Metal allergy in primary and revision total knee arthroplasty : a scoping review and evidence-based practical approach.

AIMS: Metal allergy in knee arthroplasty patients is a controversial topic. We aimed to conduct a scoping review to clarify the management of metal allergy in primary and revision total knee arthroplasty (TKA). METHODS: Studies were identified by searching electronic databases: Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Embase, from their inception to November 2020, for studies evaluating TKA patients with metal hypersensitivity/allergy. All studies reporting on diagnosing or managing metal hypersensitivity in TKA were included. Data were extracted and summarized based on study design, study population, interventions and outcomes. A practical guide is then formulated based on the available evidence. RESULTS: We included 38 heterogeneous studies (two randomized controlled trials, six comparative studies, 19 case series, and 11 case reports). The evidence indicates that metal hypersensitivity is a rare complication with some histopathological features leading to pain and dissatisfaction with no reliable screening tests preoperatively. Hypoallergenic implants are viable alternatives for patients with self-reported/confirmed metal hypersensitivity if declared preoperatively; however, concerns remain over their long-term outcomes with ceramic implants outperforming titanium nitride-coated implants and informed consent is paramount. For patients presenting with painful TKA, metal hypersensitivity is a diagnosis of exclusion where patch skin testing, lymphocyte transformation test, and synovial biopsies are useful adjuncts before revision surgery is undertaken to hypoallergenic implants with shared decision-making and informed consent. CONCLUSION: Using the limited available evidence in the literature, we provide a practical approach to metal hypersensitivity in TKA patients. Future national/registry-based studies are needed to identify the scale of metal hypersensitivity, agreed diagnostic criteria, and management strategies. Cite this article: Bone Jt Open 2021;2(10):785-795.

Overview of Randomized Controlled Trials in Primary Total Hip Arthroplasty (34,020 Patients): What Have We Learnt?

AIM: To provide an overview of randomized controlled trials (RCTs) in primary total hip arthroplasty summarizing the available high-quality evidence. MATERIALS AND METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA), we searched the Cochrane Central Register of Controlled Trials (2020, Issue 1), Ovid MEDLINE, and Embase. We excluded nonrandomized trials, trials on neck of femur fractures or revision surgery, systematic reviews, and meta-analyses. Trials that met our inclusion criteria were assessed using a binary outcome measure of whether they reported statistically significant findings. These were then classified according to the intervention groups (surgical approach, fixation, and component design use, among others). RESULTS: Three hundred twelve RCTs met the inclusion criteria and were included. The total number of patients in those 312 RCTs was 34,020. Sixty-one RCTs (19.5%) reported significant differences between the intervention and the control groups. The trials were grouped into surgical approach 72, fixation 7, cement 16, femoral stem 46, head sizes 5, cup design 18, polyethylene 25, bearing surfaces 30, metal-on-metal 30, resurfacing 20, navigation 15, robotics 3, surgical technique 12, and closure/drains/postoperative care 13 RCTs. DISCUSSION: The evidence reviewed indicates that for the vast majority of patients, a standard conventional total hip arthroplasty with a surgical approach familiar to the surgeon using standard well-established components and highly cross-linked polyethylene leads to satisfactory clinical outcomes. This evidence also offers arthroplasty surgeons the flexibility to use the standard and cost-effective techniques and achieve comparable outcomes.

Fractured Femoral Stems in Primary and Revision Hip Arthroplasties Revisited: Wrightington Experience.

BACKGROUND: The aim of this study is to present our experience in managing fractured femoral stems over the last 10 years for both primary and revision stems at our tertiary unit focusing on modes of failure and operative techniques. METHODS: This is a retrospective consecutive study of all patients with fractured femoral stems that were operatively managed in our unit between 2008 and 2018. Detailed radiographic evaluation (Paprosky classification) was undertaken and data collected on operative techniques used to extract distal fractured stem fragments. RESULTS: Thirty-five patients (35 hips) were included (25 men/10 women) with average age at time of presentation of 68 years (range, 29-93). Average body mass index was 30 (standard deviation, 3.8; range, 22.5-39). There were variety of stems both contemporary and historical, primary and revision cases (15 hips polished tapered cemented stems, 10 hips composite beam and miscellaneous stems, and 10 revision hip stems). The predominant mechanism of failure was fatigue due to cantilever bending in distally fixed stems. Surgical techniques used to extract distal fragment were drilling technique in 2 hips, cortical window in 13 hips, extended trochanteric osteotomy (ETO) in 5 hips, and proximal extraction in 15 hips. CONCLUSION: When faced with a contemporary fractured stem, drilling techniques into the distal fragment are unlikely to succeed. If a trochanteric osteotomy had been used at time of index surgery, this could be used again to aid proximal extraction with conventional revision instrumentations. The cortical window technique is useful but surgically demanding technique that is most successful in extracting polished tapered fractured stems particularly when an ETO is not planned for femoral reconstruction. Use of trephines can be useful for removal of longer, uncemented stems. Finally, an ETO might be necessary when other techniques have failed.

Early results of a high friction surface coated uncemented socket in revision hip arthroplasty.

BACKGROUND: Revision hip arthroplasty with high friction trabecular metal sockets has resulted in good medium-term results. Many manufacturers have therefore introduced higher friction coatings to their implants to meet a growing demand for similar implants. The Pinnacle Gription was introduced in 2007 as an evolution of the standard Pinnacle socket. This study aimed to assess the early results of this socket in a revision setting. METHODS: Between August 2009 and December 2016, the Gription socket was used in 146 revision hip replacements. The mean age was 63 (19-88) years. Defects were classified as Paprosky Grade 2 in 71(2A [28], 2B [19], 2C [24]) and grade 3 in 20 (3A [18], 3B [2]). Bearing combinations were ceramic-on-ceramic in 23, metal-on-polyethylene in 71, ceramic-on-polyethylene in 52. Screws were used in 112 cases, impaction bone grafting in 34 and metal augments in 1 case. Radiographs were analysed for progressive radiolucent lines and migration. RESULTS: Mean follow-up was 43.5 (range 25-62) months. There were 6 re-revisions (2 for deep infection, 2 for recurrent dislocation and 2 for aseptic loosening). None of the other cases had evidence of socket migration or progressive radiolucent lines. There were no intraoperative or postoperative periprosthetic fractures. The crude survivorship for all-cause failure was 95.8% and the survivorship for aseptic loosening was 98.6%. at 43.5 months follow-up. CONCLUSIONS: This is the largest reported series of Gription socket use in revision arthroplasty and demonstrates encouraging early results. We therefore advocate the continued cautious use of this implant.

Is patient satisfaction related to patient reported sounds from ceramic on ceramic total hip arthroplasty? A study of 265 hips.

INTRODUCTION: The ideal method and implant to perform total hip arthroplasty (THA) is still a debated topic. Ceramic on ceramic (CoC) bearings have favourable wear properties, but squeaking has been reported as an unwanted side effect. We aimed to determine the rate of noise generation from CoC hips and investigate whether there is a relationship with patient satisfaction. METHODS: A total of 246 consecutive CoC bearing uncemented THA were retrospectively identified in a single institution. Post-operatively patients were sent a postal questionnaire to evaluate their reported sounds and satisfaction with their THA. Uni- and multi-variate analyses were performed to identify potential predictor variables for reported post-operative sounds. RESULTS: Questionnaires were returned by 172 patients (70% return rate). 24% reported sounds from their hips with 11% reporting a squeak. Median satisfaction levels were minimally, but significantly less for "noisy" (9/10) than "quiet" hips (10/10) (median difference = - 1, 95% CI - 2 to 0, p < 0.001). Compared to those with "noisy" hips, patients with "quiet" hips were 1.7 times (95% CI 1.3-2.5, p = 0.0002) more likely to report a "forgotten" hip. Younger age (p < 0.043) and increased anteversion (p < 0.021) were predictors for reported sounds. CONCLUSION: We have identified a high rate of "noisy" hips in this series of CoC THA with a significant inverse relationship between "noisy" hips and patient satisfaction levels. In our unit, we are moving towards the use of ceramic on cross-linked polyethylene bearings as a result of these findings and the excellent survivorship of this bearing combination.

Does oversizing an uncemented cup increase post-operative pain in primary total hip arthroplasty?

INTRODUCTION: It has been suggested that one of the factors related to persistent post-operative pain following total hip arthroplasty (THA) is to over sizing of the acetabular component. In order to investigate this potential issue, we retrospectively analysed a series of consecutive uncemented THA. We assessed the incidence of persistent post-operative pain and the size difference between the implanted acetabular component and the native femoral head. METHODS: A total of 265 consecutive THAs were retrospectively identified. Standardised pre-operative radiographs were analysed using validated techniques to determine the native femoral head diameter. Post-operative standardised radiographs were reviewed and the acetabular orientation determined. Patients were sent postal questionnaires regarding their outcome and level of pain. RESULTS: Questionnaires were returned by 169 patients (189 hips, 71% response rate). A total of 17 were excluded due to inadequate radiographs., leaving 172 THA in the study group. The mean native femoral head (NFH) size was 47 mm. The most common implanted acetabular component size was 52 mm. The mean difference in cup to NFH diameter (delta) was 5.7 mm (range - 6.1 to 15.4 mm; 95% CI 5.3-6.2 mm). A delta of > 6 mm was found to be significant for predicting persistent post-operative pain (RR = 1.81; 95% CI 1.1-3.1; P = 0.027). CONCLUSION: Our study confirms that a delta of > 6 mm is associated with an increased risk of persistent post-operative pain following THA. We recommend pre-operative templating in all uncemented THA to ensure the planned acetabular component is no more than 6 mm larger than the NFH diameter.

Hip replacement.

Total hip replacement is a frequently done and highly successful surgical intervention. The procedure is undertaken to relieve pain and improve function in individuals with advanced arthritis of the hip joint. Symptomatic osteoarthritis is the most common indication for surgery. In paper 1 of this Series, we focus on how patient factors should inform the surgical decision-making process. Substantial demands are placed upon modern implants, because patients expect to remain active for longer. We discuss the advances made in implant performance and the developments in perioperative practice that have reduced complications. Assessment of surgery outcomes should include patient-reported outcome measures and implant survival rates that are based on data from joint replacement registries. The high-profile failure of some widely used metal-on-metal prostheses has shown the shortcomings of the existing regulatory framework. We consider how proposed changes to the regulatory framework could influence safety.

The risk of developing cancer following metal-on-metal hip replacement compared with non metal-on-metal hip bearings: Findings from a prospective national registry "The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man".

BACKGROUND AND PURPOSE: Over 1 million metal-on-metal hip replacements were implanted. Even well-functioning implants produce wear debris that can cause tissue damage, disseminate and cause DNA damage. We aimed to establish if there was an association between metal-on-metal hip replacement and the risk of subsequently developing cancer compared with alternative hip replacements. METHODS: We performed a population based prospective longitudinal cohort study using data from the National Joint Registry linked to Hospital Episode Statistics (n = 403,881 patients). We examined the incidence of a new diagnosis of cancer in patients who received a metal-on-metal bearing in comparison with those who received a non metal-on-metal bearing. Kaplan-Meier estimates of time to first cancer diagnosis were used with Cox proportional hazards regression models to assess the effect on the time to cancer diagnosis for all cancer types, haematological, malignant melanoma, urinary tract cancers or prostate cancer in men. RESULTS: The maximum follow up available was 11.8 years with 25% of patients followed up for more than 6.8 years (mean follow up 4.6 years; median 4.3; IQR 2.1-6.8; range 0.01-11.8). Analyses by gender that adjusted for age at primary and presence or absence of linked Welsh (PEDW) records showed no increase in the risk of developing cancer according to the bearing surface implanted for all cancers, haematological cancers, malignant melanoma, urinary tract cancers or prostate cancer in men. For patients receiving a second hip replacement, there was also no difference. CONCLUSION: We have demonstrated that there is currently no evidence of an increase in the risk of cancer following primary hip replacement according to the type of bearing material used. Although the risk of revision in metal-on-metal bearing hip replacements is higher, it is reassuring that the risk of a new diagnosis of cancer is not currently increased. Despite the long term follow up available in this study, the latency period for some cancers is very long and therefore continued monitoring is required to ensure no new patterns emerge that may indicate need for universal screening.

Implications of Introducing New Technology: Comparative Survivorship Modeling of Metal-on-Metal Hip Replacements and Contemporary Alternatives in the National Joint Registry.

BACKGROUND: New medical technologies are often used widely without adequate supporting data, a practice that can lead to widespread catastrophic failure such as occurred with metal-on-metal (MoM) hip replacements. We determined both how revision rates would have differed if, instead of receiving MoM hip replacements, patients had received existing alternatives and the subsequent cumulative re-revision rates of the patients who did receive MoM hip replacements compared with alternatives. METHODS: This study is a population-based longitudinal cohort study of patient data recorded in the National Joint Registry (NJR) for England, Wales and Northern Ireland between April 2003 and December 2014. We ascertained implant failure rates separately among stemmed MoM total hip replacement (THR) and hip-resurfacing procedures and, using flexible parametric survival modeling, compared them with the failure rates that would have been expected had existing alternatives been used. We used Kaplan-Meier survivorship analysis to compare cumulative re-revision of patients who received stemmed MoM primary replacements that failed and of those who underwent hip resurfacing that failed with those whose non-MoM THRs had failed. RESULTS: In all, 37,555 patients underwent MoM hip resurfacing, with a 10-year revision rate of 12.6% (95% confidence interval [CI]: 12.2% to 13.1%) compared with a predicted revision rate of 4.8% if alternative implants had been used. The 32,024 stemmed MoM THRs had a 19.8% (95% CI: 18.9% to 20.8%) 10-year failure rate compared with an expected rate of 3.9% if alternatives had been used. For every 100 MoM hip-resurfacing procedures, there were 7.8 excess revisions by 10 years, and for every 100 stemmed MoM THR procedures, there were 15.9, which equates to 8,021 excess first revisions. Seven-year re-revision rates were 14.9% (95% CI: 13.8% to 16.2%) for stemmed non-MoM THRs, 18.0% (95% CI: 15.7% to 20.7%) for MoM hip resurfacing, and 19.8% (95% CI: 17.0% to 23.0%) for stemmed MoM THRs. CONCLUSIONS: This study highlights the consequences of widespread and poorly monitored adoption of a medical technology. Over 1 million MoM hip prostheses were implanted worldwide. The excess failure on a global scale will be enormous. This practice of adopting new technologies without adequate supporting data must not be repeated. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Description of the rates, trends and surgical burden associated with revision for prosthetic joint infection following primary and revision knee replacements in England and Wales: an analysis of the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

OBJECTIVES: To describe the prevalence rates of revision surgery for the treatment of prosthetic joint infection (PJI) for patients undergoing knee replacement, their time trends, the cumulative incidence function of revision for PJI and estimate the burden of PJI at health service level. DESIGN: We analysed revision knee replacements performed due to a diagnosis of PJI and the linked index procedures recorded in the National Joint Registry from 2003 to 2014 for England and Wales. The cohort analysed consisted of 679 010 index primary knee replacements, 33 920 index revision knee replacements and 8247 revision total knee replacements performed due to a diagnosis of PJI. The prevalence rates, their time trends investigated by time from index surgery to revision for PJI, cumulative incidence functions and the burden of PJI (total procedures) were calculated. Overall linear trends were investigated with log-linear regression. RESULTS: The incidence of revision total knee replacement due to PJI at 2 years was 3.2/1000 following primary and 14.4/1000 following revision knee replacement, respectively. The prevalence of revision due to PJI in the 3 months following primary knee replacement has risen by 2.5-fold (95% CI 1.2 to 5.3) from 2005 to 2013 and 7.5-fold (95% CI 1.0 to 56.1) following revision knee replacement. Over 1000 procedures per year are performed as a consequence of knee PJI, an increase of 2.8 from 2005 to 2013. Overall, 75% of revisions were two-stage with an increase in use of single-stage from 7.9% in 2005 to 18.8% in 2014. CONCLUSIONS: Although the risk of revision due to PJI following knee replacement is low, it is rising, and coupled with the established and further predicted increased incidence of both primary and revision knee replacements, this represents an increasing and substantial treatment burden for orthopaedic service delivery in England and Wales. This has implications for future service design and the funding of individual and specialist centres.

The Main Cause of Death Following Primary Total Hip and Knee Replacement for Osteoarthritis: A Cohort Study of 26,766 Deaths Following 332,734 Hip Replacements and 29,802 Deaths Following 384,291 Knee Replacements.

BACKGROUND: Patients undergoing primary total joint replacement are selected for surgery and thus (other than having a transiently increased mortality rate postoperatively) have a lower mortality rate than age and sex-matched individuals do. Understanding the causes of death following joint replacement would allow targeted strategies to reduce the risk of death and optimize outcome. We aimed to determine the rates and causes of mortality for patients undergoing primary total hip or knee replacement compared with individuals in the general population who were matched for age and sex. METHODS: We compared causes and rates of mortality between age and sex-matched individuals in the general population (National Joint Registry for England, Wales and Northern Ireland; Hospital Episode Statistics; and Office for National Statistics) and a linked cohort of 332,734 patients managed with total hip replacement (26,766 of whom died before the censoring date) and 384,291 patients managed with primary total knee replacement (29,802 of whom died before the censoring date) from 2003 through 2012. RESULTS: The main causes of death were malignant neoplasms (33.8% [9,037] of 26,766 deaths in patients with total hip replacement and 33.3% [9,917] of 29,802 deaths in patients with total knee replacement), circulatory system disorders (32.8% [8,784] of the deaths in patients with total hip replacement and 33.3% [9,932] of the deaths in patients with total knee replacement), respiratory system disorders (10.9% [2,928] of the deaths in patients with total hip replacement and 9.8% [2,932] of the deaths in patients with total knee replacement), and digestive system diseases (5.5% [1,465] of the deaths in patients with total hip replacement and 5.3% [1,572] of the deaths in patients with total knee replacement). There was a relative reduction in mortality (39%) compared with the individuals in the general population that equalized to the rate in the general population by 7 years for hips (overall standardized mortality ratio [SMR], 0.61; 95% confidence interval [CI], 0.60 to 0.62); for knees, the relative reduction (43%) partially attenuated by 7 years but still had not equalized to the rate in the general population (overall SMR, 0.57; 95% CI, 0.56 to 0.57). Ischemic heart disease was the most common cause of death within 90 days (29% [431] of the deaths in patients with primary hip replacement and 31% [436] of the deaths in patients with primary knee replacement). There was an elevated risk of death from circulatory, respiratory, and (most markedly) digestive system-related causes within 90 days postoperatively compared with 91 days to 1 year postoperatively. CONCLUSIONS: Ischemic heart disease is the leading cause of death in the 90 days following total joint replacement, and there is an increase in postoperative deaths associated with digestive system-related disease following joint replacement. Interventions targeted at reducing these diseases may have the largest effect on mortality in total joint replacement patients. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Osteochondral lesion of the hip treated with partial femoral head resurfacing. Case report and six-year follow-up.

INTRODUCTION: This case describes a case of an osteochondral lesion in the femoral head and its treatment by partial resurfacing of the femoral head using the HemiCAP (Contoured Articular Prosthetic) hip resurfacing system. CASE HISTORY: A 19-year-old patient who complained of 15 months of worsening left hip pain. X-rays and MR scan revealed a large osteochondral lesion. SURGERY: A Ganz approach to the hip in the lateral position was used. The osteochondral lesion was identified, lying superiorly and centrally on the head, in the weight bearing zone. The osteochondral fragment was removed and HemiCAP prosthesis applied. OUTCOME: At six-year follow-up the patient remains pain free clinically. And radiographic follow-up shows no evidence of loosening. CONCLUSION: There are multiple methods of treatment described in the literature for osteochondral lesions; but treatments for defects of the femoral head are few. We conclude that partial hip resurfacing using the HemiCAP prosthesis is an effective treatment for osteochondral defects of the femoral head.

Clinical experience of revision of metal on metal hip arthroplasty for aseptic lymphocyte dominated vasculitis associated lesions (ALVAL).

There has been growing concern regarding the systemic and local effects of metal ions released from metal-on-metal hip resurfacings and total hip replacements, including the development of aseptic lymphocyte dominated vasculitis associated lesions (ALVAL). We describe our experience of treating 13 patients with failed metal on metal bearing hip prostheses secondary to this condition. Hip revision occurred at mean of 45 months following primary surgery. Groin pain was present in all patients. Other common features included large bursal swelling and mechanical symptoms. 3 patients developed their symptoms immediately postoperatively. The mean time to presentation was 21 months. Radiographic abnormalities noted included 3 patients with cup loosening and 2 patients with neck thinning. The mean cup inclination was 52 degrees. Surgical findings included bursal swellings and creamy brown fluid. Osteolysis was rarely seen. 12 revisions were achieved with primary implants and all patients had immediate symptomatic improvement. One patient was left with a pseudoarthrosis due to extensive soft tissue destruction. Diagnosis of ALVAL was confirmed histologically. The diagnosis of ALVAL should be considered in patients with unexplained pain from a metal on metal bearing hip arthroplasty. Surgical findings are typical and symptoms tend to resolve reliably following conversion to an alternative bearing surface.

Notes on the use and interpretation of radiostereometric analysis.

With increasing numbers of research groups carrying out radiostereometric analysis (RSA), it is important to reach a consensus on how the main aspects of the technique should be carried out and how the results should be presented in an appropriate and consistent way. In this collection of guidelines, we identify a number of methodological and reporting issues including: measurement error and precision, migration and migration direction data, and the use of RSA as a screening technique. Alternatives are proposed, and a statistical analysis is presented, from which a sample size of 50 is recommended for screening of newly introduced prostheses.

Medium-term results with the Press Fit Condylar (PFC) Sigma knee prosthesis the Wrightington experience.

The PFC Sigma total knee was introduced in 1997, incorporating a number of design changes. We report the mid-term results of a consecutive series of PFC Sigma knee arthroplasties performed between November 1997 and December 1998. Out of a total of 156 patients (166 knees), 5 patients (5 knees) were lost to follow-up and 6 patients (6 knees) died of unrelated causes. This left 145 patients (155 knees), 90 female and 55 male, with a mean age of 70 years (range, 53-88) and an average follow-up of 90 months (range, 84-96). Posterior cruciate retaining components were used in 136 knees (88%) and posterior-stabilized in 19 (12%). The patella was resurfaced in 74 (48%) knees. Follow-up was at 3, 6 and 12 months, then yearly. Preoperative American Knee Society and Oxford scores were compared with follow-up scores. The Knee Society radiological score was used for radiographic assessment. One knee (0.6%) was revised due to aseptic loosening. One knee (0.6%) had superficial wound infection, which settled with oral antibiotics. Two knees became deeply infected. Of these, one resolved following early debridement, the other developed chronic infection. Using revision for any reason as the end-point our cumulative success rate was 99.4%. The mean preoperative Knee score improved from 45 (30-65) to 84 (45-92), Functional score from 38 (25-55) to 73 (50-95) and Oxford score from 43 (33-52) to 17 (14-29). Radiographic review showed radiolucent lines in 54 (35%) tibial and 17 (11%) femoral components. The Radiological Knee Society score was less than 4 in all except one tibia where the score was 7. Our study shows excellent clinical results with the PFC Sigma total knee replacement after almost eight years follow-up.

A study of the effect of tibial tray rotation on a specific mobile bearing total knee arthroplasty.

We presumed that a particular mobile-bearing knee prosthesis would cope with tibial tray rotation about its longitudinal axis. We studied the tibiofemoral and patellofemoral joints to assess this. The prosthesis was mounted on a specially designed jig. The tray was externally rotated in 5 degrees increments and put through a range of flexion. We found that increasing tibial tray rotation caused excessive polyethylene loading and, eventually, medial femoral component liftoff. The patellofemoral joint showed increasing lateral patella facet contact. Surprisingly, this mobile-bearing prosthesis could not cope with tibial tray rotation. It required the tibial tray to be neutrally aligned to the femoral component to avoid excessive polyethylene loading.