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.

Background

There is significant variation and inconsistencies in the current advice and information delivered to patients undergoing total hip replacement (THR). The aim of this study was to assess a locally developed web-based electronic resource system for patients undergoing total hip replacement (THR) surgery to see if this improves and standardises the content, structure, and delivery of information delivered to patients prior to and after surgery.

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

One unpredictable clinical risk with THA may be impingement of a metal cup rim against a metal femoral-neck, with concomitant release of metal particles. Our objective was to determine if metal debris could be one trigger for catastrophic MOM wear.

Introduction

Surgical site infection (SSI) remains a concern following total hip arthroplasty (THA). We aimed to identify risk factors for post-operative SSI in THA.

Many different designs of total hip arthroplasty (THA) with varying performance and cost are available. The identification of those which are the most cost-effective could allow significant cost-savings. We used an established Markov model to examine the cost effectiveness of five frequently used categories of THA which differed according to bearing surface and mode of fixation, using data from the National Joint Registry for England and Wales. Kaplan–Meier analyses of rates of revision for men and women were modelled with parametric distributions. Costs of devices were provided by the NHS Supply Chain and associated costs were taken from existing studies. Lifetime costs, lifetime quality-adjusted-life-years (QALYs) and the probability of a device being cost effective at a willingness to pay £20 000/QALY were included in the models.

The differences in QALYs between different categories of implant were extremely small (<  0.0039 QALYs for men or women over the patient’s lifetime) and differences in cost were also marginal (£2500 to £3000 in the same time period). As a result, the probability of any particular device being the most cost effective was very sensitive to small, plausible changes in quality of life estimates and cost.

Our results suggest that available evidence does not support recommending a particular device on cost effectiveness grounds alone. We would recommend that the choice of prosthesis should be determined by the rate of revision, local costs and the preferences of the surgeon and patient.

Cite this article: Bone Joint J 2015;97-B:449–57.

We reviewed the initial post-operative radiographs of the Trident acetabulum and identified a problem with seating of the metal-backed ceramic liner. We identified 117 hips in 113 patients who had undergone primary total hip replacement using the Trident shell with a metal-backed alumina liner. Of these, 19 (16.4%) were noted to have incomplete seating of the liner, as judged by plain anteroposterior and lateral radiographs. One case of complete liner dissociation necessitating early revision was not included in the prevalence figures. One mis-seated liner was revised in the early post-operative period and two that were initially incompletely seated were found on follow-up radiographs to have become correctly seated. There may be technical issues with regard to the implanting of this prosthesis of which surgeons should be aware. However, there is the distinct possibility that the Trident shell deforms upon implantation, thereby preventing complete seating of the liner.

Metal-on-metal (MOM) is a commonly used bearing notable for its ‘suction fit’ when lubricated. In this study, we examined the capacity for MOM bearings to protect against dislocation after total hip replacement (THR).

We undertook a clinical investigation to compare the rate of dislocation of MOM bearings with those of ceramic-on-polyethylene (COP) bearings and found that one MOM bearing dislocated in a series of 109 hips (0.9%) compared with nine of 145 hips (6.2%) in the COP group (p = 0.02).

We also performed an in vitro investigation comparing the peak forces generated during forced separation of the two bearings of the same dimensions at velocities from 1 to 50 cm/s. This revealed that the MOM bearing generated significant resistance to separation at all velocities (maximum mean 24 N), whereas the COP did not (maximum mean 1.9 N, p < 0.001). We conclude that MOM bearings are more stable to dislocation than COP bearings as a result of the interfacial forces provided by a thin, lubricating fluid.

A total of 110 total knee replacements (TKRs) was randomised to receive either a cemented or an uncemented prosthesis. Postoperative venography at five to seven days was used to compare the prevalence, site and size of deep-vein thrombosis (DVT). We also compared the findings with those of postoperative venography in a group of patients with cemented total hip replacements (THRs).

The total prevalence of DVT was significantly greater after uncemented (81%) than after cemented TKR (55%). Both knee groups had a significantly higher prevalence of DVT than in cemented hip replacements (32%). We found no difference in the proportion with proximal DVT in the three groups (14%, 15% and 16%). The median length of the thrombi was significantly greater after cemented (26.5 cm) than after uncemented TKR (11 cm) or after cemented THR (7 cm). This difference was mainly due to greater lengths of distal rather than proximal thrombi.

We conclude that the use of cement may affect the formation of DVT after joint replacement, but does not appear to lead to an increased incidence.