Osteoporotic fractures tend to be more challenging than fractures in healthy bone and the efficacy of metal screw fixation decreases with decreasing bone mineral density making it more difficult for such screws to gain purchase. This leads to increased complication rates such as malunion, non-union and implant failure (1). Bioresorbable polymer devices have seen clinical success in fracture fixation and are a promising alternative for metallic devices but are rarely used in the osteoporotic population. To address this, we are developing a system that may allow osteoporotic patients to avail of bioresorbable devices (2) but it is important to establish if patients have any reservations about having a plastic resorbable device instead of a metal one. Therefore the aim of this study was to explore the acceptability of bioresorbable fracture fixation devices to people with osteoporosis. A cross sectional descriptive study was conducted in a UK wide population using convenience sampling. An online survey comprising nine survey questions and nine demographic questions was developed in Microsoft Teams and tested for face validity in a small pilot study (n=6). Following amendments and ethical approval, the survey was distributed by the Royal Osteoporosis Society on their website and social media platforms. People were invited to take part if they lived in the UK, were over 18 years old and had been diagnosed with osteoporosis. The survey was open for three weeks in May 2023. Responses were analysed using descriptive statistics.Abstract
Objectives
Methods
Accurate and precise acetabular reaming is a requirement for the press-fit stability of cementless acetabular hip replacement components. The accuracy of reaming depends on the reamer, the reaming technique and the bone quality. Conventional reamers wear with use resulting in inaccurate reaming diameters, whilst the theoretical beneficial effect of ‘whirlwind’ reaming over straight reaming has not previously been documented. Our aim was to compare the accuracy and precision of single use additively-manufactured reamers with new conventional reamers and to compare the effect of different acetabular reaming techniques. Forty composite bone models, half high-density and half low-density, were reamed with a new 61 mm conventional acetabular reamer using either straight or ‘whirlwind’ reaming techniques. This was repeated with a 61 mm single use additively-manufactured reamer. Reamed cavities were scanned using a 3D laser scanner with mean diameters of reamed cavities compared using the Mann-Whitney U test to determine any statistically significant differences between groups (p<0.05) [Fig. 1).Aims
Materials and Methods
Current strategies for bone repair have accepted limitations and the search for synthetic graft materials or for scaffolds that will support ex vivo bone tissue engineering continues. Bioprospecting has led to increased interest in potential applications for marine organisms and their by-products and biomimetic strategies have led to the investigation of naturally occurring porous structures as templates for bone growth. As a rich source of mineralising porous organisms, our seas and oceans could provide new directions for bone tissue engineering that may enhance
We aimed to demonstrate the clinical safety of a novel anatomic cementless ceramic hip resurfacing device. Concerns around the safety of metal on metal arthroplasty have made resurfacing less attractive, while long term function continues to make the concept appealing. Biolox Delta ceramic is now used in more than 50% of all hip arthroplasties, suggesting that it's safety profile is acceptable. We wondered if a combination of these concepts might work? The preclinical testing of anatomic hip resurfacing device developed by our group was presented last year. A twenty patient safety study was designed. Patients had to be between the ages of 18 and 70. The initial size range was restricted to femoral heads between 46 and 54, representing the common sizes of hip resurfacing. The primary outcomes were clinical safety, PROMs and radiological control. Secondary outcomes include CTRSA and metal ion levels. 20 patients were recruited, aged 30–69. 7 were women and 13 were men. There were no operative adverse events in their operations undertaken between September 2017 and February 2018. One patient had a short episode of atrial fibrillation on the second postoperative day, and no other complications. At three months the median oxford hip score had risen from 27 (range 14–38) to 46 (31–48). Cobalt and chromium levels were almost undetectable at 3 months. Fixation appeared satisfactory in all patients, with no migration detected in either component. CTRSA is in process. The initial safety of a novel cementless ceramic resurfacing device is demonstrated by this data. The 10 year, 250 case efficacy study will continue in 5 other European centres.
Hip resurfacing remains a safe and effective option according to registry data. Results in women were less reliable, in part owing to soft tissue impingement. Biolox Delta ceramic bearing couples are now in widespread use with very low complication rates. We set about merging these three elements to develop a novel hip resurfacing arthroplasty. Contours of both acetabular and femoral components were generated from biometric data, adapted to the constraints of ceramic machining, to ensure that radii blended from the bearing surface avoiding any sharp boundaries. Plasma spray coating with titanium and hydroxyapatite direct onto ceramic was developed and tested using shear, tensile and taber abrasion testing. Wear testing was carried out to 5 million cycles according to the ASTM. Destructive testing was carried out in a variety of test conditions and angles. Cadaveric testing demonstrated stability using a single use disposable instruments for both conventional and patient specific procedures. Very low dose CT enabled the entire interface to be observed as the Ceramic is radiolucent, enhancing migration analysis, which will be undertaken at 4 intervals to confirm stability. Functional scores and gait analysis will be used in the safety study. The CE study recruitment is underway, with first in human trials starting in summer 2017. PMA submission will follow the safety study. Commercial release of the device in Europe is unlikely before 2019, and in the USA may not be until 2027. The path to novel device development in 2017 is very costly in time and money.
The treatment of patients with osteoarthritis of the knee and associated extra-articular deformity of the leg is challenging. Current teaching recognises two possible approaches: (1) a total knee replacement (TKR) with intra-articular bone resections to correct the malalignment or (2) an extra-articular osteotomy to correct the malalignment together with a TKR (either simultaneously or staged). However, a number of these patients only have unicompartmental knee osteoarthritis and, in the absence of an extra-articular deformity would be ideal candidates for joint preserving surgery such as unicompartmental knee replacement (UKR) given its superior functional outcome and lower cost relative to a TKR [1). We report four cases of medial unicondylar knee replacement, with a simultaneous extra-articular osteotomy to correct deformity, using novel 3D printed patient-specific guides (Embody, UK) (see Figure 1). The procedure was successful in all four patients, and there were no complications. A mean increase in the Oxford knee score of 9.5, and in the EQ5D VAS of 15 was observed. To our knowledge this is the first report of combined osteotomy and unicompartmental knee replacement for the treatment of extra-articular deformity and knee osteoarthritis. This technically challenging procedure is made possible by a novel 3D printed patient-specific guide which controls osteotomy position, degree of deformity correction (multi-plane if required), and orientates the saw-cuts for the unicompartmental prosthesis according to the corrected leg alignment. Using 3D printed surgical guides to perform operations not previously possible represents a paradigm shift in knee surgery. We suggest that this joint preserving approach should be considered the preferred treatment option for suitable patients.
Patient Specific Instrumentation (PSI) has the potential to allow surgeons to perform procedures more accurately, at lower cost and faster than conventional instrumentation. However, studies using PSI have failed to convincingly demonstrate any of these benefits clinically. The influence of guide design on the accuracy of placement of PSI has received no attention within the literature. Our experience has suggested that surgeons gain greater benefit from PSI when undertaking procedures they are less familiar with. Lateral unicompartmental knee replacement (UKR) is relatively infrequently performed and may be an example of an operation for which PSI would be of benefit. We aimed to investigate the impact on accuracy of PSI with respect to the area of contact, the nature of the contact (smooth or studded guide surfaces) and the effect of increasing the number of contact points in different planes. A standard anatomy tibial Sawbone was selected for use in the study and a computed tomography scan obtained to facilitate the production of PSI. Nylon PSI guides were printed on the basis of a lateral UKR plan devised by an orthopaedic surgeon. A control PSI guide with similar dimensions to the cutting block of the Oxford Phase 3 UKR tibial guide was produced, contoured to the anterior tibial surface with multiple studs on the tibial contact surface. Variants of this guide were designed to assess the impact of design features on accuracy. These were: a studded guide with a 40% reduction in tibial contact area, a non-studded version of the control guide, the control guide with a shim to provide articular contact, a guide with an extension to allow distal referencing at the ankle and a guide with a distal extension and an articular shim. All guides were designed with an appendage that facilitated direct attachment to a navigation machine (figure 1). 36 volunteers were asked to place each guide on the tibia with reference to a 3D model of the operative plan. The order of placement was varied using a counterbalanced latin square design to limit the impact of the learning effect. The navigation machine recorded deviations from the plan in respect of proximal-distal and medial-lateral translations as well as rotation around all three axes. Statistical analysis was performed on the compound translational and rotational errors for each guide using ANOVA with Bonferroni correction with statistical significance at p<0.05.Introduction
Method
Opening wedge high tibial osteotomy is an attractive surgical option for physically active patients with early osteoarthritis and varus malalignment. Unfortunately use of this surgical technique is frequently accompanied by an unintended increase in the posterior tibial slope, resulting in anterior tibial translation, and consequent altered knee kinematics and cartilage loading(1). To address this unintended consequence, it has been recommended that the relative opening of the anteromedial and posterolateral corners of the osteotomy are calculated pre-operatively using trigonometry (1). This calculation assumes that the saw-cut is made parallel to the native posterior slope; yet given the current reliance on 2D images and the ‘surgeon's eye’ to guide the saw-cut, this assumption is questionable. The aim of this study was to explore how accurately the native posterior tibial slope is reproduced with a traditional freehand osteotomy saw-cut, and whether novel 3D printed patient-specific guides improve this accuracy. 26 fourth year medical students with no prior experience of performing an osteotomy were asked to perform two osteotomy saw-cuts in foam cortical shell tibiae; one freehand, and one with a 3D printed surgical guide (Embody, London) that was designed using a CT scan of the bone model. The students were instructed to aim for parallelity with a hinge pin which had been inserted (with the use of a highly conforming 3D printed guide) parallel to the posterior slope of the native joint. For the purpose of analysis, the sawbones were consistently orientated along their mechanical and anatomical tibial axes using custom moulded supports. Digital photographs taken in the plane of the osteotomy were analysed with ImageJ software to calculate the angular difference in the sagittal plane between the hinge-pin and saw-cut. Statistical analysis was performed with SPSS v21 (Chicago, Illinois); a paired t-test was used to compare the freehand and patient-specific guide techniques. Statistical significance was set at a p-value <0.05.Introduction
Methods
Metal on metal press-fit acetabular cups are the worst performing acetabular cup type with severe failure consequences compared to cups made from more inert materials such as polyethylene or ceramic. The cause of failure of these cup types is widely acknowledged to be multi-factorial, therefore creating a complex scenario for analysis through clinical studies. A factorial analysis has been carried out using an experimentally validated finite element analysis to investigate the relative influence of four input factors associated with acetabular cup implantation on output parameters indicating potential failure of the implantation. These input factors were: cup material stiffness; cup inclination; cup version; cup seating; and level of press-fit. The output parameter failure indicators were: wear; tensile strains in the underlying bone; bone remodelling; and cup-bone micromotions. The factorial analysis concluded that the most significant influence was that of cup inclination on wear, and the second most significant was the influence of the level of press-fit on bone remodelling at the acetabular rim. Significant influence was also observed between version angle and wear, and cup-seating and micro-motion. The results demonstrated the clear multi-factorial nature of implant failure and highlighted the importance of correct implant positioning and fit.
Problematic bone defects are encountered regularly in orthopaedic practice particularly in fracture non-union, revision hip and knee arthroplasty, following bone tumour excision and in spinal fusion surgery. At present the optimal source of graft to ‘fill’ these defects is autologous bone but this has significant drawbacks including harvest site morbidity and limited quantities. Bone marrow has been proposed as the main source of osteogenic stem cells for the tissue-engineered cell therapy approach to bone defect management. Such cells constitute a minute proportion of the total marrow cell population and their isolation and expansion is a time consuming and expensive strategy. In this study we investigated human bone marrow stem cells as a potential treatment of bone defect by looking at variability in patient osteogenic cell populations as a function of patient differences. We produced a model to predict which patients would be more suited to cell based therapies and propose possible methods for improving the quality of grafts. Bone marrow was harvested from 30 patients undergoing elective total hip replacement surgery in Musgrave Park Hospital, Belfast (12 males, 18 females, age range 52-82 years). The osteogenic stem cell fraction was cultured and subsequently analysed using colony forming efficiency assays, flow cytometry, fluorescence activated cell sorting and proteomics.Introduction
Methods
This study examines the effect of injecting an inert synthetic lubricant, perfluoroalkylether (PFAE16350), as a mechanical joint lubricant to prevent the development of osteoarthritis in a surgically induced model of osteoarthritis in the adult guinea pig.
After wound closure, the animals were randomly assigned to 1 of 2 groups: (1) Single intra-articular injection of 1ml synthetic, sterile lubricant (PFAE16350) or (2) Control group with single intra-articular injection of 1ml 0.9% sterile saline. At 9 weeks after surgery, after sacrifice, knee arthrotomy was performed, the presence of synthetic lubricant noted and the articular cartilages examined for macroscopic evidence of osteoarthritis. These cartilages were then fixed, embedded, sectioned, stained and graded histologically for osteoarthritis according to a modified Mankin scoring system. Immunohistochemical studies were performed to assess for any inflammatory or cytotoxic effect by the lubricant.
Subjective macroscopic assessment of the medial tibial plateau osteophyte was noted to be larger and the articular surface more roughened in the control cases compared to the lubricated cases. Synthetic lubricant was noted at arthrotomy in all cases where it was injected. Guinea-pig joints treated with the synthetic lubricant showed a mean modified Mankin score of 3.0 points compared with the guinea-pig joints treated with saline where the median modified Mankin score was 8.5 points (p<
0.001). There was no evidence of an inflammatory or cytotoxic response by immunohistochemical studies.
This study investigated the relationship between histological, clinical and radiological features of aseptically loose total joint replacements (TJRs) and synovial fluid levels of interleukin (IL)-1b, IL-6, IL-8 and IL-10. Tissue and synovial fluid samples were retrieved from patients undergoing primary (hip; n=15: knee; n=13), or revision of aseptically loose TJRs (hip; n=14: knee; n=9). The presence of inflammatory cells, blood vessels and wear debris in the tissue were assessed on a relative scale. Revision TJRs were assessed for sepsis, migration of the implant, gross loosening and the degree of radiolucency. Cytokine levels in the synovial fluid samples were determined by ELISA. All cytokines were increased in synovial fluid from revision TJRs compared to primary replacements, as were the degree of macrophage and giant cell infiltration (p<
0.01). There was a significant positive correlation between the presence of macrophages and giant cells with the levels of IL-1b, IL-8 and IL-10 (p<
0.05) but not IL-6. The amount of wear debris was related to the presence of macrophages and giant cells (p<
0.01) but not to any of the cytokines. There were no relationships between any of the clinical parameters and the presence of wear debris or the levels of any cytokine with the exception of IL-6 and gross loosening (p<
0.01). Similarly there were no differences between hips and knees for any of the parameters except IL-6, for which higher levels were found in hips (p<
0.05). The results suggest that macrophages and giant cells are responsible for the majority of IL-1b, IL-8 and IL-10 production but another cell type is contributing to IL-6 production. Furthermore, IL-6 does not fit the pattern of the other cytokines as it is upregulated in hip joints compared to knees and correlates with the presence of gross loosening. This may suggest a unique role for IL-6 that requires further investigation.
