Introduction & Aims. In other medical fields, smart implantable devices are enabling decentralised monitoring of patients and early detection of disease. Despite research-focused smart orthopaedic implants dating back to the 1980s, such implants have not been adopted into regular clinical practice. The hardware footprint and commercial cost of components for sensing, powering, processing, and communicating are too large for mass-market use. However, a low-cost, minimal-modification solution that could detect loosening and infection would have considerable benefits for both patients and healthcare providers. This proof-of-concept study aimed to determine if loosening/infection data could be monitored with only two components inside an implant: a single-element sensor and simple communication element. Methods. The sensor and coil were embedded onto a representative cemented total knee replacement. The implant was then cemented onto synthetic bone using polymethylmethacrylate (PMMA). Wireless measurements for loosening and infection were then made across different thicknesses of porcine tissue to characterise the sensor's accuracy for a range of implantation depths. Loosening was simulated by taking measurements before and after compromising the implant-cement interface, with fluid influx simulated with phosphate-buffered saline solution. Elevated temperature was used as a proxy for infection, with the sensor calibrated wirelessly through 5 mm of porcine tissue across a temperature range of 26–40°C. Results. Measurements for loosening and infection could be acquired simultaneously with a duration of 4 s per measurement. For loosening, the debonded implant-cement interface was detectable up to 10 mm with 95% confidence. For temperature, the sensor was calibrated with a root mean square error of 0.19°C at 5 mm implantation depth and prediction intervals of ±0.38°C for new measurements with 95% confidence. Conclusions. This study has demonstrated that with only two onboard electrical components, it is possible to wirelessly measure cement debonding and elevated temperature on a smart implant. With further development, this minimal hardware/cost approach could enable mass-market smart arthroplasty implants

Prosthetic joint infection (PJI) is a complex disease that causes significant damage to the peri-implant tissue. Developing an animal model that is clinically relevant in depicting this disease process is an important step towards developing novel successful therapies. In this study, we have performed a thorough histologic analysis of peri-implant tissue harvested post Staphylococcus aureus (S. aureus) infection of a cemented 3D-printed titanium hip implant in rats.

Sprague-Dawley rats underwent left hip cemented 3D-printed titanium hemiarthroplasty via posterior approach under general anesthesia. Four surgeries were performed for the control group and another four for the infected group. The hip joint was inoculated with 5×10⁹ CFU/mL of S. aureus Xen36 prior to capsule closure. The animals were scarified 3 weeks after infection. The femur was harvested and underwent micro-CT and histologic analysis. Hematoxylin and eosin (H&E), as well as Masson's trichrome (MT) stains were performed. Immunohistochemistry (IHC) using rabbit antibody for S. aureus was also used to localize bacterial presence within femur and acetabulum tissue .

The histologic analysis revealed strong resemblance to tissue changes in the clinical setting of chronic PJI. IHC demonstrated the extent of bacterial spread within the peri-implant tissue away from the site of infection. The H&E and MT stains showed 5 main features in infected bone: 1) increased PMNs, 2) fibrovascular inflammation, 3) bone necrosis, and 4) increased osteoclasts 5) fibrosis of muscular tissue and cartilage. Micro CT data showed significantly more osteolysis present around the infected prosthesis compared to control (surgery with no infection).

This is the first clinically relevant PJI animal model with detailed histologic analysis that strongly resembles the clinical tissue pathology of chronic PJI. This model can provide a better understanding of how various PJI therapies can halt or reverse peri-implant tissue damage caused by infection.

It has been suggested that occult infection of joint prostheses contributes to a proportion of aseptic loosening. The aims of the study were to determine the incidence of occult infection in a sample of patients undergoing revision surgery for aseptic loosening and examine the role of ultrasound sonication in its detection. A prospective trial was conducted at Christchurch and Burwood Hospitals. At the time of revision surgery, intra-operative tissue and fluid samples were taken. The removed prosthesis was immersed in saline solution in a sterile plastic container, and then sonicated. The sonicate fluid underwent prolonged routine cultures (14 days) to increase the rate of detection of slow growing organisms. The cases were patients undergoing revision surgery for aseptic loosening or infection. The control group was comprised of patients having revision surgery for any other indication. These implants were subjected to the same protocol as the study group. A total of 122 patients were included in the study; 54 in the Aseptic Loosening [AL] group, 15 Infections and 53 controls. There were significantly more smokers in the AL group and less smokers in the control group (p=0.04 and p=0.04 respectively). The mean age for revision in the Infection and Periprosthetic fracture groups was less than those of other groups (p=0.007 and p=0.02) respectively. There were 18 cases with positive intra-operative cultures. Eight of those were in the aseptic group (i.e. 14.8% of the group). Conventional sampling techniques were positive in 17 of 18 cultures (94%). Sonication was only positive in 10 out of the 18 cultures (56%). Sonication was concordant with the conventional sampling techniques in half of the positive cultures in the AL group and overall. The only bacteria to be isolated from sonicate cultures were Staphylococcus Aureus and Coagulase Negative Staphylococci. Diabetes Mellitus was the only risk factor to have a significant association with having a positive culture result (p=0.03). There was also a significant association with having raised pre-operative Neutrophil differential count or inflammatory markers with having a positive culture (p=0.0001). However this association was not present when the AL group was examined separately. There was a significant rate of positive culture results in the aseptic loosening group of around 15%. Ultrasound sonication was less sensitive than current sampling techniques with no apparent added benefit. This paper does not support the hypothesis that occult infection is a significant driver of aseptic loosening

Increasing femoral offset in total hip replacement (THR) has several benefits including improved hip abductor strength and enhanced range of motion. Biomechanical studies have suggested that this may negatively impact on stem stability. However, it is unclear whether this has a clinical impact. Using data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), the aim of this study was to determine the impact of stem offset and stem size for the three most common cementless THR prostheses revised for aseptic loosening.

The study period was September 1999 to December 2020. The study population included all primary procedures for osteoarthritis with a cementless THR using the Corail, Quadra-H and Polarstem. Procedures were divided into small and large stem sizes and by standard and high stem offset for each stem system. Hazard ratios (HR) from Cox proportional hazards models, adjusting for age and gender, were performed to compare revision for aseptic loosening for offset and stem size for each of the three femoral stems.

There were 55,194 Corail stems, 13,642 Quadra-H stem, and 13,736 Polarstem prostheses included in this study. For the Corail stem, offset had an impact only when small stems were used (sizes 8-11). Revision for aseptic loosening was increased for the high offset stem (HR=1.90;95% CI 1.53–2.37;p<0.001).

There was also a higher revision risk for aseptic loosening for high offset small size Quadra-H stems (sizes 0-3). Similar to the Corail stem, offset did not impact on the revision risk for larger stems (Corail sizes 12-20, Quadra-H sizes 4-7). The Polarstem did not show any difference in aseptic loosening revision risk when high and standard offset stems were compared, and this was irrespective of stem size.

High offset may be associated with increased revision for aseptic loosening, but this is both stem size and prosthesis specific.

Objectives

Investigate the incorporation of an antibiotic in bone cement using liposomes (a drug delivery system) with the potential to promote osseointegration at the bone cement interface whilst maintaining antibiotic elution, anti-microbiological efficacy and cement mechanical properties.

Prosthetic joint infection and aseptic loosening are associated with significant morbidity. Antibiotic loaded bone cement is commonly used and successfully reduces infection rates; however, there is increasing resistance to the commonly used gentamicin.

Previous studies have shown gentamicin incorporated into bone cement using liposomes can maintain the cement's mechanical properties and improve antibiotic elution.

The phospholipid phosphatidyl-l-serine has been postulated to encourage surface osteoblast attachment and in a liposome could improve osseointegration, thereby reducing aseptic loosening.

Preliminary clinical isolate testing showed excellent antimicrobial action with amoxicillin therefore the study aims were to test amoxicillin incorporated into bone cement using liposomes containing phosphatidyl-l-serine in terms of antibiotic elution, microbiological profile and mechanical properties.

INTRODUCTION

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

INTRODUCTION

Joint replacement is one of the most common orthopaedic procedures, with over 2 million surgeries performed each year across the globe. Loss of implant fixation, or aseptic loosening, is the leading cause of revision following primary joint replacement, accounting for ∼25% of all revision cases [1]. However, diagnosis of aseptic loosening and its underlying causes remain challenging due to the low sensitivity and specificity of plain radiographs. To address this, we propose a novel approach inspired by [2] involving the use of a self-sensing bone cement (by imparting strain-dependent electrical conductivity or piezoresistivity) combined with electrical impedance tomography (EIT). Piezoresistivity is imparted to cement via incorporation of micro/nanoscale conductive fillers. Therefore mechanical effects such as loosening and cracks will manifest as a conductivity change of the cement. This work explores if EIT is able to detect strains and cracks within the bone cement volume.

Introduction

A search of the literature indicates several constrained total knee arthroplasty (TKA) systems are at risk for articular surface lockdown bolts backing out. The backing out of a lockdown bolt may lead to an unstable and/or painful knee and may necessitate revision. Upon backing out, the bolt may damage implant components and surrounding tissues. To date, studies in the literature have not simulated or replicated loosening of bolts in TKA. Therefore, the objectives of this study were to 1) develop a set of physiological loading parameters that challenge bolted articular surfaces; 2) evaluate whether significant bolt torque is lost during application of this loading to a CCK device with a bolt as a secondary locking mechanism.

Aim

The aim of our study was to evaluate culture-negative prosthetic joint infections in patients who were pre-operatively evaluated as aseptic failure.

Non-large head Metal-on-metal (MoM) hip replacements were seen as a solution to concerns about implant wear in younger patients. Mid-term loosening of once well-fixed hydroxyapatite (HA) coated femoral stems was recently observed in select MoM patients upon revision surgery. Accordingly, an implant retrieval study was undertaken to examine the incidence of aseptic loosening of in HA-coated femoral stems with MoM, ceramic on ceramic (CoC) and metal on polyethylene (MoP) bearing couples.

A single-centre implant retrieval lab reviewed 44 hydroxyapatite (HA)-coated titanium wedge taper stems of the same design retrieved over a period of 9 years. Ten were MoM articulations, 23 MoP and 11 CoC. Head sizes ranged from 28 to 40 with only four 40mm heads, all of which were MoM. Reason for revision, duration of implantation, femoral head size, patient age and body mass index was recorded for each retrieval. Goldberg corrosion scores were determined for the taper surfaces of each retrieval, with ‘0’ indicating no corrosion and ‘3’ indicating severe corrosion. Logistic regression analysis, Wilcoxan Rank Sum and Fischer's exact test were used for statistical analysis.

Aseptic loosening was the listed reason for revision in 18 of 44 cases. MoM bearing was associated with increased probability of aseptic loosening (Odds ratio 7.1 (95%CI 1.1–47.0) p=0.042). Severity of corrosion was also associated with aseptic loosening (Odds ratio 2.75 (95%CI 1.1–6.6) p=0.02). Head size and patient age had no correlation. Median time to revision of implants for aseptic loosening was 4.5 years (range: 4.2–7.0 years) for MoM versus 1.4 years (range: 0.3–3.0) for other bearing couples (p=0.004). Aseptic loosening was categorised as early (<=2 years) or mid-term (>2 years). No MoM hips were revised for aseptic loosening in the first 2 years while 8 of the 11 mid-term revisions had MoM articulations (p=0.004). Taper corrosion was more severe in mid-term aseptic loosing cases (p=0.049).

MoM HA-coated hip replacements appear to be associated with increased mid-term aseptic loosening compared to other bearing couples. Patients with MoM HA-coated hip replacements should be monitored regularly beyond the initial 1 to 2 years following surgery. Future analyses will examine the presence and progression of femoral radiolucency prior to revision surgery to determine an approximate timeline of stem loosening in this patient cohort. This research highlights the importance of implant retrieval programs to assess post-revision implant characteristics for early identification of possible device issues.

Background

Hard-on-hard bearings showed advantages of reduction of wear rates, osteolysis and aseptic loosening in total hip arthroplasty (THA). A new combination of ceramic-on-metal (COM) was developed to compensate the disadvantages of MOM and COC. COM showed good short-term results in vitro and in vivo studies. There was no report of stripe wear and metal ion level elevation. Our study was designed to evaluate the wear pattern of this bearing in early loosening THA.

Background

The process of osteolysis is well studied both in vivo and in vitro. Although multiple pathways have been implicated in osteolytic change and animal models have been developed there are few human tissue studies. There are no extensive human tissue studies comparing osteoarthritic hips to well fixed and loose prostheses.

Introduction

Computer Tomography (CT) imaging has been limited to beam hardening artefacts until now. Literature has failed to describe sensitivity and specifity for loosening of endoprothesis in CTs, as metal artefacts have always influenced the diagnostic value of CTs.

In recent years a new technology has been developed, the Dual Energy CT. Dual Energy CT scanners simultaneously scan with two tubes at different energy levels, most commonly 100kVp and 140kVp. Furthermore pictures gained from Dual Energy CTs are post-processed with monoenergetic reconstruction, which increases picture quality while further reducing metal artefacts.

This promising technology has increased the diagnostic value preventing more radiation for the patients, for example in detection of kidney stones or to map lung perfusion. In the musculoskeletal imaging it has not been established yet and further clinical investigations are necessary.

Thus the aim of this study is to describe sensitivity and sensibility for endoprothesis loosening of this novel technology.

Background

Polyethylene wear in both cemented and uncemented total hip arthroplasty (THA) lead to generation of particles with their access to the interface which has been responsible for periprosthetic osteolysis and subsequent loosening of cup and stem. Many studies have been published studying the pattern of polyethylene wear and its relation to the type of implant (cemented/ uncemented cup or ceramic/metal head) used. No study in our knowledge has strictly focused on the effect of cemented versus uncemented stem on the polyethylene wear rates. We tried to compare the polyethylene wear rates reckoned with software (Poly Ware REV 7) of ultra high molecular weight polyethylene (UHMWPE) in hybrid and uncemented THA and its effect on complications of total hip replacements.

Hip simulator studies with ceramic-on-metal (COM) predicted less wear than metal-on-metal (MOM: Isaac. 2009). While clinical evidence is scant, two COM case reports described pseudotumors with adverse cup positioning (Deshmukh 2012, Koper 2014). It would appear that our Korean case report is the first to describe pseudotumor formation in well-positioned COM arthroplasty and including detailed failure analysis. A 50-year old female (active salesperson) had bilateral avascular necrosis of her femoral heads. A left metal-on-polyethylene (MPE) hip was performed at outside institution in 2003. At our 3-yrs evaluation, radiographs showed well-functioning MPE hip. Five years later she complained of gradual left-hip pain (2011). Radiographs and CT scan demonstrated wear, osteolysis and loosening of both components. The revision in 2011 was by COM (Fig. 1), using S-ROM stem/sleeve, 36mm ceramic head (Biolox-delta), a CoCr liner and 54mm shell (Pinnacle: Depuy Inc). Cup inclination and anteversion were considered appropriate at 45° and 20° respectively; femoral anteversion of 15° was also appropriate.

At 1-yr follow-up patient complained of mild discomfort in left COM hip (2012). Range of motion was painless and normal. Examination revealed a soft, non-tender swelling (2×3cm) in left inguinal region with no inflammation and radiographs were normal (Fig. 1a). One month later the patient complained of left hip pain, the previously noted swelling had increased in size, and she started to limp. Radiographs showed cup migration with increased inclination. CT scans showed a circumscribed lesion extending into iliopsoas region (Fig 2). Serum cobalt and chromium levels were high at 2.4 and 22.5µg/ L, respectively.

At revision the pseudotumor and surrounding inflamed synovium was excised. The cystic soft-tissue swelling (stained black) extended into the joint (Fig. 2a). The ceramic head showed a large “black stripe” across the dome (Fig 2b). The cup was loose while the femoral stem was well fixed. Operative cultures of soft tissues and joint fluid were negative for infection while histopathology was consistent for metallosis (Fig. 3). Aggressive debridement was carried out, acetabular defects were filled with bone graft. Revision incorporated 32mm ceramic head (Biolox-delta), highly cross-linked liner and 52mm trabecular-metal shell (Depuy). Functionally the patient has continued to improve. By 6 months, serum ion concentrations decreased to Co:1.3 and Cr:2.54µg/ L with most recent ion levels lower still (Co:0.66 and Cr:0.42µg/ L).

Ceramic head surfaces showed normal wear appearance. The large gray stripe identified on the highly polished dome contained Co and Cr metal-transfer from the CoCr liner (Fig. 2b). Thin gray stripes on equatorial head regions (x4 rougher than dome) represented contamination by Ti, Al and V, typical of adverse impingement against Ti6Al4V neck (Clarke 2013). There was a 100–150um defect on rim of CoCr liner as a result of impingement. Cup out-of-roundness was 476um compared to only 7um for ceramic head, thus cup wear dominated at 25–30mm³ volume. This case report was illustrative of the unpredictable and seldom diagnosed risk of habitual cup-to-neck impingement and the risk of relying on pristine simulator studies to predict outcomes in novel THA bearings.

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Introduction

High-flexion knee implants have been developed to accommodate a large range of motion (ROM > 120°) after total knee arthroplasty (TKA). In a recent follow-up study, Han et al. [1] reported a disturbingly high incidence of femoral loosening for high-flexion TKA. The femoral component loosened particularly at the implant-cement interface. Highly flexed knee implants may be more sensitive to femoral loosening as the knee load is high during deep knee flexion [2], which may result in increased tensile and/or shear stresses at the femoral implant fixation.

The objective of this study was to analyse the load-transfer mechanism at the femoral implant-cement interface during deep knee flexion (ROM = 155°). For this purpose, a three-dimensional finite element (FE) knee model was developed including high-flexion TKA components. Zero-thickness cohesive elements were used to model the femoral implant-cement interface. The research questions addressed in this study were whether high-flexion leads to an increased tensile and/or shear stress at the femoral implant-cement interface and whether this would lead to an increased risk of femoral loosening.

Frontal and lateral plain radiographs are the first choice for follow-up observations of the osteotomy boundary that faces the femoral and tibial components of a TKA. However, as plain radiographs provide no information in the image depth direction, it is difficult to determine the exact position of early-stage bone radiolucent lines. A new tomosynthesis technique, which uses both iterative reconstruction and metal extraction methods, has recently attracted attention. We report that this technique provides multi-slice images of the boundary between the metallic implant and the osteotomy surface, which is difficult to observe using conventional multi-slice imaging methods such as CT and MRI, and permits semi-three-dimensional evaluations of polyethylene wear.

Introduction

Cementless grit-blasted tapered-wedge titanium femoral stems are being used with increasing frequency in hip arthroplasty because of excellent long-term outcomes. However, periprosthetic femur fracture is a potentially worrisome phenomenon in these types of femoral stems. The aim of this study is to report the incidence of stem loosening in association with periprosthetic femur fractures following hip arthroplasty using cementless grit-blasted tapered-wedge stems.

We describe the association between post-operative femoral stem radiological appearances and aseptic failure of THA (total hip arthroplasty) following a retrospective review of records and radiographs of all patients attending for follow-up between August 2002 and August 2003 who had a cemented Charnley femoral stem and either a cemented polyethylene acetabular cup inserted. Femoral stem aseptic loosening was defined either by findings at revision surgery, the definite radiographic loosening criteria of Harris or progressive endosteal cavitation across zones as described by Gruen. Well-fixed control THAs were defined as those that demonstrated none of the radiographic features of aseptic loosening or ‘at risk’ signs as described by Wroblewski. Parameters measured were: Alignment, Barrack grade of cementation, cement mantle width of the cement mantle and the presence and width of any radiolucent lines.

Sixty-three hips were entered into the aseptic failure group and 138 into the control group. The alignment of the femoral stem was not associated with failure (p=0.283). Thickness of the cement mantle was statistically associated with failure in Gruen zones 6 (p=0.040) and Gruen zone 7 (p=0.003). A significant association for the presence of radiolucent lines was found for Gruen zones 3 (p=0.0001) and 5 (p=0.0001). The grade of cementation as measured by the Barrack grade was strongly associated with failure for grades C (p=0.001) and D (p=0.001).

This study has demonstrated that easily applied radiological criteria can be used to identify ‘at risk’ Charnley THAs from the immediate post-operative AP radiograph.

Between 1993 and 2003, 67 consecutive revision total hip arthroplasties were performed in 65 patients, including 52 women and 13 men, using hydroxyapatite (HA) granules supported by a Kerboull-type reinforcement acetabular device. The average age at the time of index surgery was 68.6 years. The Acetabular bone loss according to the American Academy of Orthopaedic Surgeons (AAOS) system was type II for 7 hips, type III for 58 hips, and type IV for one hip. The Kerboull-type acetabular reinforcement device used was Kerboull Cross Plate in 18 hips and KT Plate in 49 hips. HA granules of sizes 0.9 to1.2 mm (G4) and 3.0–5.0 mm (G6) were mixed in a ratio of 1:1. Autografts were used to reconstruct the major segmental defects in 7 hips. At the time of this study 30 hips were lost of follow-up. Among 30 hips 22 hips were lost of follow-up because of the death of the patients. The remaining 37 hips were examined clinically and radiologically. The mean follow-up period of the series was 12.8 years. Complications were examined and clinical evaluation was done using Japanese Orthopaedic Association (JOA) hip score. The criterion for loosening of the acetabular component was cup migration exceeding 3 mm or angular rotation exceeding 3 degrees or breakage of the device. Among the entire series of 67 hips postoperative complications included dislocation in 3 hips, infection in 2 hips and revision in 4 hips. Two hips were revised for loosening and the other two hips were revised for infection. The JOA hip score increased from a mean value of 48.0 preoperatively to 76.8 at the last follow-up. Radiologically 5 hips were loose. Two hips among them were revised. Survival rate of the acetabular component at 10 years was 97.1% using acetabular revision for loosening as the end point and 90.6% using radiological loosening as the end point. Acetabular reconstruction with HA granules and a Kerboull-type acetabular device provided satisfactory clinical and radiographic results at 12.8 post-operative years.