagnosed pancreatic cancer. One patient had superficial debridement for infection with implant retention after five years. No implants were removed, no fractures occurred. All patients reported severe hip pain preoperatively versus full relief of hip pain afterwards. K-level improved from 0/8=0% K>2 (six were wheelchair-bound) to 5/8=63% (p=.026). At least 8 hours of prosthesis wear was reported by 2/7=29% before TOFA vs 5/7=71% after (p=.286). The QTFA improved in all categories, but not significantly: Global (40.0±21.6 vs 60.0±10.9, p=.136), Problem (50.2±33.2 vs 15.4±8.4, p=.079), and Mobility (35.9±26.8 vs 58.3±30.7, p=.150). The SF36 also improved minimally and not significantly: Mental (53.6±12.0 vs 54.7±4.6, p=.849) and Physical (32.5±10.9 vs 36.3±11.2, p=.634). Conclusions. THR+TFOI is a successful reconstruction option for amputees who desire relief from severe pain related to hip joint degeneration, and also the opportunity for improved mobility and quality of life that TFOI typically confers. In our cohort, the procedure proved safe: no associated deaths, no removals, one soft tissue debridement. Mobility improved markedly. Quality of life improved, but not to significant thresholds as measured by the surveys. THR+TFOI appears safe and reasonable to offer to transfemoral amputees with painful hip joint degeneration

Due to unsatisfactory results and reported drawbacks of anterior cruciate ligament (ACL) reconstruction new regenerative approaches based on tissue-engineering strategies are currently under investigation. It was the purpose of this study to determine if a novel silk fiber-based ACL scaffold is able to initiate osteointegration in the femoral and tibial bone tunnels under in vivo conditions. Furthermore we tested if the osteointegration process will be improved by intraoperatively seeding the scaffolds with the autologous stromal vascular fraction, an adipose-derived, stem cell-rich isolate from knee fat pads. In this controlled laboratory study, 33 sheep underwent ACL resection and were then randomly assigned to 2 experimental groups: ACL reconstruction with a scaffold alone and ACL reconstruction with a cell-seeded scaffold. Half of the sheep in each group were randomly chosen and euthanized 6 months after surgery and the other half at 12 months. To analyze the integration of the silk-based scaffold in the femoral and tibial bone tunnels, hard tissue histology and micro-computed tomography measurements were performed. The histological workup showed that in all treatment groups, with or without the application of the autologous stromal vascular fraction, an interzone of collagen fibers had formed between bone and silk-based graft. This collagen-fiber continuity partly consisted of Sharpey fibers, comparable with tendon-bone healing known for autografts and allografts. Insertion sites were more broad based at 6 months and more concentrated on the slightly protruding, bony knoblike structures at 12 months. Histologically, no differences between the treatment groups were detectable. Analysis of micro-computed tomography measurements revealed a significantly higher tissue density for the cell-seeded scaffold group as compared with the scaffold-alone group in the tibial but not femoral bone tunnel after 12 months of implantation. The novel silk fiber-based scaffold for ACL regeneration demonstrated integration into the bone tunnels via the formation of a fibrous interzone similar to allografts and autografts. Histologically, additional cell seeding did not enhance osteointegration. No significant differences between 6 and 12 months could be detected. After 12 months, there was still a considerable amount of silk present, and a longer observation period is necessary to see if a true ligament-bone enthesis will be formed

Surgical failure, mainly caused by loosening implants, causes great mental and physical trauma to patients. Improving the physicochemical properties of implants to achieve favourable osseointegration will continue to be the focus of future research. Strontium (Sr), a trace element, is often incorporated into hydroxyapatite (HA) to improve its osteogenic activity. Our previous studies have shown that miR-21 can promote the osteogenic differentiation of mesenchymal stem cells by the PI3K/β-catenin pathway. The aim of this study is to fabricate a SrHA and miR-21 composite coating and it is expected to have a favorable bone healing capability. Ti discs (20 mm diameter and one mm thickness for the in vitro section) and rods (four mm diameter and seven mm length for the in vivo section) were prepared by machining pure Ti. The Ti cylinders were placed in a Teflon-lined stainless-steel autoclave for treating at 150°C for 24 h to form SrHA layer. The miR-21 was encapsulated in nanocapsules. The miR-21 nanocapsules were mixed with CMCS powder to form a gel-like sample and uniformly coated on the SrHA modifed Ti. Osteoblast-like MG63 cells were cultured on SrHA and miR-21 modified Ti, Cell proliferation activity and osteogenesis-related gene expression were evaluated. A bone defect model was established with mature New Zealand to evaluate the osseointegration. Cylindrical holes (four mm in diameter) were created at the distal femur and tibial plateau. Each rabbit was implanted with four of the aforementioned rods (distal femur and tibial plateau of the hind legs). After implantation for one, two and three months, the rabbits were observed by X-ray and scanned using u-CT. Histological and Immunohistochemical analysis were performed to examine the osteogenic markers. A biomechanical push-in test was used to assess the bone-implant bonding strength. Both SrHA nanoparticles with good superhydrophilicity and miR-21 nanocapsules with uniform sizes were distributed evenly on the surface of the Ti. In vitro experiments revealed that the composite coating was beneficial to osteoblast proliferation, differentiation and mineralization. In vivo evaluations demonstrated that this coating could not only promote the expression of angiogenic factor CD31 but also enhance the expression of osteoblastic genes to facilitate angio-osteogenesis. In addition, the composite coating also showed a decreased RANKL expression compared with the miR-21 coating. As a result, the SrHA/miR-21 composite coating promoted new bone formation and mineralization and thus enhanced osseointegration and bone-implant bonding strength. A homogeneous SrHA and miR-21 composite coating was fabricated by generating pure Ti through a hydrothermal process, followed by adhering miR-21 nanocapsules. This coating combined the favorable physicochemical properties of SrHA and miR-21 that synergistically promoted angiogenesis, osteogenesis, osseointegration, bone mineralization and thus bone-implant bonding strength. This study provided a new strategy for surface modification of biomedical implants

Proximal femoral focal deficiency is a congenital disorder of malformation of the proximal femur and/or the acetabulum. Patients present with limb length discrepancy and clinical features along a spectrum of severity. As these patients progress through to skeletal maturity and on to adulthood, altered biomechanical demands lead to progression of arthropathy in any joint within the lower limb. Abnormal anatomy presents a challenge to surgeons and conventional approaches and implants may not necessarily be applicable. We present a case of a 62-year-old lady with unilateral proximal femoral focal deficiency (suspected Aitken Class A) who ambulated with an equinus prosthesis for her entire life. She presented with ipsilateral knee pain and instability due to knee arthritis but could not tolerate a total knee arthroplasty due to poor quadriceps control. A custom osteointegration prosthesis was inserted with a view to converting to the proximal segment to a total hip replacement if required. The patient went on to develop ipsilateral symptomatic hip arthritis but altered acetabular anatomy required a custom tri-flange component (Ossis, Christchurch, New Zealand) and a custom proximal femoral component to link with the existing osseointegration component (Osseointegration Group of Australia, Sydney, Australia) were designed and implanted. The 18 month follow up of the custom hip components showed that the patient had Oxford hip scores that were markedly improved from pre-operatively. Knee joint heights were successfully restored to equal when the patient's prosthesis was attached. The patient describes feeling like “a normal person”, walks unaided for short distances and can ambulate longer distances with crutches. Advances in design and manufacture of implants have empowered surgeons to offer life improving treatments to patients with challenging anatomy. Using a custom acetabular tri-flange and osseointegration components is one possible solution to address symptomatic ipsilateral hip and knee arthropathy in the context of PFFD in adulthood

Introduction:. Non-cemented, porous-coated metaphyseal sleeves have been designed to improve biologic fixation and stability in revision total knee arthroplasty (TKA) with major bone defects. The aim of this study was to evaluate the clinical results and osteointegration of these sleeves in major bone loss. Materials and Methods:. Between 2008 and 2011, 24 revision TKAs with major bone loss were reconstructed with non-cemented, porous-coated proximal sleeve (DePuy, Warsaw, IN). All patients were prospectively followed for a minimum of 2 years. Indications for use of sleeves were major metaphyseal tibial and femoral bone loss, younger age, and higher activity level. Osteointegration around the sleeves were classified as: . –. Grade 1: Complete osteointegration in all views without any demarcation. –. Grade 2: Sleeves that are not completely osteointegrated but they are stable. Grade 2A: Demarcation less than 2 mm on any view. Grade 2B: Demarcation more than 2 mm on any view . –. Grade 3: Sleeves that are not osteointegrated and unstable with evidence of subsidence. Grade 3A: Subsidence less than 2 mm on any view. Grade 3B: Subsidence more than 2 mm on any view. Results:. Mean range of motion and Knee Society Scores were 108 degrees and 92 respectively. 14 cases were revised for aseptic loosening and 10 cases for infection (which were treated with two stage revision arthroplasty). There was no malalignment, subsidence or re-revision at final follow-up. All sleeves were osteointegrated with majority grade 1 or 2a. Discussion and conclusion:. Short-term results of non-cemented metaphyseal sleeves in major bone loss for loosening of infection demonstrated excellent clinical results and osteointegration

Aseptic loosening is the most common cause of failure in load bearing orthopaedic implants. This is most often attributed to stress shielding, which is caused by a mismatch in mechanical properties between the implant and bone, predominantly stiffness. The implant causes a redistribution of the forces through the bone leading to localised tissue resorption in low stress areas and over time loosening of the implant. To address this, the implant design may be modified to introduce porous structures that reduced overall stiffness. Conventional methods of creating porous structures include the space holder method and gas foaming, although these allow control of the pore size and volume fraction, the position of the voids is random and potentially non-uniform, creating unpredictable mechanical properties. Using additive manufacture predictable porous lattice structures can be built. Two methods for creating lattice structure are explored here: controlled stochastic lattices, and layers of repeating unit cells. Due to the predictable nature of these design methods the mechanical properties can be tailored to suit the needs of the implants. In addition to mechanical optimisation the porous lattice structures can be optimised for osseointegration properties. The ability of the tissue to grow into the implant are affected by; the size of the pores, how interconnected the pores are, the overall void fraction (porosity), the shape and roughness of the pores, and whether the structure is coated. Although additive manufacture allows great design freedoms, there are also some manufacturing constraints to consider including resolution which is determined by powder and laser spot size, and strut angle since these cannot be too close to horizontal or they will collapse during the build unless supported. This preliminary work uses Finite Element Analysis to model the compressive properties of lattice structures with different design parameters, with the intention to optimise for mechanical, osseointegration and manufacturability properties. Cylinders of the lattice structures were generated in Simpleware ScanIP (Synopsys, Exeter, UK) and their compression was modelled in Ansys Workbench 18.2 (Canonsburg, PA, USA) in accordance with ISO 13314. Stress distributions for each lattice structure were produced which showed the stochastic lattice did not undergo banded deformation unlike the repeating unit cell based lattices. Future work will physically test the lattices and feed that data back into the model for further optimisation. Other relevant mechanical testing will be modelled and performed in order to choose the optimal lattice design for future implants

Introduction. Extensive bone loss and poor residual bone quality can make implant fixation difficult to achieve in revision of failed megaprostheses. While newer porous components are available to address various periarticular cavitary and segmental defects, diaphyseal fixation remains challenging without resorting to cemented techniques, or cementless fully-coated stems that achieve fixation over long segments of bone. In cases of previous infection, it may be advantageous to avoid the use of such devices as they can be difficult to remove and may result in even greater bone loss if the infection were to persist. Compressive osseointegration technology has been become a valuable device in the management of these challenging situations. Objectives. We aimed to evaluate the short-term results of compressive osseointegration when used for reconstruction of massive diaphyseal and segmental bone defects. We believe that compressive osseointegration provides predictable, strong endoprosthesis fixation in the short-term and that osseointegration can be evaluated radiogrphically. Methods. We retrospectively reviewed a total of 32 implants (spindles) in 28 patients with failed prior megaprosthetic reconstructions. Procedures were performed at two institutions by six surgeons. Data recorded included patient demographics, indication for surgery, diaphyseal segment and joint reconstructed, and any complications. Results. Average patient age and body mass index at time of surgery were 48 years (range 14–68) and 28.1 m2 (range 17–58), respectively. Indications included aseptic loosening (18), loosening and infection (11), and allograft-prosthetic composite nonunion (3). The reconstructions consisted of distal femoral replacement (16), proximal femoral replacement (10), distal humeral replacement (4) and proximal ulnar replacement (2). There were five spindle failures in 4 patients. Three were converted to a Compress device, two were successful one converted to a cemented stem and another patient was also converted to a cemented stem. Other complications that required repeat surgery included hinge failure (2), arthrofibrosis (1), segment taper adapter fracture (2), persistent chronic deep wound infection (1)and superficial wound infection (1). Fixation at the bone-implant interface remained intact in each of these cases. There was 1 deep infection in this series in spite of a large number of index infected megaprostheses. Twenty-six of twenty-eight patients (92.8%) achieved stable osteointegration and we had an overall spindle osteointegration failure rate of 15.6% (5 of 32) at a mean follow-up length of 16.7 months (range 0.5–57.4). The cortex/spindle ratio of these increased from 0.33 (SD 0.9) immediately postoperatively to 0.53 (SD 0.15) at final follow-up (p < 0.001). At most recent follow-up, these patients reported satisfaction and painless function of the operative limb. Conclusion. Use of compressive osseointegration for revision of failed massive segmental bone defects (See Fig 1 and 2) provides reliable short term fixation, and may prove to be bone conserving in cases that require future re-revision. The cortex/spindle ratio reliably increases over time as fixation is achieved. It has become our device of choice for failed limb salvage reconstructions

Few studies have been reported focusing on developing implant surface nanofiber (NF) coating to prevent infection and enhance osseointegration by local drug release. In this study, coaxial doxycycline (Doxy)-doped polycaprolactone/polyvinyl alcohol (PCL/PVA) NFs were directly deposited on the titanium (Ti) implant surface during electrospinning. The bonding strength of Doxy-doped NF coating on Ti implants was confirmed by a stand single-pass scratch test. The improved implant osseointegration by PCL/PVA NF coatings in vivo was confirmed by scanning electron microscopy, histomorphometry and micro computed tomography at 2, 4 and 8 weeks after implantation. The bone contact surface (%) changes of NF coating group (80%) is significantly higher than that of no NF group (< 5%, p<0.05). Finally, we demonstrated that Doxy-doped NF coating effectively inhibited bacterial infection and enhanced osseointegration in an infected (Staphylococcus aureus) tibia implantation rat model. Doxy released from NF coating inhibited bacterial growth up to 8 weeks in vivo. The maximal push-in force of Doxy-NF coating (38 N) is much higher than that of NF coating group (6.5 N) 8 weeks after implantation (p<0.05), which was further confirmed by quantitative histological analysis and micro computed tomography. These findings indicate that coaxial PCL/PVA NF coating doped with Doxy and/or other drugs have great potential in enhancing implant osseointegration and preventing infection

Silicon nitride spinal fusion cages have been successfully used in the treatment or correction of stenosis, disc herniation, trauma, and other deformities of the spinal column since 2008. To date over 14,000 devices have been implanted with perioperative and postoperative complication rates of less than 0.2%. This remarkable achievement is due in part to the material itself. Silicon nitride is an ideal interbody material, possessing high strength and fracture toughness, inherent phase stability, biocompatibility, hydrophilicity, excellent radiographic imaging, and bacterial resistance. These characteristics can lead to implants that aid in prevention of nosocomial infections and achieve rapid osteointegration. In this paper, we will review the various in vitro and in vivo studies that demonstrate silicon nitride's effective bacteriostatic and osteointegration characteristics, and compare these to the two most common cage materials – titanium and poly-ether-ether-ketone (PEEK). Human case studies will be also reviewed to contrast the clinical performance of these biomaterials. In comparison to the traditional devices, silicon nitride shows lower infection rates, higher bone apposition, and essentially no fibrous tissue growth on or around the implant. To better understand the mechanisms underlying these benefits, surface characterization studies using scanning electron microscopy coupled with XPS chemical analyses, sessile water drop techniques and streaming zeta potential measurements will be reported. Data from these studies will be discussed in relation to the physiochemical reasons for the observed behavior. Silicon nitride is a non-oxide ceramic in its bulk; but possesses a protective Si-N-O transitional layer at its surface. It will be shown that the chemistry and morphology of this layer can be modified in composition, thickness and structure resulting in marked changes in chemical species, surface charge, isoelectric points and wetting behavior. It is postulated that the needle-like grain structure of silicon nitride coupled with its enhanced wettability play important roles in inhibiting biofilm formation, while its surface chemical environment consisting of silicon diimide Si(NH). 2. , silicic acid Si(OH). 4. , and derivatives of ammonia, NH. 3. , NH. 4. OH, lead to improved bone reformation and bacteriostasis, respectively. Few materials have this combination of properties, making silicon nitride a unique biomaterial that provides improved patient care and outcomes with low comorbidities

Introduction. The following study start from an idea of the evaluation of the osteointegration in the bone cage of the Equinoxe Reverse shoulder prosthesis. The aim of the study is to assess the values of Bone Mineral Density (BMD) in periprosthetic areas, in patients undergoing shoulder arthroplasty with implants of the Equinoxe system by Excatech, Inc. To better understand the steps of osteointegration time of the bone cage with the glenoid. The objectives of the work are not only expanded to the value of osteointegration, but could also be useful for the evaluation of both mechanical and septic loosening of the stem of the glenoid. Materials and Methods. In the period from November 2011 to May 2012, 15 patients were evaluated. All patients were subjected to bone densitometry type of DXA within the first 15 days after surgery and at 3 months after surgery. The patients are all part of a homogeneous group for anatomical glenoid. Were excluded from the study all patients who were no significant alterations of the head and the glenoid. The acquisitions were performed with the patient in an oblique position, with limb in a neutral position, in order to obtain images in the coronal plane “true” of the joint. Were subsequently calculated values of BMD is around the stem with the 7 areas used by Gruen for the hip prosthesis and peripherally to the central peg using 3 areas, superiorly, medially and inferiorly to the same. Results. The values obtained showed a significant increase in the time of bone density peripherally to the central peg demonstrating a significant osteointegration. Being a prospective study these values will be integrated with new acquisition DXA to 6, 9, 12 months, 2, 3 and 5 years. Conclusions. Although preliminary, through our study it was possible to obtain the standard values of BMD in patients with prosthetic replacement has been successful. These BMD values represent a standard of reference for the physiological osseointegration; in the future must be evaluated for their variation in patients with prosthetic loosening and / or with infectious processes, in order to allow an early diagnosis of these diseases by studying DXA. Also in future studies BMD values obtained by us of the Equinoxe prosthesis can be compared with those obtained in other models of the shoulder prosthesis to detect any advantages or disadvantages in terms of osteointegration

Introduction. Trabecular Titanium™ is a highly porous biomaterial with a regular hexagonal cell structure, which has shown excellent mechanical properties. Several in vitro studies reported promising data on its osteoinductive and osteoconductive properties. Furthermore, it has demonstrated in vivo to enhance bone in-growth. Aim of this multicentre prospective study was to assess Trabecular Titanium™ osseointegration by measuring change in bone mineral density (BMD) around a cementless DELTA-TT cup with dual-emission X-ray absorptiometry (DXA). Methods. 89 patients (91 hips) underwent primary THA with DELTA-TT cups (Lima Corporate) between 2009 and 2010. There were 46 (52%) men and 43 (48%) women, with a median (IQR) age of 67 (57–70) years and a median (IQR) BMI of 26 (24–29) kg/m. 2. Right side and left side were affected in 44 (48%) and 47 (52%) cases, respectively. Underlying pathology was primary osteoarthritis in 80 (88%) cases, osteonecrosis in 5 (6%), post-traumatic osteoarthritis in 3 (3%), developmental dysplasia of the hip in 2 (2%) and oligoarthritis in 1 (1%). BMD was determined by DXA using DeLee and Charnley 3 Regions of Interest (ROI) at 7 days, 3, 6, 12 and 24 months. Clinical evaluation (Harris Hip Score, HHS), patient health status survey (SF-36) and radiographic assessment were performed preoperatively and at the same time-points. Data were analyzed using non-parametric tests (Mann-Whitney, Wilcoxon signed-rank) and a p < 0.05 as threshold for statistical significance. Results. Excellent results were observed in terms of pain relief and functional recovery. Median (IQR) HHS improved from 48 (39–62) before surgery, to 99 (96–100) at 24 months, with a statistical significant increase of 96% (p < 0.05, Wilcoxon signed-rank). Median (IQR) SF-36 improved from 49 (37–62) preoperatively to 86 (79–92) at 24 months, with a statistical significant increase of 95% (p < 0.05, Wilcoxon signed-rank), indicating a considerable improvement in patients' quality of life. After an initial decrease of BMD values from baseline at 7 days (median [IQR] ROI I: 1.44 [1.21–1.67]; ROI II: 1.23 [0.99–1.49]; ROI III: 1.11 [0.85–1.48] g/cm. 2. ) to 6 months (ROI I: 1.27 [1.08–1.52]; ROI II: 1.14 [0.89–1.37]; ROI III: 1.05 [0.73–1.35] g/cm. 2. ), BMD slightly increased in ROI I, the most loaded area, and stabilized in ROI III. BMD in ROI II increased after 12 months and stabilized at 24 months (ROI I: 1.30 [1.11–1.55]; ROI II: 1.12 [0.96–1.36]; ROI III: 1.04 [0.80–1.25] g/cm. 2. ). Radiographic analysis showed evident signs of bone remodeling and osseointegration, with presence of supero-lateral and infero-medial bone buttress and of radial trabeculae perpendicular to the cup surface in ROI I/II. No radiolucent lines, loosening or osteolysis were observed. All cups were stable and no revision was carried out. Conclusion. BMD patterns and radiographic evaluation showed signs of an effective osseointegration around DELTA-TT cups at 24 months. Although clinical outcomes, functional recovery and stability are very satisfactory, longer follow-ups are necessary to assess survivorship

Purpose. To review prospectively collected data on patients undergoing primary total hip arthroplasty utilizing two different cementless acetabular components. Materials & Methods. All patients undergoing primary total hip replacement surgery at our institution are entered prospectively into a database which includes history and physical examination, radiology, WOMAC and SF-36 scores. The patients are re-examined, re-x-rayed and re-scored at 3 months, 6 months and 1 year after surgery and yearly thereafter. Using this database we are able to identify patients who have undergone total hip replacement using one of two geometric variants of the acetabular component. The first design is hemispherical and the second design has a peripheral rim expansion designed to increase initial press-fit stability. Results. Five hundred and twenty-seven consecutive primary total hip replacements were identified using either of the geometric variants of the acetabular component. Results at a mean of 7 years revealed a 95.6% survivorship with no significant difference between the two component designs with revision for aseptic loosening as the end point. Functional scores between the two groups of patients also demonstrated no statistically significant difference. Radiologic assessment, however, showed a difference between the two designs. The hemispherical design which matches the reamer line-to-line had 80% complete osseointegration on final radiologic review while the second design with a peripheral rim expansion had only 57% complete osseointegration. This was statistically significant. The peripherally expanded components also had a greater number of screws inserted at the time of surgery, felt by us to be a reflection of initial surgeon dissatisfaction with component stability at the time of insertion of the component

INTRODUCTION. Trabecular Titanium™ is an innovative material characterised by an high open porosity and composed by multi-planar regular hexagonal cells. It is not a traditional coating and its tri-dimensional structure has been studied to optimise osteointegration. Furthermore, it has excellent mechanical properties, as a very high tensile and fatigue resistance and an elastic module very similar to the that of the trabecular bone. The aim of this study is to evaluate the osteointegration and bone remodelling measuring the longitudinal pattern of change in BMD around a cementless acetabular cup made from Trabecular Titanium™ (Delta TT cup, Lima Corporate, Italy) in primary total hip arthroplasty (THA). METHODS. Dual-energy x-ray absorptiometry (DEXA) analysis, radiographic evaluation on standard AP and lateral views and clinical evaluation with Harris Hip Score (HHS) and SF-36 were performed at 1 week, 3, 6, 12 months after surgery. RESULTS. Between February 2009 and June 2010, 72 patients underwent primary THA with Delta TT cup at 4 centres. There were 36 (50%) female and 36 (50%) male with an average age of 63 (range 39-75). Preliminary results include 72 patients with 56 at 3 months, 42 at 6 months and 28 at 12 months. The mean HHS improved from 48 points (range 14-79) preoperatively to 88 (range 74-100) at 3 months, to 94 (range 71-100) at 6 months and to 97 (range 94-100) at 12 months. SF-36 reported a progressive improvement of all domains. An initial transient decrease of the bone mineral density (BMD) occurred between 1 week and 3 months after surgery, then bone mass returns to baseline values after 6 months and increased at 12 months. No radiolucent lines nor osteolysis have reported and no revision occurred. There were 2 complications not related to the implant on study: one dislocation solved with a close reduction and one dislocation solved with a revision of the neck and the head, but not compromising the cup. CONCLUSIONS. Delta TT acetabular cup allows to obtain a very good primary stability, thanks to the high friction coefficient of the Trabecular Titanium™, followed by a good and fast osteointegration, as reported by early DEXA outcomes. Preliminary results showed also a very good clinical and functional improvement. Long-term follow-up is ongoing in order to prove these promising results

To review prospectively collected data on patients undergoing primary total hip arthroplasty utilizing two different cementless acetabular components. All patients undergoing primary total hip replacement surgery at our institution are entered prospectively into a database which includes history and physical examination, radiology, WOMAC and SF-36 scores. The patients are re-examined, re-x-rayed and re-scored at 3 months, 6 months and 1 year after surgery and yearly thereafter. Using this database we are able to identify patients who have undergone total hip replacement using one of two geometric variants of the acetabular component. The first design is hemispherical and the second design has a peripheral rim expansion designed to increase initial press-fit stability. Five hundred and twenty-seven consecutive primary total hip replacements were identified using either of the geometric variants of the acetabular component. Results at a mean of 7 years revealed a 95.6% survivorship with no significant difference between the two component designs with revision for aseptic loosening as the end point. Functional scores between the two groups of patients also demonstrated no statistically significant difference. Radiologic assessment, however, showed a difference between the two designs. The hemispherical design which matches the reamer line-to-line had 80% complete osseointegration on final radiologic review while the second design with a peripheral rim expansion had only 57% complete osseointegration. This was statistically significant. The peripherally expanded components also had a greater number of screws inserted at the time of surgery, felt by us to be a reflection of initial surgeon dissatisfaction with component stability at the time of insertion of the component. The difference in screw numbers was also statistically significant. This study demonstrates that a hemispherical design with line-to-line contact between the acetabular component surface and the acetabular bone is statistically superior in terms of bone ingrowth and probably statistically superior in terms of initial press-fit stability when compared to a peripherally expanded component. Peripherally expanded components appear to offer no advantage over hemispherical components in terms of clinical outcome and are statistically inferior to hemispherical components in radiologic parameters at 7 years follow-up