Title. Longitudinal Intravital Imaging to Quantify the “Race for the Surface” Between Host Immune Cell and Bacteria for Orthopaedic Implants with S. aureus Colonization in a Murine Model. Aim. To assess S. aureus vs. host cell colonization of contaminated implants vis intravital multiphoton laser scanning microscopy (IV-MLSM) in a murine model. Method. All animal experiments were approved by IACUC. A flat stainless steel or titanium L-shaped pin was contaminated with 10. 5. CFU of a red fluorescent protein (RFP) expressing strain of USA300LAC, and surgically implanted through the femur of global GFP-transgenic mice. IV-MLSM was performed at 2, 4, and 6 hours post-op. Parallel cross-sectional CFU studies were performed to quantify the bacteria load on the implant at 2,4,6,12,18 and 24 hours. Results. 1) We developed a high-fidelity reproducible IV-MLSM system to quantify S. aureus and host cell colonization of a bone implant in the mouse femur. Proper placement of all implants were confirmed with in vivo X-rays, and ex vivo photos. We empirically derive the ROI during each imaging session by aggregating the imaged volume which ranges from (636.4um × 636.4um × 151um) = 0.625 +/- 0.014 mm. 3. of bone marrow in a global GFP-transgenic mouse. 2) IV-MLSM imaging acquisition of the “race for the surface”.In vitro MPLSM images of implants partially coated with USA300LAC (RFP-MRSA) were verified by SEM image. Results from IV-MLSM of RFP-MRSA and GFP. +. host cell colonization of the contaminated implants illustrated the mutually exclusive surface coating at 3hrs, which to our knowledge is the first demonstration of “the race for the surface” between bacteria and host cells via intravital microscopy. 3) Quantifying the “race for the surface” with CFU verification of S. aureus on the implant. 3D volumetric rendering of the GFP. +. voxels and RFP+ voxels within the ROI were generated in Imaris. The voxel numbers suggeste that the fight for the surface concludes ∼3hrs post-infection, and then transitions to an aggressive MRSA proliferation phase. The results of WT control demonstrate a significant increase in CFU by 12hrs post-op for both stainless steel (P<0.01) and titanium (P<0.01). Conclusions. We developed IV-MLSM to quantify the “Race for the Surface” between host cells and contaminating S. aureus in a murine femur implant model. This race is remarkably fast, as the implant surface is completely covered with 3hrs, peak bacterial growth on the implant occurs between 2 and 12 hours and is complete by 12hrs

Introduction

Metal-on-Metal (MoM) bearing surfaces were historically used for young patients undergoing total hip arthroplasty, and remain commonplace in modern hip resurfacing. In theory, it has been postulated that metal ions released from such implants may cross the placental barrier and cause harm to the fetus. In light of this potential risk, recommendations against the use of MoM components in women of child-bearing age have been advocated. The purpose of this systematic review was to evaluate: 1) the Metal-on-Metal bearing types and ion levels found; 2) the concentrations of metals in maternal circulation and the umbilical cord; and 3) the presence of abnormalities in the fetus

BACKGROUND. Total hip revision surgery in cases with previous multiple reconstructive procedures is a challenging treatment due to difficulties in treatment huge bone defects with standard revision prosthetic combinations. A new specially made production system in Electron-Beam Melting (EBM) technology based on a precise analysis of patients' preoperative CT scans has been developed. METHODS. Objectives of design customization in difficult cases are to correctly evaluate patient's anatomy, to plan a surgical procedure and to obtain an optimal fixation to a poor bone stock. The 3D Printing (EBM) technology permits to create an extremely flexible patient matching implant and instrument, with material performances not viable with standard manufacturing process. Dedicated visual 3D tools and instrumentations improve implants congruency according to preoperative plan. Primary stability is enhanced and tailored on patient's anatomy by means of press-fit, iliac stems and the high friction performances of Trabecular Titanium matrix. The use of bone screws and their position is designed to enhance primary stability, even in critical bone conditions, avoiding implant stress shielding and allowing bone integration. 4 cases (2 men and 2 women) of acetabular customized implants were performed. Mean age at surgery was 51.5 years (range 25–72). Patients were reviewed clinically and radiographically at follow-up. RESULTS. No signs of miss-match between intraoperative bone conditions and pre-operative planning were observed. No additional bone grafts or further native bone removal were needed. Biomechanical parameters were restored by using internal modularity (i.e. face-changers / angled spacers). Face-changers allow to correct coverage and anteversion of the acetabular system. Incompatibility or impingement between the stems and new acetabular component was not observed and stem revision was performed in one case. On-table stability proved excellent and no intraoperative complications were observed. All patients underwent an immediate mobilization with full weight-bearing. Mean Harris Hip Score increased significantly from 13.9 (range 6.9–20.6) preoperatively to 75.8 (range 53.9–94) at last follow-up (mean 17.5, range: 10–33), showing an improvement in terms of both pain relief, function and joint mobility. Radiographically neither signs of instability, migration nor tilting were observed. No case of dislocation nor infection were recorded. CONCLUSION. A detailed anatomical reconstruction, in-depth preoperative planning, custom-implant design, high performance of the 3D-printing technology, system modularity and patient-specific surgical tools permitted an effective restoration of the biomechanical joint parameters in these complex revision cases. The optimal primary stability of the implants promoted an early osseointegration with the remaining bone stock. Further studies shall be necessary to assess the performance of these Implants at long-term follow-up

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.

Custom 3D printed implants can be anatomically designed to assist in complex surgery of the bony pelvis in both orthopaedic oncology and orthopaedic reconstruction surgery.

This series includes patients who had major pelvic bone loss after initially presenting with tumours, fractures or infection after previous total hip arthroplasty. The extent of the bone loss in the pelvis was severe and therefore impossible to be reconstructed by conventional ‘off –the-shelve’ implants. The implant was designed considering the remaining bony structures of the contra-lateral hemi- pelvis, to provide an anatomical, secured support for the reconstructed hip joint. The latter was realised by strategically orientated screws and by porous structures (an integral part of the implant), which stimulates osseointegration. A custom pelvic implant was designed, manufactured and 3D printed. Reconstruction of the pelvis was performed together with a cemented (bipolar bearing) acetabular cup. In some cases, a proximal femoral replacement was also necessary to compensate for bony defects.

All patients had sufficient range of motion (ROM) at the hip with post-operative stability. It has been verified, at six and twelve months postoperatively, that there is a strong hold of the implant due to osseointegration. Additionally, in patients whose posterior acetabular wall was missing, it was discovered that the implant assisted in bone formation and covered the entire posterior surface of the implant.

All patients in this study managed with this novel treatment option, proved to have a stable pelvic reconstruction with restoration of leg lengths, improvement of strength and independent ambulation at short and medium term follow-up.

Introduction

This study reports on minimum 2 year follow up outcomes on functional and quality of life of patients after undergoing bilateral osseointegration in comparison to traditional socket prosthesis.

Aim

To evaluate the bacterial counts of sonicatied implants in patients with osteoarticular infections. Various studies have demostrated the usefulness of sonication of retrieved implants in order to provide an accurate microbiological diagnosis. Although cutoff values for original sonicate counts have been established, the use of centrifugation may influence these values

We present the indications and outcomes of a series of custom 3D printed titanium acetabular implants used over a 9 year period at our institution (Sydney, Australia), in the setting of revision total hip arthroplasty.

Individualised image-based case planning with additive manufacturing of pelvic components was combined with screw fixation and off-the-shelf femoral components to treat patients presenting with failed hip arthroplasty involving acetabular bone loss. Retrospective chart review was performed on the practices of three contributing surgeons, with an initial search by item number of the Medicare Benefits Scheme linked to a case list maintained by the manufacturer. An analysis of indications, patient demographics and clinical outcome was performed.

The cohort comprised 65.2% female with a median age of 70 years (interquartile range 61–77) and a median follow up of 32.9 months (IQR 13.1 - 49.7). The indications for surgery were infection (12.5%); aseptic loosening (78.1%) and fracture (9.4%), with 65.7% of cases undergoing previous revision hip arthroplasty. A tumour prosthesis was implanted into the proximal femur in 21.9% of cases. Complications were observed in 31.3% of cases, with four cases requiring revision procedures and no deaths reported in this series. Kaplan-Meier analysis of all-cause revision revealed an overall procedure survival of 88.7% at two years (95%confidence interval 69 - 96.2) and 83.8% (95%CI 62 - 93.7) at five years, with pelvic implant-specific survival of 98% (95%CI 86.6 - 99.7) at two and five year follow up.

We conclude that an individualised planning approach for custom 3D printed titanium acetabular implants can provide high overall and implant-specific survival at up to five years follow up in complex cases of failed hip arthroplasty and acetabular bone loss.

Introduction

Osseointegration is a potential treatment option for transfemoral amputees experiencing socket related problems. Till this date, there is little data assessing the feasibility and advantages of osseointegration in individuals with transtibial amputations.

Introduction

Continuous compression implants (CCIs) are small memory alloy bone staples that can provide continuous compression across a fracture site, which change shape due to temperature changes. Reviews of CCIs in orthopaedics have documented their use in mainly foot and ankle surgery, with very limited descriptions in trauma. They could be beneficial in the management of complex or open injuries due to their low profile and quick insertion time. The aim of this case series were to clarify the use of CCIs in modern day limb reconstruction practice.

Anatomically specific fixation devices have become mainstream, yet there are anatomical regions and clinical conditions where no pre-contoured plates are available, such as for glenohumeral arthrodesis. In a case series of 4 glenohumeral arthrodesis patients, a consultant orthopaedic surgeon at GCUH implemented 3D printing technology to create reconstructions of each patient's shoulder girdle to pre-contour arthrodesis plates. Our aim was to quantify the cost-benefit & intra-operative time savings of this technique in glenohumeral arthrodesis.

We hypothesized that the use of 3D printing for creating patient specific implants through pre-operative contouring of plates will lead to intra-operative time and cost savings by minimising time spent bending plates during surgery.

This study analysed 4 patients who underwent shoulder arthrodesis by a single consultant orthopaedic surgeon at GCUH between 2017-2021. A CT-based life-size model of each patient's shoulder girdle was 3D printed using freely available computer software programs: 3D Slicer, Blender, Mesh Mixer & Cura.

Once the patient's 3D model was created, plate benders were used to contour the plate pre-op, which was then sterilised prior to surgery. Arthrodesis was performed according to AO principles of fixation. The time spent pre-bending the plate using the 3D model was calculated to analyse the intra-op time and cost-saving benefits.

For the 4 cases, the plate pre-bending times were 45, 40, 45 & 20 minutes (average 38.8 mins). The intra-op correction time to make small adjustments to the plate was 2 min/ case. 3 plates needed minor (3 degree) adjustment to fine-tune scapula spine contouring. 1 plate needed a 5 degree correction to fine-tune hand position. On average, the pre-bending of the plate saved approximately 38.8 mins intra-op/ case. These shorter anaesthetic and operating times equate to approximately $2586 saving/ case, given an estimate of $4000/hour of theatre costs.

We conclude that pre-bending plates around 3D-printed life-size models of an individual's shoulder girdle prior to surgery results in approximately 38.8 mins time saving intra-op when used in shoulder arthrodesis. This is a viable and effective technique that will ultimately result in significant operative time and financial savings.

Introduction

Patients undergoing a total knee arthroplasty (TKA) are now living longer and partaking in more active lifestyles. They expect a high level of post-operative function and long term durability of their implant.

Using electromyography (EMG) analysis helps further explain biomechanical findings by giving insight as to what is occurring at the level of the muscles. Normal biomechanics are not restored post-TKA as patients have reduced knee flexion and weakened quadriceps muscles compared to their healthy peers.

The trapeziometacarpal joint (TMCJ) is the most common hand joint affected by osteoarthritis (OA), and trapezium implant arthroplasty is a potential treatment for recalcitrant OA. This meta-analysis aimed to investigate the efficacy and safety of various trapezium implants as an interventional option for TMCJ OA. Web of Science, PubMed, Scopus, Google Scholar, and Cochrane library databases were searched for relevant studies up to May 2022. Preferred Reported Items for Systematic Review and Meta-Analysis guidelines were adhered to and registered on PROSPERO. The methodological quality was assessed by National Heart, Lung, and Blood Institute tools for observational studies and the Cochrane risk of bias tool. Subgroup analyses were performed on different replacement implants, the analysis was done via Open Meta-Analyst software and P values < 0.05 were considered statistically significant.

A total of 123 studies comprising 5752 patients were included. Total joint replacement (TJR) implants demonstrate greater significant improvements in visual analogue scale pain scores postoperatively. Interposition with partial trapezial resection implants was associated with the highest grip strength and highest reduction in the Disabilities of the Arm, Shoulder, and Hand score. Revision rates were highest in TJR (12.3%), and lowest in interposition with partial trapezial resection (6.2%).

Total joint replacement and interposition with partial trapezial resection implants improve pain, grip strength, and DASH scores more than other implant options. Future studies should focus on high-quality randomized clinical trials comparing different implants to accumulate higher quality evidence and more reliable conclusions.

Introduction: The mechanobiology and response of bone formation to strain under physiological loading is well established, however investigation into exceedingly soft scaffolds relative to cancellous bone is limited. In this study we designed and 3D printed mechanically-optimised low-stiffness implants, targeting specific strain ranges inducing bone formation and assessed their biological performance in a pre-clinical in vivo load-bearing tibial tuberosity advancement (TTA) model. The TTA model provides an attractive pre-clinical framework to investigate implant osseointegration within an uneven loading environment due to the dominating patellar tendon force.

A knee finite element model from ovine CT data was developed to determine physiological target strains from simulated TTA surgery. We 3D printed low-stiffness Ti wedge osteotomy implants with homogeneous stiffness of 0.8 GPa (Ti1), 0.6 GPa (Ti2) and a locally-optimised design with a 0.3 GPa cortex and soft 0.1 GPa core (Ti3), for implantation in a 12-week ovine tibial advancement osteotomy (9mm). We quantitatively assessed bone fusion, bone area, mineral apposition rate and bone formation rate.

Optimised Ti3 implants exhibited evenly high strains throughout, despite uneven wedge osteotomy loading. We demonstrated that higher strains above 3.75%, led to greater bone formation. Histomorphometry showed uniform bone ingrowthin optimised Ti3 compared to homogeneous designs (Ti1 and Ti2), and greater bone-implant contact. The greatest bone formation scores were seen in Ti3, followed by Ti2 and Ti1.

Results from our study indicate lower stiffness and higher strain ranges than normally achieved in Ti scaffolds stimulate early bone formation. By accounting for loading environments through rational design, implants can be optimised to improve uniform osseointegration. Design and 3D printing of exceedingly soft titanium orthopaedic implants enhance strain induced bone formation and have significant importance in future implant design for knee, hip arthroplasty and treatment of large load-bearing bone defects.

Introduction

The mobile-bearing (MB) total knee arthroplasty (TKA) design was introduced with the aim of reducing polyethylene wear and component loosening seen in the fixed-bearing (FB) design. A recent joint registry study has revealed increased risk for all-cause revision, but not revision for infection, in MB-TKA. We used the New Zealand Joint Registry (NZJR) to compare all-cause revision rates, and revision rates for aseptic loosening of MB-TKA compared with fixed bearing (FB) TKA.

Introduction

Management of Vancouver type B1 and C periprosthetic fractures in elderly patients requires fixation and an aim for early mobilisation but many techniques restrict weightbearing due to re-fracture risk. We present the clinical and radiographic outcomes of our technique of total femoral plating (TFP) to allow early weightbearing whilst reducing risk of re-fracture.

Clinically significant proximal junctional kyphosis (PJK) occurs in 20% of children treated with posterior distraction-based growth friendly surgery. In an effort to identify modifiable risk factors, it has been theorized biomechanically that low radius of curvature (ROC) implants (i.e., more curved rods) may increase post-operative thoracic kyphosis, and thus may pose a higher risk of developing PJK. We sought to test the hypothesis that EOS patients treated with low ROC (more curved rods) distraction-based treatment will have a greater risk of developing PJK as compared to those treated with high ROC (straighter) implants.

This is a retrospective review of prospectively collected data obtained from a multi-centre EOS database on children treated with rib-based distraction with minimum 2-year follow-up. Variables of interest included: implant ROC at index (220 mm or 500 mm), patient age, pre-operative scoliosis, pre-operative kyphosis, and scoliosis etiology. In the literature, PJK has been defined as clinically significant if revision surgery with superior extension of the upper instrumented vertebrae was performed.

In 148 scoliosis patients, there was a higher risk of clinically significant PJK with low ROC (more curved) rods (OR: 2.6 (95%CI 1.09-5.99), χ2 (1, n=148) = 4.8, p = 0.03). Patients had a mean pre-operative age of 5.3 years (4.6y 220 mm vs 6.2y 500 mm, p = 0.002). A logistic regression model was created with age as a confounding variable, but it was determined to be not significant (p = 0.6). Scoliosis etiologies included 52 neuromuscular, 52 congenital, 27 idiopathic, 17 syndromic with no significant differences in PJK risk between etiologies (p = 0.07). Overall, patients had pre-op scoliosis of 69° (67° 220mm vs 72° 500mm, p = 0.2), and kyphosis of 48° (45° 220mm vs 51° 500mm, p = 0.1). The change in thoracic kyphosis pre-operatively to final follow up (mean 4.0 ± 0.2 years) was higher in patients treated with 220 mm implants compared to 500 mm implants (220 mm: 7.5 ± 2.6° vs 500 mm: −4.0 ± 3.0°, p = 0.004).

Use of low ROC (more curved) posterior distraction implants is associated with a significantly greater increase in thoracic kyphosis which likely led to a higher risk of developing clinically-significant PJK in EOS patients.

OSSTEC is a pre-spin-out venture at Imperial College London seeking industry feedback on our orthopaedic implants which maintain bone quality in the long term. Existing orthopaedic implants provide successful treatment for knee osteoarthritis, however, they cause loss of bone quality over time, leading to more dangerous and expensive revision surgeries and high implant failure rates in young patients.

OSSTEC tibial implants stimulate healthy bone growth allowing simple primary revision surgery which will provide value for all stakeholders. This could allow existing orthopaedics manufacturers to capture high growth in existing and emerging markets while offering hospitals and surgeons a safer revision treatment for patients and a 35% annual saving on lifetime costs. For patients, our implant technology could mean additional years of quality life by revising patients to a primary TKA before full revision surgery.

Our implants use patent-filed additive manufacturing technology to restore a healthy mechanical environment in the proximal tibia; stimulating long term bone growth. Proven benefits of this technology include increased bone formation and osseointegration, shown in an animal model, and restoration of native load transfer, shown in a human cadaveric model.

This technology could help capture the large annual growth (24%) currently seen in the cementless knee reconstruction market, worth $1.2B. Furthermore, analysis suggests an additional market of currently untreated younger patients exists, worth £0.8B and growing by 18% annually. Making revision surgery and therefore treatment of younger patients easier would enable access to this market. We aim to offer improved patient treatment via B2B sales of implants to existing orthopaedic manufacturer partners, who would then provide them with instrumentation to hospitals and surgeons.

Existing implant materials provide good options for patient treatments, however OSSTEC's porous titanium structures offer unique competitive advantages; combining options for modular design, cementless fixation, initial bone fixation and crucially long term bone maintenance.

Speaking to surgeons across global markets shows that many surgeons are keen to pursue bone preserving surgeries and the use of porous implants. Furthermore, there is a growing demand to treat young patients (with 25% growth in patients younger than 65 over the past 10 years) and to use cementless knee treatments, where patient volume has doubled in the past 4 years and is following trends in hip treatments.

Our team includes engineers and consultant surgeons who have experience developing multiple orthopaedic implants which have treated over 200,000 patients. To date we have raised £175,000 for the research and development of these implants and we hope to gain insight from industry professionals before further development towards our aim to begin trials for regulatory approval in 2026.

OSSTEC implants provide a way to stimulate bone growth after surgery to reduce revision risk. We hope this could allow orthopaedic manufactures to explore high growth markets while meaning surgeons can treat younger patients in a cost effective way and add quality years to patients' lives.

Ti-6Al-4V is the most common alloy used for orthopaedic implants. Its popularity is due to low density, superior corrosion resistance, good osseointegration and lower elastic modulus when compared to other commonly used alloys such as CoCrMo and stainless steel. In fact, the use of Ti64 has even further increased lately since recent controversy around adverse local tissue reactions and implant failure related to taper corrosion of CoCrMo alloy. However, implants made from Ti64 can fail in some cases due to fatigue fracture, sometimes related to oxide induced stress corrosion cracking or hydrogen embrittlement, or preferential corrosion of the beta phase. Studies performed with Ti-6Al-4V do often not consider that the alloy itself may have a range of characteristics that can vary and could significantly impact the implant properties. These variations are related to the material microstructure which depends not only on chemical composition, but also the manufacturing process and subsequent heat treatments. Different microstructures can occur in implants made form wrought alloys, cast alloys, and more recently, additive manufactured (AM) alloys. Implant alloy microstructure drives mechanical and electrochemical properties. Therefore, this study aims to analyse the microstructure of Ti-6Al-4V alloy of additive manufactured and conventional retrieved orthopaedic implants such as acetabular cups, tibial trays, femoral stem and modular neck by means of electron backscatter diffraction (EBSD). Microstructural features of interest include grains shape and size, phase content and distribution, preferred grain orientation (texture), alloying elements distribution (homogenization) and presence of impurities. Additionally, we demonstrate the direct impact of different microstructural features on hardness. We analysed 17 conventional devices from 6 different manufacturers, 3 additive manufactured devices from 2 different manufactures and 1 control alloy (bar stock). The preliminary results showed that even though all implants have the same chemical composition, their microstructural characteristics vary broadly. Ti64 microstructure of conventional alloys could be categorized in 3 groups: equiaxed grains alloys (Fine and Coarse), bimodal alloys and dendritic alloys. The additive manufactured implants were classified in an additional group on its own which consists of a needle-like microstructures - similar to Widmanstätten patterns, Fig. 1, with a network of β phase along α phase grains. Furthermore, AM alloys exhibited residual grain boundaries from the original β grains from the early stage of the solidification process, Fig. 2. These characteristics may have implication on the fatigue and corrosion behaviour. In addition, it we observed inhomogeneous alloying element distribution in some cases, Fig. 3, especially for the additive manufactured alloys, which also may have consequences on corrosion behaviour. Finally, the hardness testing revealed that the implants with large grain size, such as AM alloys, exhibit low hardness values, as expected, but also the amount of beta phase correlated positively with lower hardness. Grain aspect ratio and beta phase grain size correlated positively with higher hardness. In summary, we found that common Ti64 implants can exhibit a broad variety of different alloy microstructures and the advent of AM alloys introduces an entirely new category. It is imperative to determine the ideal microstructure for specific applications.

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.