Introduction

The incidences of fragility fractures, often because of osteoporosis, are increasing. Research has moved towards bioresorbable scaffolds that provide temporary mechanical stability and promote osteogenesis. This research aims to fabricate a 3D printed composite Poly (l-lactic-co-glycolic acid)-strontium doped tricalcium phosphate (PLGA-SrTCP) scaffold and evaluate in an in vitro co culture study containing osteoporotic donor cells.

A ceramic-on-ceramic hip resurfacing implant (cHRA) was developed and introduced in an MHRA-approved clinical investigation to provide a non metallic alternative hip resurfacing product. This study aimed to examine function and physical activity levels of patients with a cHRA implant using subjective and objective measures both before and 12 months following surgery in comparison with age and gender matched healthy controls.

Eighty-two unilateral cHRA patients consented to this study as part of a larger prospective, non-randomised, clinical investigation. In addition to their patient reported outcome measures (PROMs), self- reported measures of physical activity levels and gait analysis were undertaken both pre- operatively (1.5 weeks) and post operatively (52 weeks). This data was then compared to data from a group of 43 age gender and BMI matched group of healthy controls. Kinetics and kinematics were recorded using an instrumented treadmill and 3D Motion Capture. Statistical parametric mapping was used for analysis.

cHRA improved the median Harris Hip Score from 63 to 100, Oxford Hip score from 27 to 48 and the MET from 5.7 to 10.3. cHRA improved top walking speed (5.75km vs 7.27km/hr), achieved a more symmetrical ground reaction force profile, (Symmetry Index value: 10.6% vs 0.9%) and increased hip range of motion (ROM) (31.7° vs 45.9°). Postoperative data was not statistically distinguishable from the healthy controls in any domain.

This gait study sought to document the function of a novel ceramic hip resurfacing, using those features of gait commonly used to describe the shortcomings of hip arthroplasty. These features were captured before and 12 months following surgery. Preoperatively the gait patterns were typical for OA patients, while at 1 year postoperatively, this selected group of patients had gait patterns that were hard to distinguish from healthy controls despite an extended posterior approach. Applications for regulatory approval have been submitted.

Abstract

Aims

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.

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 in vivo and ex vivo bone formation.

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.

Introduction

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.

Introduction

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.

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.

Introduction

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.

Background & Objectives: Osteoporosis is one of the most prevalent bone diseases worldwide with fractures its major clinical consequence. Studies on the effect of osteoporosis on fracture repair are contradictory and although it might be expected for fracture repair to be delayed in osteoporotic individuals, a definitive answer still eludes us. Subsequently, the aim of this study was to attempt to clarify any such effect.

Methods: Osteoporosis was induced in 53 female Sprague-Dawley rats by ovariectomy (OVX) at 3 months. A femoral fracture was produced in these animals 12 weeks later {OVX+Fracture group (OVX+F)}. A control group received the fracture only group (F) at 6 months. The fracture consisted of an open osteotomy held with a unilateral external fixator. Outcome measures include histology, motion detector analysis, pQCT, biomechanical strength testing (BST) and digital radiography. Digital radiographs were taken at time of OVX, fracture (confirming satisfactory reduction) and sacrifice from which relative bone density (BMD) measurements were calculated.

Results: OVX+F animals were significantly heavier than F animals at fracture and sacrifice (p< 0.001 for both) and moved significantly less in days 1-4 (p=0.032) and 5-9 (p=0.020) post-fracture. Relative BMD measured in distal femur at fracture and sacrifice was significantly greater in F group (p< 0.001 for both). Furthermore, there was a significant decrease in relative BMD from fracture to sacrifice in OVX+F group (p< 0.001). pQCT showed a significantly greater total BMD {contralateral (p=0.021) and fractured femora (p< 0.001)} and trabecular BMD (p< 0.001 both limbs) in the distal femur of the F group. Histologically, no statistical differences were found, however, the F group generally displayed the most advanced repair. In the contralateral limb, the F group had significantly greater load to failure at 6 (p=0.026) and 8 (p=0.042) weeks and was significantly stiffer at 8 weeks (p=0.050). In the fractured leg, stiffness was significantly greater in the F group at 8 weeks (p=0.001).

Conclusion: OVX was linked to increased body weight, decreased motion, decreased BMD (with particular loss in trabecular BMD), and reduced mechanical properties. OVX did not have a significant effect on fracture healing and although there was no reduction in BMD at the fracture site, histology and reduced stiffness suggest it was delayed.

Background & Objectives: Statins have been shown to stimulate bone formation in vivo and in vitro in rodent models1 generating interest in the possibility that they may be useful therapeutic agents for osteoporosis. The major clinical consequence of osteoporosis are fractures that occur and although there is no firm evidence, there is a perceived associated delay in fracture repair. We examined the influence of atorvastatin on fracture repair in an ovariectomised rat fracture model.

Methods: 126 Sprague-Dawley rats had an ovariectomy (OVX) at three months and a femoral fracture (F) at six months. The fracture consisted of an open osteotomy held with an external fixator. All animals were randomly assigned into groups 1. OVX+F and early atorvastatin; 2. OVX+F and late atorvastatin; 3. OVX+F. Atorvas-tatin (5mg/kg) was given daily by oral gavage for three months in-group 1 between OVX and fracture and from time of fracture to sacrifice in-group 2. Outcome measures were histology, peripheral quantitative computed tomography (pQCT), biomechanical strength testing (BST) and digital radiography. Digital radiographs were taken at time of OVX, fracture (confirming satisfactory reduction) and sacrifice from which relative bone density (BMD) measurements were calculated.

Results: Non-statin treated animals moved significantly more in 4 days post-fracture (p=0.015), had signifi-cantly more relative (p=0.037) and total BMD (distal femur) than statin treated (p=0.040, early and p=0.036, late treatment). Total BMD at the fracture site was also significantly greater in the OVX+F than the late statin group (p=0.047) while in the adjacent site of the con-tralateral limb, the early statin group had significantly more (p=0.018) than the late statin group. However no differences were found between the early statin and OVX+F groups. Histologically, the rate of repair increased significantly in early statin (p=0.013) and OVX+F (p=0.011) groups. BST data showed no signifi-cant difference in stiffness at six or eight weeks.

Conclusion: Fractures healed in all three groups. Statins did not prevent OVX induced bone loss. Initial evidence suggests that early statin treatment may have a positive effect on early fracture, as shown by x-ray analysis and histology, however this effect was lost by week 8. Overall the evidence suggests that atorvastatin may have impaired fracture repair, particularly with late administration (relative BMD and pQCT results).

Introduction: In the 1970’s, ‘viscosupplementation’ with hyaluronan was proposed as a potential treatment for OA with the idea that it would improve joint lubrication. However, despite studies showing its ability to reduce pain, the fact that the resident time within a joint (48 hours) is much less than its clinical effect (several months) along with pharmacological effects on chondroctyes and synoviocytes has confirmed that injected hyaluronan acts as a pharmaceutical rather than as a lubricant as originally thought. In this regard, the effects of inert synthetic lubricants on arthritic joints have not previously been adequately investigated.

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.

Materials & Methods: Osteoarthritic changes were initiated in the hind knee joint of 12 adult male Dunkin-Hartley guinea-pigs by excision of the medial meniscus and anterior cruciate ligament.

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.

Results: All guinea-pigs remained healthy and mobile throughout the study.

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.

Discussion: This study has confirmed that inert synthetic perfluoroalkylether lubricants can remain in the articular space for prolonged periods and inhibit the development of osteoarthritis without initiating an inflammatory response. Synthetic lubricants such as PFAE16350 warrant further investigation for potential use in osteoarthritis.

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.