In Ireland and the United Kingdom, there were 22 deaths as a direct result of blood transfusion during the period October 1996 to September 1998. Added to this mortality, there were 366 cases of complications directly related to blood transfusion.

With the introduction of a Haemovigilance Nurse, changing surgical personnel and an increased public awareness of the potential hazards of transfusion, we were anxious to review whether transfusion rates have changed in our Regional Orthopaedic Centre for the period January 1999 to July 2000

All patients undergoing primary or revision arthroplasty in our Regional Orthopaedic Unit during the study period were retrospectively reviewed.

459 primary or revision arthroplasties were performed in the study period. Prior to the introduction of a haemovigilance Nurse, from the period January 1999 to October 1999, transfusion rates for primary arthroplasties averaged 1.41 units/patient with 74% of patients being transfused. After the introduction of a haemovigilance Nurse, from November 1999 to July 2000, transfusion rates for primary arthroplasties averaged 0.51 units/patient, with 31% of patients being transfused.

Prior to the introduction of a haemovigilance Nurse revision arthroplasties averaged 2.5 units/patient, with 100% of patients being transfused. After the introduction of the haemovigilance Nurse transfusion averaged 1.2 units/patient, with 62% of patients being transfused.

There was a statistically significant difference between transfusion rates prior to the introduction of a Haemovigilance Nurse and new surgical personnel and the period after their introduction (p< 0.005).

In the current climate post the Finlay Tribunal and the resultant increased public awareness, transfusing a patient without justifiable cause is no longer acceptable.

Patients in this unit are now transfused according to clinical needs and accurate measurement of intra-operative and post-operative blood loss, compared to their calculated maximum allowed blood loss (MABL). The changing transfusion rates seen in our Unit correspond to the introduction of a Haemovigilance Nurse and a change in surgical personnel. Our new transfusion protocol is working well without compromising patient care.

Aim: To audit blood transfusion practice in primary total hip arthroplasty (THA) and primary total knee arthroplasty (TKA) after introduction of more stringent blood transfusion criteria.

Methods: A retrospective survey was carried out for all THR and TKR. Data was collected over a period of four months with a blood transfusion criteria of haemoglobin (Hb) concentration of 8.0 g/dl and below. This was compared against a three month period after the reduction in the blood transfusion criteria to a Hb concentration of 7.0 g/dl and below. An analysis of all pre-operative and post-operative (day-2 post-op) Hb concentrations was performed. The post-transfusion Hb concentration was recorded 1-day post transfusion.

Results: A total 539 TKA and 521 THA were performed. Following the new blood transfusion protocol the rate of blood transfusion was significantly reduced from 9.4% to 3.6% for TKA, and from 28% to 12.8% for THA.

Conclusion: A significant reduction in transfusion rates is achieved in TKA and THA by introduction of a Hb concentration 7.0 g/dl as a trigger for blood transfusion. This new trigger is based on the current body of evidence available and is integrated in to well defined care pathway. A 50% reduction in donated blood is predicted in the UK in 2007 if vCJD testing is enforced. We feel early redressing of blood transfusion practice in the UK is advised if we are to avoid a catastrophic reduction in our TKA and THA capacity.

Extended patient waiting lists for assessment and treatment are widely reported for planned elective joint replacement surgery. The development of regionally based Elective Orthopaedic Centres, separate from units that provide acute, urgent or trauma care has been suggested as one solution to provide protected capacity and patient pathways. These centres will adopt protocolised care to allow high volume activity and increased day-case care. We report the plan to establish a new elective orthopaedic centre serving a population of 2.4 million people. A census conducted in 2022 identified that 15000 patients were awaiting joint replacement surgery with predictions for further increases in waiting times. The principle of care will be to offer routine primary arthroplasty surgery for low risk (ASA 1 and 2) patients at a new regional centre. Pre-operative assessment and preparation will be undertaken digitally, virtually and/or in person at local centres close to the where patients live. This requires new and integrated pathways and ways of working. Predicting which patients will require perioperative transfusion of blood products is an important safety and quality consideration for new pathways. We reviewed all cases of hip and knee arthroplasty surgery conducted at our centre over a 12-month period and identified pre-operative patient related predictive factors to allow us to predict the need for the perioperative transfusion of blood products. We examined patient sex, age, pre-operative haemaglobin and platelet count, use of anti-coagulants, weight and body mass index to allow us to construct the Imperial blood transfusion tool. We have used the results of our study and the transfusion tool to propose the patient pathway for the new regional elective orthopaedic centre which we present

Aims. Elective orthopaedic services have had to adapt to significant system-wide pressures since the emergence of COVID-19 in December 2019. Length of stay is often recognized as a key marker of quality of care in patients undergoing arthroplasty. Expeditious discharge is key in establishing early rehabilitation and in reducing infection risk, both procedure-related and from COVID-19. The primary aim was to determine the effects of the COVID-19 pandemic length of stay following hip and knee arthroplasty at a high-volume, elective orthopaedic centre. Methods. A retrospective cohort study was performed. Patients undergoing primary or revision hip or knee arthroplasty over a six-month period, from 1 July to 31 December 2020, were compared to the same period in 2019 before the COVID-19 pandemic. Demographic data, American Society of Anesthesiologists (ASA) grade, wait to surgery, COVID-19 status, and length of hospital stay were recorded. Results. A total of 1,311 patients underwent hip or knee arthroplasty in the six-month period following recommencement of elective services in 2020 compared to 1,527 patients the year before. Waiting time to surgery increased in post-COVID-19 group (137 days vs 78; p < 0.001). Length of stay also significantly increased (0.49 days; p < 0.001) despite no difference in age or ASA grade. There were no cases of postoperative COVID-19 infection. Conclusion. Time to surgery and length of hospital stay were significantly higher following recommencement of elective orthopaedic services in the latter part of 2020 in comparison to a similar patient cohort from the year before. Longer waiting times may have contributed to the clinical and radiological deterioration of arthritis and general musculoskeletal conditioning, which may in turn have affected immediate postoperative rehabilitation and mobilization, as well as increasing hospital stay. Cite this article: Bone Jt Open 2021;2(8):655–660

Aims. To establish the cost of primary hip (THR) and knee (TKR) arthroplasty in an elective orthopaedic centre in the UK and to compare it with current government reimbursement to NHS hospitals and the costs in North America. Methods. In 2004 an elective orthopaedic centre was set up in South West London which performs mainly primary lower limb arthroplasty. We used a retrospective analysis of financial statements from September 2004-June 2005 inclusive to establish operative costs (including implant), perioperative costs and post-operative costs until discharge. Results. A total of 691 THRs and 897 TKRs were performed during this period accounting for 76% of the workload. Average post-operative stay was 6.5 days for TKRs and 5.7 for THRs. Average cost for a TKR was £6651 and for a THR £5990. Costs are favourable compared with our American colleagues and similar to our Canadian colleagues. Reimbursement in the NHS was set up in 2003-4 by the DH in the form of national tariffs. Our costs are similar to these reimbursements. We question the ability of general NHS hospitals in the UK to perform at these levels and prices for three reasons. Firstly, our high volume of joint replacement activity has enabled us to negotiate the most favourable implant prices in the UK. Secondly, length of stay in our unit is approximately 60% of national average. Thirdly, our unit is run without many of the infrastructure costs of a general hospital as well as the cost incurred by training junior staff and research and development. Conclusion. Our elective-only orthopaedic centre provides a cost effective way of performing primary arthroplasty surgery while maintaining high standards of care and twenty-four hour intensive care cover. We believe this cost effectiveness may be unachievable in general NHS hospitals in the UK

Abstract. Introduction. In revision knee arthroplasty, rotating hinge implants (RHK) have been considered to result in higher complication rates and lower survivorship when compared to constrained condylar implants (CCK). The aims of this study were to compare patient reported outcome measures (PROMs), complication rates and survivorship of RHK and CCK used in revision arthroplasty at a single, high volume elective orthopaedic centre with previously validated bespoke database. Methodology. One hundred and eight patients who underwent revision knee arthroplasty with either CCK or RHK and matched our inclusion criteria were identified. EQ5D, Health State and Oxford Knee Scores were collected pre-operatively and at 1 year post-operatively. Complication data was collected at 6 weeks, 6 months, 1 year and 2 years post-operatively. NJR data was interrogated, in addition to our own database, to investigate implant survival. Results. There was no statistically significant difference between RHK and CCK in implant survival at two to twelve years of follow up. In addition, we observed no statistically significant difference in the PROMs scores and complication rates of the two implants. Conclusion. This study shows that both the RHK and CCK remain viable options in revision arthroplasty, the implant survival and complication rate were comparable. We recommend prospective randomised control trials with long-term follow up to further investigate the use of CCK and RHK implants in revision knee arthroplasty

Introduction and Objective. Postoperative pain control in shoulder surgery is challenging even in arthroscopic procedures. Acute postoperative pain can last up to 48hrs despite using multimodal analgesia. Different techniques have been used to control acute pain following shoulder surgery. The most common technique currently used in shoulder surgery at the elective orthopaedic centre in Leeds is a combination of general anaesthetic (GA) and interscalene block (ISB). ISB maybe very effective, however, carries many risks and potential side effects such as brachial plexus injury and paralysis of the vagus and laryngeal recurrent nerves as well as cervical sympathetic nerve and pneumothorax. ISB can also be associated with higher incidence of neurological deficit compared to other peripheral nerve blocks; up to 14% at 10 days in some cases. As such we decided to examine the use of ISB for achieving pain control in our elective unit. Materials and Methods. A prospective consecutive series of 217 patients undergoing shoulder surgery were studied. These were grouped into 10 groups. All procedures were arthroscopic apart from shoulder arthroplasty procedures such as hemiarthroplasty and total shoulder replacements (TSRs). The choice of regional anaesthesia was ISB with GA as standard practice. Visual analogue scores (VAS) at 0hrs, 1hr, 2hrs, 4hrs and 6hrs; and total opiates intake were recorded. A one-way single factor ANOVA was used as preferred statistical analytical method to determine whether there is a difference in VAS scores and total opiates intake amongst the groups. Postoperative analgesics were used for pain relief, although these were not standardised. Results. In total shoulder replacement group, although the RSR group used more morphine on average compared to the ASR group (Mean morphine intake 6.5mg vs 3mg), this was not statistically significant (F<Fcrit; p value= 0.19). When comparing all the arthroplasty groups, the difference in mean morphine intake was also statistically not significant (F<Fcrit; p value=0.24). However, when comparing all 10 groups’ morphine intake there was a statistically significant difference amongst these groups (F>F crit; p value=0.03). Interestingly, there was a statistically significant difference in VAS at 0hrs (F>Fcrit p value=0.01); 1hrs (F>Fcrit; p value=0.00), and at 6hrs (F>Fcrit; p value=0.02) when comparing all 10 groups. Conclusions. ISB is an effective technique in achieving pain control in shoulder surgery; however, there are still variations in analgesic needs amongst groups and the use of alternative techniques should be thus explored. A future prospective study looking at acute pain for a longer period of time after shoulder surgery would explore the effectiveness of ISB in achieving pain control consistent with rehabilitation requirements

Aim: Our aim was to determine the in-hospital costs of total hip replacement (THR) and total knee replacement (TKR), and compare them to their reimbursement under the national tariff system and to our North American colleagues. Methods: In 2004 an elective orthopaedic centre was set up in South West London which performs mainly primary lower limb arthroplasty. We used a retrospective analysis of financial statements from September 2004- December 2005 inclusive to establish operative costs (including implant), perioperative costs and post operative costs until discharge. Results: A consecutive series of 1538 primary TKR patients (mean age = 72.2) and 1118 primary THR patients (mean age = 70.8) was studied from September 2004 to December 2005 accounting for 88% of the workload. Average post operative stay was 6.5 days for TKRs and 5.7 for THRs and 66% of the patients were ASA grade III or over. The cost including implant of a THR was £6054, and for a TKR it was £6499. After adjustment to allow direct comparison to tariff, our THR cost is 2.3% less than and 1.0% more than the 2004/5 and 2005/6 tariffs respectively. Our adjusted TKR cost is 5.0 % and 4.2% less than the 2004/5 and 2005/6 tariffs respectively. Our cemented and uncemented THR costs are 8.0% less than and 6.6% more than their respective tariffs introduced for the first time in 2005/6. Overall there is no large discrepancy between our THR/TKR costs and tariff reimbursements. Discussion: Although in our unit our costs are similar to the re-imbursements used in the UK, we question the ability of general NHS hospitals in the UK to perform at these levels and prices for three reasons. Firstly, our high volume of joint replacement activity has enabled us to negotiate the most favourable implant prices in the UK. Secondly, length of stay in our unit is approximately 60% of national average. Thirdly, our unit is run without many of the infrastructure costs of a general hospital as well as the cost incurred by training junior staff and research and development. Costs were also found to be favourable compared with our American colleagues and similar to our Canadian colleagues. Conclusion: Our elective only orthopaedic centre provides a cost effect way of performing primary arthroplasty surgery while maintaining high standards of care and twenty-four hour intensive care cover. We believe this cost effectiveness may be unachievable in general NHS hospitals in the UK

The treatment of massive chronic tears is problematic. The re-tear rate following surgery for extensive cuff tears remains high, and there is little consensus regarding optimum treatment. To investigate the outcome of a cohort of patients who had open repair of an extensive cuff tear using the Leeds Kuff patch as an augment. A retrospective cohort study of consecutive patients with a massive cuff tear who had surgery in our regional elective orthopaedic centre over a two year period from January 2015 to Dec 2016. All patients followed identical rehabilitation protocols, supervised by physiotherapists with an interest in the shoulder. Outcomes assessment was undertaken at a minimum of 12 months by a registrar or physiotherapist who was not part of the treating team. Pre-op data collection included; range of motion, pain score, Oxford shoulder score (OSS), assessment of muscle atrophy on MRI. Data collection was completed in 15 patients. The mean age was 62 yrs (56 – 75). The mean pre-op OSS was 22, improving to a mean of 43. The range of motion and pain score improved. There were no intra-operative complications. One patient required a second surgery for evacuation of a haematoma at 10 days post op. One patient had an obvious re-tear at 4 months. Open rotator cuff repair with synthetic Kuff patch augmentation for chronic degenerative tears appears worthwhile when assessed at 12 months and they continuous to improve even at 18 months. This treatment method may be a useful option for patients > 70 years old

Background. In the United Kingdom (UK), the fastest growing population demographic is the over 85 years of age, but despite this, outcomes achieved in the octogenarian population with a Unicompartmental Knee Replacement (UKR) are underrepresented in the literature. The Elective Orthopaedic Centre, Epsom, has an established patient reported outcome measures (PROMs) programme into which all patients are routinely enrolled. We aim to investigate the outcome of medial UKR using the oxford phase 3 implant in octogenarians. Methods. We retrospectively reviewed our database for patients aged 60–89 years, who underwent a medial unicompartmental Knee Replacement (UKR) using the oxford phase 3 implant, between June 2007-December 2012 (N=395). The patients were stratified into 3 groups based on age, 60–69 (N=188), 70–79(N=149), and 80–89(N=58). Oxford Knee Scores (OKS), Euro-quol (EQ-5D) scores, revision rates, and mortality were compared. Results. We found that the octogenarian group achieved considerable improvement at 1 year with a mean OKS of 39.2 (+/−7.193) and EQ-5D score of 0.791(+/−0.241). And this improvement remained significant at 2 years. There was no difference in functional outcome when the 3 groups were compared. Revision rates for the 3 groups from youngest to oldest were, 8.5%, 4.5%, and 6.9% respectively. Odds ratio and survival analysis showed no significant difference between the groups. Conclusion. In conclusion, we found that octogenarians over a 2 year period achieved similar functional outcome as their younger counterparts. Level of Evidence. IV

Background. Tourniquets are routinely used in total knee arthroplasty (TKA) with an estimated use by up to 93% of surgeons. Advantages include the ability to provide a bloodless field of view to facilitate cement application and increase the success of the procedure. Overall reduction in blood loss is another perceived advantage, however recent research has demonstrated no measurable reduction and conversely a substantial increase in complications such as deep vein thrombosis and systemic emboli. Given the significant complications of tourniquet use we aim to identify patients’ views on tourniquets and of emphasis their awareness of the possible risks involved prior to the procedure. Method. A questionnaire-based study was carried out on 35 patients attending an elective orthopaedic centre for TKA surgery. Ethical approval was granted by NRES committee – East of England (REC Ref: 14/EE/1265). Patients were provided with an information sheet detailing the reasons for the tourniquet use and the associated risks and benefits. They were then provided with a questionnaire to ascertain their views and previous understanding of the subject. Simple statistical measures were implemented to analyse the data. Results. Only 32% of patients were aware of the use of tourniquets during the operation. 19% were aware of the benefits prior to reading the information sheet provided with 29% understanding the risks involved prior to their procedure. Finally we found 97% of patients would like more information on the use of tourniquets preoperatively. Conclusion. Tourniquets are widely used in TKA surgery, however, they carry significant risks which are not clearly relayed preoperatively to all patients. Given that 91,000 TKA operations are performed per year we believe it is of paramount importance that all patients are appropriately counselled on the risks and benefits of its use and fully informed consent, including risks of tourniquet use, should be obtained prior to the procedure. Level of Evidence. Level 3

Background. Tourniquets are routinely used in total knee arthroplasty (TKA) with an estimated use by up to 93% of surgeons. Advantages include the ability to provide a bloodless field of view to facilitate cement application and increase the success of the procedure. Overall reduction in blood loss is another perceived advantage, however recent research has demonstrated no measurable reduction and conversely a substantial increase in complications such as deep vein thrombosis and systemic emboli. Given the significant complications of tourniquet use we aim to identify patients' views on tourniquets and of emphasis their awareness of the possible risks involved prior to the procedure. Method. A questionnaire-based study was carried out on 35 patients attending an elective orthopaedic centre for TKA surgery. Ethical approval was granted by NRES committee – East of England (REC Ref: 14/EE/1265). Patients were provided with an information sheet detailing the reasons for the tourniquet use and the associated risks and benefits. They were then provided with a questionnaire to ascertain their views and previous understanding of the subject. Simple statistical measures were implemented to analyse the data. Results. Only 32% of patients were aware of the use of tourniquets during the operation. 19% were aware of the benefits prior to reading the information sheet provided with 29% understanding the risks involved prior to their procedure. Finally we found 97% of patients would like more information on the use of tourniquets preoperatively. Conclusion. Tourniquets are widely used in TKA surgery, however, they carry significant risks which are not clearly relayed preoperatively to all patients. Given that 91,000 TKA operations are performed per year we believe it is of paramount importance that all patients are appropriately counselled on the risks and benefits of its use and fully informed consent, including risks of tourniquet use, should be obtained prior to the procedure. Level of Evidence. Level 3

Background. Despite an ageing population and a rise in the number of joint replacements being performed, the mean age of patients undergoing surgery remains static. One explanation for this is continued concern over the risks of performing surgery on the very elderly. We aim to investigate the outcome of Total Knee Replacement (TKR) in a nonagenarian population. Methods. The Elective Orthopaedic Centre, Epsom has an established patient reported outcome measures (PROMs) programme into which all patients are routinely enrolled. We retrospectively reviewed our data set for a cohort of nonagenarians undergoing primary TKR, between April 2008 and October 2011. Post-operative complications, mortality rates and functional outcomes were compared to those of a time matched 70–79 year old cohort. Only patients with a primary diagnosis of osteoarthritis were included whereas an exclusion criterion consisted of patients undergoing revision surgery, simultaneous bilateral replacements or conversion from a Unicompartmental Knee replacement. Results. We identified 31 nonagenarian patients, with a mean age of 91.0 (90–96) and the control group consisted of 36 patients, with a mean age of 74.5 (70–79). Following a TKR, the nonagenarian cohort achieved a lower mean Oxford Knee Score (OKS) at 1 year (31.7+/−9.5) (p=0.15), but no difference existed by 2 years (p=0.157), and a mean outcome satisfaction of 85.2% (+/− 22.75) at 1 year, which was similar to the younger group. The nonagenarians had a greater risk of requiring a blood transfusion following a TKR (p=0.0373; CI 1.08 to 16.65), and a longer length of stay than their younger counterparts (p=0.001). Mortality rates were higher in the nonagenarian cohort, but these were in keeping with the life expectancy projections identified by the Office for National Statistics. Conclusion. In conclusion, we identified that over a 2 year period, nonagenarians achieved the same functional outcome and satisfaction rates following a TKR as 70–79 year olds. Level of Evidence IV

Last minute cancellations of operations are a major waste of NHS resources. This study identifies the number of late cancellations at our elective orthopaedic centre, the reasons for them, the costs involved, and whether they are avoidable. Last minute cancellations of operations in a 7-month period from January to July 2009 were examined. 172 cases out of 3330 scheduled operations were cancelled at the last minute (5.2%). Significantly more cancellations occurred during the winter months due to seasonal illness. The commonest causes for cancellation in descending order of frequency were patient unfit/unwell (n=76, 44.2%), lack of theatre time (n=32, 18.6%), patient self cancelled/DNA (n=20, 11.6%), staff unavailable or sick (n=9, 5.2%), theatre or equipment problem (n=8, 4.7%), operation no longer required (n=8, 4.7%), administrative error (n=7, 4.1%) or no bed available (n=5, 2.9%). In 7 out of the 172 cancelled cases (4.1%) no cause was identified. 59.7% of the cases were potentially avoidable. 3.2% of Patients seen in the specialist pre-operative anaesthetic clinic (POAC) were cancelled at the last minute for being unfit or unwell, compared to 2.2% seen in the routine nurse led clinic. Last minute cancellations cost the hospital over £700,000 in 7 months

Introduction. Despite an ageing population and a rise in the number of joint replacements being performed, the mean age of patients undergoing surgery remains static. One explanation for this is continued concern over the risks of performing surgery on the very elderly. The Elective Orthopaedic Centre, Epsom has an established patient reported outcome measures (PROMs) programme into which all patients are routinely enrolled. Post-operative complications, Oxford scores and Euro-Quol (EQ5-D) are collected to the second post-operative year. Methods and Results. We retrospectively reviewed our data set for a cohort of nonagenarians undergoing primary total hip replacement (THR) between April 2008 and October 2011. Post-operative complications, mortality rates and functional outcomes were compared to those of a time matched 70–79 year old cohort. Only patients with a primary diagnosis of osteoarthritis were included whereas an exclusion criterion consisted of patients undergoing revision surgery, simultaneous bilateral replacements or conversion from a dynamic hip screw. We identified 38 nonagenarian patients (12 men and 26 women), with a mean age of 92.18 (90–99) and the control group consisted of 55 patients (21 men and 34 women), with a mean age of 74.69 (70–79). We found that nonagenarians requiring a THR presented with lower pre-operative Oxford Hip Score (OHS) (p=0.02) but made a greater improvement in the first post-operative year than the younger cohort (p=0.040). The nonagenarians had a greater risk of requiring a blood transfusion following THR (p= 0.0265; CI 1.11 to 5.75), and also required a longer stay than their younger counterparts (p=0.001). Mortality rates were higher in the nonagenarian cohort, but these were in keeping with the life expectancy projections identified by the Office for National Statistics (ONS). Conclusion. In conclusion, we identified that over a 2 year period, nonagenarians achieved the same functional outcome and satisfaction rates following a THR as 70–79 year olds

Introduction: The aim of this study was to determine the impact of deprivation on access to and outcome from total hip replacement in a district general setting. Methods: A prospective audit was undertaken in an elective orthopaedic centre serving an entire health region. Hip function was collected using the Harris Hip Score (HHS) Patients were followed up for a mean 71 months and the presence of complications noted. Patients were allocated a deprivation category by retrospective application of the Scottish Index of Multiple Deprivation (SIMD) quintiles. Results: A total of 2270 hip replacements were carried out in 2177 patients. There were 93 bilateral simultaneous procedures. The overall incidence of THR was 79.5/100,000 per year. This rate was significantly higher in more deprived areas. 37.4% of THRs occurred in males but there was no significant change with deprivation. Deprivation was not linked with age, length of stay or BMI. There was no association with the prevalence of diabetes, cancer, ischaemic heart disease or hypertension in this group. The incidence of smoking increased with deprivation, with a prevalence of 21.5% in the most deprived group compared to 7.7% in the least (p=0.0001). There was no observed difference in mortality, infection, dislocation, thrombosis or transfusion requirement. Preoperative and postoperative function was significantly different between groups with HHS being lower in the most deprived group compared to the least (p=0.01, p=0.005). There were ‘pockets’ of low and high incidence of THR. These correlate with the age of the population (r=0.69, p< 0.001). Conclusion: We could identify no inequality in access to total hip replacement in our centre and health board region. The incidence of smoking increased with increasing deprivation. Areas with a greater proportion of the population over 60 had an increased incidence of THR. Pre-operative function and outcomes were found to be lower in more deprived groups

Introduction. The need for the stringent surveillance of new devices was recognised by the NICE review of hip replacement surgery in 2000 and led to the Orthopaedic Data Evaluation Panel (ODEP) developing criteria for post-marketing surveillance (PMS) studies. This requirement has been reinforced by the recent recall of ASR devices. Methods. The South West London Elective Orthopaedic Centre's (EOC's) comprehensive outcomes programme has been adapted to manage and coordinate multi-centre, multi-surgeon, PMS studies. The system allows any schedule and combination of patient-reported outcome measures (PROMS), clinical and radiological assessments, and complications to be collected. Typically, PROMS are collected pre-operatively and yearly by post. Baseline clinical assessment is undertaken pre-operatively, with baseline radiological assessments pre- and post-operatively. Subsequent clinical and radiological assessments are usually obtained at the ODEP-mandated time points of 3, 5, 7 and 10 years post-operatively. Patients are telephoned twice yearly to document complications and any impending change of address. Results. EOC co-ordinated studies extend the ODEP criteria to provide high quality evidence on implant survivorship and patient outcome. In one study, over 500 subjects are under review. The operations were undertaken by twelve surgeons, at three centres. At 3 years participant withdrawal is 4%, mortality 4%, loss to follow-up 1% and revisions 0.5%. Average annual return of PROMS is 94%, and the percentage of invited patients returning for a 3 year review is 81%. Discussion. The EOC system provides a cost-effective method for the long-term follow-up of implants through multi-site, multi-surgeon national, and international, PMS studies. Participation by high-volume centres facilitates both rapid recruitment of study participants and the infrastructure required to maintain consistent data quality. The acquired information gives timely information to surgeons, manufacturers and healthcare purchasers. We advocate adoption of the EOC PMS model for all new implants that are introduced to the UK market

Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times for THR can be considerable, and patients often experience significant pain during this time. A pain self-management intervention may provide patients with the skills to enable them to manage their pain and its impact more effectively before surgery. However, studies of arthritis self-management programmes have faced challenges because of low recruitment rates, poor intervention uptake, and high attrition rates. This study aimed to evaluate the feasibility of a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Specific objectives were to assess trial design, ascertain recruitment and retention rates, identify barriers to participation, refine data collection methods, and evaluate uptake and patient satisfaction with the course. Patients listed for THR in an elective orthopaedic centre Bristol, UK were sent a postal invitation about the study. Participants were randomised to attend a pain self-management course plus standard care or standard care only using a computer-generated randomisation system. The pain self-management course was delivered by Arthritis Care and consisted of two half-day group sessions prior to surgery and one full-day group session 2–4 months after surgery. A structured course evaluation questionnaire was completed by participants. Outcomes assessment was by postal questionnaire prior to surgery and 1-month, 3-months and 6-months after surgery. Self-report resource use data were collected using a diary prior to surgery and inclusion of resource use questions in the 3-month and 6-month post-operative questionnaires. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Postal invitations were sent to 385 eligible patients and 88 patients consented to participate (23% recruitment rate). Participants had a mean age of 66 years and 65% were female. Brief interviews with 57 non-participants revealed the most common reasons for non-participation were perceptions about the intervention and difficulties in getting to the hospital for the course. Of the 43 patients randomised to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and patients enjoyed the group format. Retention of participants was acceptable, with 83% completing follow-up. Questionnaire return rates were high (76–93%), with the exception of the pre-operative resource use diary (35%). Completion rates for the resource use questions varied by category and allowed for an economic perspective from the health and social care payer to be taken. Undertaking feasibility work for a RCT is labour-intensive; however this study highlights the importance of conducting such work. Postal recruitment resulted in a low recruitment rate and brief interviews with non-participants provided valuable information on barriers to participation. Embedding collection of resource use data within questionnaires resulted in higher completion rates than using resource use diaries. While patients who attended the course gave positive feedback, attendance was low. Findings from this feasibility study enable us to design successful definitive group-based RCTs in the future

Aims

The aims of this study were to assess mapping models to predict the three-level version of EuroQoL five-dimension utility index (EQ-5D-3L) from the Oxford Knee Score (OKS) and validate these before and after total knee arthroplasty (TKA).