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.

Aims

Manual impaction, with a mallet and introducer, remains the standard method of installing cementless acetabular cups during total hip arthroplasty (THA). This study aims to quantify the accuracy and precision of manual impaction strikes during the seating of an acetabular component. This understanding aims to help improve impaction surgical techniques and inform the development of future technologies.

The trend towards more minimal access has led to a series of instruments being developed to enable adequate access for Direct Anterior Approach (DAA) for hip arthroplasty. These include longer levers, hooks attached to the operating table and a series of special attachments to the operating table to position the leg and apply traction where necessary. The forces applied in this way may be transmitted locally, damaging muscle used as a fulcrum, or the knee and ankle joints when torque has to be applied to the femur through a boot. The arthroplasty surgeon's aim is to minimise the forces applied to both bone and soft tissue during surgery.

We surmised that the forces needed for adequate access were related to the extent of the capsular and soft tissue releases, and that they could be measured and optimised. with the aim of minimising the forces applied to the tissues around the hip.

Eight fresh frozen specimens from pelvis to mid tibia from four cadavers were approached using the DAA. A 6-axis force/torque sensor and 6-axis motion tracking sensor were attached to a threaded rod securely fastened to the tibial and femoral diaphysis. The torque needed to provide first extension, then external rotation, adequate for hip arthroplasty were measured as the capsular structures were divided sequentially.

The Zona Orbicularis (ZO) and Ischiofemoral Ligament(IFL) contributed most of the resistance to both extension (4.0 and 3.1Nm) and external rotation torque (5.8 and 3.9Nm). The contributions of the conjoint tendon (1.5 and 2.4Nm) and piriformis (1.2 and 2.3Nm) were substantially smaller.

By releasing the Zona Orbicularis and Ischiofemoral Ligament, the torque needed to deliver the femur for hip arthroplasty could be reduced to less than the torque needed to open a jar (2.9–5.5Nm).

Superior teamwork in the operating theatre is associated with improved technical performance and clinical outcomes. Yet modern rota patterns, workforce shortages, and increasing complexity of surgery, means that there is less familiarity between staff and the required choreography. Immersive Virtual Reality (iVR) can successfully train surgical staff individually, however iVR team training has yet to be investigated. We aimed to design a multiplayer iVR platform for anterior approach total hip arthroplasty (AA-THA) and assess if multiplayer iVR training was superior to single player training for acquisition of both technical and non-technical skills.

An iVR platform with choreographed roles for the surgeon and scrub nurse was developed using Cognitive Task Analysis. Forty participants were randomised to individual or team iVR training. Individually- trained participants practiced alongside virtual avatar counterparts, whilst teams trained live in pairs. Both groups underwent five iVR training sessions over 6-weeks. Subsequently, they underwent a real-life assessment in which they performed AA-THA on a high-fidelity model with real equipment in a simulated theatre. Teams performed together and individually trained participants were randomly paired up. Videos were marked by two blinded assessors recording the NOTSS, NOTECHS II and SPLINTS scores - validated technical and non-technical scores assessing surgeon and scrub nurse skills. Secondary outcomes were procedure time and number of technical errors.

Teams outperformed individually trained participants for non-technical skills in the real-world assessment (NOTSS 13.1 ± 1.5 vs 10.6 ± 1.6, p =0.002, NOTECHS-II score 51.7 ± 5.5 vs 42.3 ± 5.6, p=0.001 and SPLINTS 10 ± 1.2 vs 7.9 ± 1.6, p = 0.004). They completed the assessment 28.1% faster (27.2 minutes ± 5.5 vs 41.8 ±8.9, p<0.001), and made fewer than half the number of technical errors (10.4 ± 6.1 vs 22.6 ± 5.4, p<0.001).

Multiplayer training leads to faster surgery with fewer technical errors and the development of superior non-technical skills for anterior approach total hip arthroplasty. The convention of surgeons and nurses training separately, but undertaking real complex surgery together, can be supplanted by team training, delivered through immersive virtual reality.

Superior team performance in surgery leads to fewer technical errors, reduced mortality, and improved patient outcomes. Scrub nurses are a pivotal part of this team, however they have very little structured training, leading to high levels of stress, low confidence, inefficiency, and potential for harm. Immersive virtual reality (iVR) simulation has demonstrated excellent efficacy in training surgeons. We tested the efficacy of an iVR curriculum for training scrub nurses in performing their role in an anterior approach total hip arthroplasty (AA-THA).

Sixty nursing students were included in this study and randomised in a 1:1 ratio to learning the scrub nurse role for an AA-THA using either conventional training or iVR. The training was derived through expert consensus with senior surgeons, scrub nurses and industry reps. Conventional training consisted of a 1-hour seminar and 2 hours of e-learning where participants were taught the equipment and sequence of steps. The iVR training involved 3 separate hour-long sessions where participants performed the scrub nurse role with an avatar surgeon in a virtual operation. The primary outcome was their performance in a physical world practical objective assessment with real equipment. Data were confirmed parametric using the Shapiro-Wilk test and means compared using the independent samples student's t-test.

53 participants successfully completed the study (26 iVR, 27 conventional) with a mean age of 31±9 years. There were no significant differences in baseline characteristics or baseline knowledge test scores between the two groups (p>0.05). The iVR group significantly outperformed the conventionally trained group in the real-world assessment, scoring 66.9±17.9% vs 41.3±16.7%, p<0.0001.

iVR is an easily accessible, low cost training modality which could be integrated into scrub nursing curricula to address the current shortfall in training. Prolonged operating times are strongly associated with an increased risk of developing serious complications. By upskilling scrub nurses, operations may proceed more efficiently which in turn may improve patient safety.

Patients may be able to return to higher level activities following hip arthroplasty with modern techniques and prostheses, but the Oxford hip score, the standard PROM used by the NJS exhibits severe skew and kurtosis. The commonest score is 48/48. Most patients score above 40 preventing any discrimination between approaches or prostheses. We therefore sought both subjective and objective metrics which were relevant and valid without skew or high kurtosis in postoperative patients. The Metabolic Equivalent of Task (MET) reports energy usage in kcal/min burnt across a range of activities, condensed into a score of 0–25. A MET over 8 is considered ‘conditioning exercise’ tethered to life expectancy. A 2 point difference in average MET is considered a clinically relevant difference. Walking speed is a simple valid metric tethered to life expectancy, with a 0.1m/sec difference in walking speed equates to a clinically important difference.

Oxford Hip Score (OHS), and the MET were prospectively recorded in 221 primary hip arthroplasty procedures pre-operatively and at 1-year using a web based application. Pre and postoperative Gait analysis was undertaken on a subgroup of 34 patients, in comparison with age and sex matched controls.

Post-operatively, the OHS demonstrated significant skewed distributions with ceiling effects of 41% scoring 48/48. The MET was normally distributed around a mean of 10.3, with a standard deviation of 3.8 and no ceiling effect. Walking speed was normally distributed around a mean of 1.8m/sec, with a standard deviation was 0.15 m/sec

The MET is a simple patient reported score, which is normally distributed in patients following hip arthroplasty, around a mean of 10.3 with a standard deviation of 3.8. This valid activity metric correlates well with fast walking speed. This is also normally distributed with a standard deviation of over 0.1m/sec confirming low kurtosis. These simple measures have face validity: undertaking less active pastimes and being unable to keep up with other walkers are obviously inadvisable. The normal kurtosis of these metrics suggest that they may able to detect clinically relevant differences in outcome which are undetectable with commonly used PROMs. For surgeons developing less invasive approaches or using novel stems, these measures may detect clinically important improvements undetectable by the Oxford Hip Score.

This study investigates the use of the Metabolic Equivalent of Task (MET) score in a hip arthroplasty population and its ability to capture additional benefit beyond the maximum Oxford Hip Score (OHS).

OHS, EuroQol-5D index (EQ-5D), and the MET were prospectively recorded in 221 primary hip arthroplasty procedures pre-operatively and at 1-year. The distribution was examined reporting the presence of ceiling & floor effects. Validity was assessed correlating the MET with the other scores using Spearman's rank and determining responsiveness using the standardised response mean (SRM). A subgroup of 93 patients scoring 48/48 on the OHS were analysed by age group, sex, BMI and pre-operative MET using the other two metrics to determine if differences could be established despite all scoring identically on the OHS.

117 total hip and 104 hip resurfacing arthroplasty operations were included. Mean age was 59.4 ± 11.3. Post-operatively the OHS and EQ-5D demonstrate significant negatively skewed distributions with ceiling effects of 41% and 53%, respectively. The MET was normally distributed post-operatively with no ceiling effect. Weak-moderate but statistically significant correlations were found between the MET and the other two metrics both pre & post-operatively. Responsiveness was excellent, SRM for OHS: 2.01, EQ-5D: 1.06 and MET: 1.17. In the 48/48 scoring subgroup, no differences were found comparing groups with the EQ-5D, however significantly higher MET scores were demonstrated for patients aged <60 (12.7 vs 10.6, p=0.008), male patients (12.5 vs 10.8, p=0.024) and those with pre-operative MET scores >6 (12.6 vs 11.0, p=0.040).

The MET is normally distributed in patients following hip arthroplasty, recording levels of activity which are undetectable using the OHS. As a simple, valid activity metric, it should be considered in addition to conventional PROMs in order to capture the entire benefit experienced following hip arthroplasty.

Background

For total hip arthroplasty (THA), cognitive training prior to performing real surgery may be an effective adjunct alongside simulation to shorten the learning curve. This study sought to create a cognitive training tool to perform direct anterior approach THA, validated by expert surgeons; and test its use as a training tool compared to conventional material.

Background

Virtual Reality (VR) uses headsets and motion-tracked controllers so surgeons can perform simulated total hip arthroplasty (THA) in a fully-immersive, interactive 3D operating theatre. The aim of this study was to investigate the effect of laboratory-based VR training on the ability of surgical trainees to perform direct anterior approach THA on cadavers.

The hip joint capsular ligaments (CL) passively restrain extreme range of motion (ROM) by wrapping around the native femoral head, and protect against impingement, edge loading wear and dislocation. This study compared how ligament function was affected by device (hip resurfacing arthroplasty, HRA; dual mobility total hip arthroplasty, DM-THA; and conventional THA, C-THA), with and without CL repair. It was hypothesized that ligament function would only be preserved when native anatomy was preserved: with restoration of head-size (HRA or DM-THA) and repair.

Eight normal male cadaveric hips were skeletonised, retaining the hip capsule. CL function was quantified by measuring ROM by internally (IR) and externally rotating (ER) the hip in six functional positions, ranging from full extension with abduction to full flexion with adduction (squatting). Native ROM was compared to ROM after posterior capsulotomy and HRA, and C-THA and DM-THA, before and after surgical CL repair.

ROM increased most following C-THA (max 62°), then DM-THA (max 40°), then HRA (max 19°), indicating later engagement of the capsule and reduced biomechanical function with smaller head-size. Dislocations also occurred in squatting after C-THA and DM-THA. CL-repair following HRA restored ROM to the native hip (max 8°). CL-repair following DM-THA reduced ROM hypermobility in flexed positions only and prevented dislocation (max 36°). CL-repair following C-THA did not reduce ROM or prevent dislocation.

When HRA was combined with repair, native anatomy was preserved and ligament function was restored. For DM-THA with repair, ligament function depended on the movement of the mobile bearing resulting in near-native function in some positions, but increased ROM when ligaments were unable to wrap around the head/neck. Following C-THA, the reduced head-size resulted in inferior capsular mechanics in all positions as the ligaments remained slack, irrespective of repair.

Choosing devices with anatomic head-sizes (resurfacing or dual-mobility) and repairing the capsular ligaments may protect against instability in the early postoperative period.

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.

Introduction

Outcomes following large joint arthroplasty are influenced by the accuracy of implant placement. Patient specific (PS) technology has been used in knee arthroplasty surgery however, its application in total hip arthroplasty remains relatively unexplored.

We measured the orientation of the acetabular and femoral components in 45 patients (33 men, 12 women) with a mean age of 53.4 years (30 to 74) who had undergone revision of metal-on-metal hip resurfacings. Three-dimensional CT was used to measure the inclination and version of the acetabular component, femoral version and the horizontal femoral offset, and the linear wear of the removed acetabular components was measured using a roundness machine.

We found that acetabular version and combined version of the acetabular and femoral components were weakly positively correlated with the rate of wear. The acetabular inclination angle was strongly positively correlated with the rate of wear. Femoral version was weakly negatively correlated with the rate of wear. Application of a threshold of > 5 μm/year for the rate of wear in order to separate the revisions into low or high wearing groups showed that more high wearing components were implanted outside Lewinnek’s safe zone, but that this was mainly due to the inclination of the acetabular component, which was the only parameter that significantly differed between the groups.

We were unable to show that excess version of the acetabular component alone or combined with femoral version was associated with an increase in the rate of wear based on our assessment of version using CT.

We carried out metal artefact-reduction MRI, three-dimensional CT measurement of the position of the component and inductively-coupled plasma mass spectrometry analysis of cobalt and chromium levels in whole blood on 26 patients with unexplained pain following metal-on-metal resurfacing arthroplasty.

MRI showed periprosthetic lesions around 16 hips, with 14 collections of fluid and two soft-tissue masses. The lesions were seen in both men and women and in symptomatic and asymptomatic hips. Using three-dimensional CT, the median inclination of the acetabular component was found to be 55° and its positioning was outside the Lewinnek safe zone in 13 of 16 cases. Using inductively-coupled plasma mass spectrometry, the levels of blood metal ions tended to be higher in painful compared with well-functioning metal-on-metal hips.

These three clinically useful investigations can help to determine the cause of failure of the implant, predict the need for future revision and aid the choice of revision prostheses.

We have investigated nine patients with cemented Furlong (JRI, London, UK) titanium hip replacements who presented with early pain despite a well-fixed, aseptic prosthesis. All were followed up clinically and radiologically at regular intervals. Pain was located in the thigh and was worse at night. Radiographs showed cortical hypertrophy of the femur around the tip of the stem. Eight of the nine patients subsequently required single-stage revision using an uncemented prosthesis, which relieved the pain. At revision, the pH of the tip of the stem was found to be highly acidic with macroscopic evidence of corrosion consisting of multiple layers of titanium oxides when studied by X-ray dispersive analysis. Cemented titanium implants have a potential for crevice corrosion leading to cortical hypertrophy and intractable pain.