Hip resurfacing arthroplasty in young patients: international high-volume centres' report on the outcome of 11,382 metal-on-metal hip resurfacing arthroplasties in patients ⩽50 years at surgery.

BACKGROUND: Total hip arthroplasty (THA) in patients younger than 50 years poses significant challenges including postoperative limitations of activity and higher failure rates. Sub-par outcomes of hip resurfacing arthroplasty (HRA) in registries remain controversial due to multiple confounders. Favourable HRA results in some studies are often regarded as irreproducible. The aim of this study is to analyse HRA outcomes in a large international cohort. PATIENTS AND METHODS: We compiled a database of 11,382 HRA patients ⩽50 years from an international group of 27 experienced HRA centres from 13 countries. 18 different metal-on-metal (MoM) HRA designs were included with a mean follow-up of 7.6 years. Outcomes were implant survivorship, revision rates, causes for revision, clinical scores and metal ion levels. Outcomes were compared between genders, sizes, implant types and pre-operative diagnoses. RESULTS: Overall cumulative Kaplan-Meier survivorship was 88.9% at 22 years (95% CI: 88.3-89.5%). 2 HRA designs (DePuy Articular Surface Replacement (ASR), and Corin Cormet Hip Resurfacing System (CORMET)) led to inferior results while all others yielded similar survivorships. Excluding ASR and CORMET, implant survivorship in 11,063 cases was 95% at 10 years and 90% at 22 years. In men, implant survivorship was excellent: 99% at 10 years and 92.5% at 21 years. In females, implant survivorship was 90% at 10 years and 81.3% at 22 years. The overall revision rate was 3.6% with most common reasons for revision being implant loosening and adverse local tissue reactions. The best survivorship was found in patients with osteoarthritis (95% CI, 92.1-93.3% at 22 years), the poorest was among dysplastic hips (78.3%; 95% CI, 76.5-80.1% at 20 years, p < 0.001). CONCLUSIONS: Comparable revision rates demonstrated here may mitigate some concerns for safety and longevity of MoM HRA implants. Higher demands for activity and functionality in younger patients make HRA a potential alternative to THA.

Effect of anti-interleukin drugs in patients with COVID-19 and signs of cytokine release syndrome (COV-AID): a factorial, randomised, controlled trial.

BACKGROUND: Infections with SARS-CoV-2 continue to cause significant morbidity and mortality. Interleukin (IL)-1 and IL-6 blockade have been proposed as therapeutic strategies in COVID-19, but study outcomes have been conflicting. We sought to study whether blockade of the IL-6 or IL-1 pathway shortened the time to clinical improvement in patients with COVID-19, hypoxic respiratory failure, and signs of systemic cytokine release syndrome. METHODS: We did a prospective, multicentre, open-label, randomised, controlled trial, in hospitalised patients with COVID-19, hypoxia, and signs of a cytokine release syndrome across 16 hospitals in Belgium. Eligible patients had a proven diagnosis of COVID-19 with symptoms between 6 and 16 days, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO2:FiO2) of less than 350 mm Hg on room air or less than 280 mm Hg on supplemental oxygen, and signs of a cytokine release syndrome in their serum (either a single ferritin measurement of more than 2000 µg/L and immediately requiring high flow oxygen or mechanical ventilation, or a ferritin concentration of more than 1000 µg/L, which had been increasing over the previous 24 h, or lymphopenia below 800/mL with two of the following criteria: an increasing ferritin concentration of more than 700 µg/L, an increasing lactate dehydrogenase concentration of more than 300 international units per L, an increasing C-reactive protein concentration of more than 70 mg/L, or an increasing D-dimers concentration of more than 1000 ng/mL). The COV-AID trial has a 2 × 2 factorial design to evaluate IL-1 blockade versus no IL-1 blockade and IL-6 blockade versus no IL-6 blockade. Patients were randomly assigned by means of permuted block randomisation with varying block size and stratification by centre. In a first randomisation, patients were assigned to receive subcutaneous anakinra once daily (100 mg) for 28 days or until discharge, or to receive no IL-1 blockade (1:2). In a second randomisation step, patients were allocated to receive a single dose of siltuximab (11 mg/kg) intravenously, or a single dose of tocilizumab (8 mg/kg) intravenously, or to receive no IL-6 blockade (1:1:1). The primary outcome was the time to clinical improvement, defined as time from randomisation to an increase of at least two points on a 6-category ordinal scale or to discharge from hospital alive. The primary and supportive efficacy endpoints were assessed in the intention-to-treat population. Safety was assessed in the safety population. This study is registered online with ClinicalTrials.gov (NCT04330638) and EudraCT (2020-001500-41) and is complete. FINDINGS: Between April 4, and Dec 6, 2020, 342 patients were randomly assigned to IL-1 blockade (n=112) or no IL-1 blockade (n=230) and simultaneously randomly assigned to IL-6 blockade (n=227; 114 for tocilizumab and 113 for siltuximab) or no IL-6 blockade (n=115). Most patients were male (265 [77%] of 342), median age was 65 years (IQR 54-73), and median Systematic Organ Failure Assessment (SOFA) score at randomisation was 3 (2-4). All 342 patients were included in the primary intention-to-treat analysis. The estimated median time to clinical improvement was 12 days (95% CI 10-16) in the IL-1 blockade group versus 12 days (10-15) in the no IL-1 blockade group (hazard ratio [HR] 0·94 [95% CI 0·73-1·21]). For the IL-6 blockade group, the estimated median time to clinical improvement was 11 days (95% CI 10-16) versus 12 days (11-16) in the no IL-6 blockade group (HR 1·00 [0·78-1·29]). 55 patients died during the study, but no evidence for differences in mortality between treatment groups was found. The incidence of serious adverse events and serious infections was similar across study groups. INTERPRETATION: Drugs targeting IL-1 or IL-6 did not shorten the time to clinical improvement in this sample of patients with COVID-19, hypoxic respiratory failure, low SOFA score, and low baseline mortality risk. FUNDING: Belgian Health Care Knowledge Center and VIB Grand Challenges program.

An evaluation of the influence of force- and weight bearing (a)symmetry on patient reported outcomes after total knee arthroplasty.

It has been reported that balance impairments and asymmetrical movement patterns occur in patients after total kne arthroplasty (TKA). The purpose of this study was to evaluate if force- and weight-bearing asymmetry correlate with patient-reported outcomes (PROMs). Twenty patients were prospectively analysed up to 6 months after TKA. Quadriceps- and hamstring force were measured using a hand-held dynamometer. Vertical ground reaction forces during sit-to-stand, stair descending and squatting were assessed by force plates. Patients were asked to complete the KOOS, OKS and 2011 KSS. The symmetry-ratios during sit-to-stand, squat and stair-descent improved significantly. Preopera-tive quadriceps-force was positively correlated with KOOS-Symptoms (r=0.583, p=0.037). The pre-operative load-symmetry ratio during STS was negatively correlated with improvement in KOOS Pain (r=-0.675, p=0.011) and Symptoms (r=-0.674, p=0.008). In deep flexion, preoperative bodyweight ratio was positively correlated with postoperative OKS (r=0.601, p=0.039), KSS-Satisfaction (r=0.675, p=0.011) and improvement in KSS-Satisfaction (r=0.684, p=0.029). Weight bearing and force asymmetry do exist before TKA and take up to at least 6-months to fully recover. The more symmetry in muscle-force and weight-bearing is found preoperatively, the better the PROMs will be at 6 months after surgery.

The Ototoxic Potential of Cobalt From Metal-on-Metal Hip Implants: Objective Auditory and Vestibular Outcome.

OBJECTIVES: During the past decade, the initial popularity of metal-on-metal (MoM) hip implants has shown a progressive decline due to increasingly reported implant failure and revision surgeries. Local as well as systemic toxic side effects have been associated with excessive metal ion release from implants, in which cobalt (Co) plays an important role. The rare condition of systemic cobaltism seems to manifest as a clinical syndrome with cardiac, endocrine, and neurological symptoms, including hearing loss, tinnitus, and imbalance. In most cases described in the literature, revision surgery and the subsequent drop in blood Co level led to (partial) alleviation of the symptoms, suggesting a causal relationship with Co exposure. Moreover, the ototoxic potential of Co has recently been demonstrated in animal experiments. Since its ototoxic potential in humans is merely based on anecdotal case reports, the current study aimed to prospectively and objectively examine the auditory and vestibular function in patients implanted with a MoM hip prosthesis. DESIGN: Twenty patients (15 males and 5 females, aged between 33 and 65 years) implanted with a primary MoM hip prosthesis were matched for age, gender, and noise exposure to 20 non-implanted control subjects. Each participant was subjected to an extensive auditory (conventional and high-frequency pure tone audiometry, transient evoked and distortion product otoacoustic emissions [TEOAEs and DPOAEs], auditory brainstem responses [ABR]) and vestibular test battery (cervical and ocular vestibular evoked myogenic potentials [cVEMPs and oVEMPs], rotatory test, caloric test, video head impulse test [vHIT]), supplemented with a blood sample collection to determine the plasma Co concentration. RESULTS: The median [interquartile range] plasma Co concentration was 1.40 [0.70, 6.30] µg/L in the MoM patient group and 0.19 [0.09, 0.34] µg/L in the control group. Within the auditory test battery, a clear trend was observed toward higher audiometric thresholds (11.2 to 16 kHz), lower DPOAE (between 4 and 8 kHz), and total TEOAE (1 to 4 kHz) amplitudes, and a higher interaural latency difference for wave V of the ABR in the patient versus control group (0.01 ≤ p < 0.05). Within the vestibular test battery, considerably longer cVEMP P1 latencies, higher oVEMP amplitudes (0.01 ≤ p < 0.05), and lower asymmetry ratio of the vHIT gain (p < 0.01) were found in the MoM patients. In the patient group, no suggestive association was observed between the plasma Co level and the auditory or vestibular outcome parameters. CONCLUSIONS: The auditory results seem to reflect signs of Co-induced damage to the hearing function in the high frequencies. This corresponds to previous findings on drug-induced ototoxicity and the recent animal experiments with Co, which identified the basal cochlear outer hair cells as primary targets and indicated that the cellular mechanisms underlying the toxicity might be similar. The vestibular outcomes of the current study are inconclusive and require further elaboration, especially with respect to animal studies. The lack of a clear dose-response relationship may question the clinical relevance of our results, but recent findings in MoM hip implant patients have confirmed that this relationship can be complicated by many patient-specific factors.

Economic Evaluation of Antibacterial Coatings on Healthcare Costs in First Year Following Total Joint Arthroplasty.

BACKGROUND: Antibacterial coatings (ABCs) of implants have proven safe and effective to reduce postsurgical infection, but little is known about their possible economic impact on large-scale use. This study evaluated the point of economic balance, during the first year after surgery, and the potential overall annual healthcare cost savings of 3 different antibacterial technologies applied to joint arthroplasty: a dual-antibiotic-loaded bone cement (COPAL G + C), an antibacterial hydrogel coating (DAC), and a silver coating (Agluna). METHODS: The variables included in the algorithm were average cost and number of primary joint arthroplasties; average cost per patient of the ABC; incidence of periprosthetic joint infections and expected reduction using the ABCs; average cost of infection treatment and expected number of cases. RESULTS: The point of economic balance for COPAL G + C, DAC, and Agluna in the first year after surgery was reached in patient populations with an expected postsurgical infection rate of 1.5%, 2.6%, and 19.2%, respectively. If applied on a national scale, in a moderately high-risk population of patients with a 5% expected postsurgical infection rate, COPAL G + C and DAC hydrogel would provide annual direct cost savings of approximately €48,800,000 and €43,200,000 (€1220 and €1080 per patient), respectively, while the silver coating would be associated with an economic loss of approximately €136,000,000. CONCLUSION: This economic evaluation shows that ABC technologies have the potential to decrease healthcare costs primarily by decreasing the incidence of surgical site infections, provided that the technology is used in the appropriate risk class of patients.

Improved walking distance and range of motion predict patient satisfaction after TKA.

PURPOSES: The focus in the evaluation of total knee arthroplasty has shifted from objective measures of implant position and knee function, to patient-reported outcome measures (PROMs). The relation between these two measures was investigated and the possibility of prediction of the patient satisfaction level was evaluated by defining thresholds for improvement of (1) range of motion (ROM), (2) 6-min walk test (6MWT), (3) sit-to-stand test (STS) and (4) quadriceps force after TKA? METHODS: Fifty-seven patients were prospectively tested at preoperative and 6 months postoperative intervals. The ROM, 6MWT, STS-test and quadriceps force were evaluated. Two clusters were created based on the postoperative KOOS, OKS and the satisfaction subscore of the new KSS, cluster 1 consisted of patients with good to excellent PROMs, cluster 2 of patients with poorer PROMs. Patients in each cluster were more similar to each other than to those in the other cluster. Receiver operating characteristic (ROC)-curve analysis was used to identify thresholds for the functional outcomes that established cluster allocation. Multiple logistic regression was used to define a model to predict cluster allocation. RESULTS: Patients with high postoperative PROMs (cluster 1 allocation) showed higher postoperative functional outcomes (p < 0.05). Thresholds for the improvement of ROM (≥ 5°, OR 6.3, 95% CI 1.23-31.84), 6MWT (≥ 50 m, OR 8.2, 95% CI 1.61-42.18) STS (≥ 1.05 s, OR 3, 95% CI 0.56-16.07) and normalized Q4 force (≥ 1.5 N/BMI, OR 2.5, 95% CI 0.49-12.89) were found to be predictors of cluster allocation. A model to predict the cluster allocation contained gender, ROM improvement and 6MWT improvement (sensitivity 91.1%, specificity 75%). CONCLUSIONS: Thresholds for improvement of functional parameters can predict the patient satisfaction cluster. Patients, who are male, improve on the 6-min walk test with 50 m or more and have an increased range of motion of 5° or more, compared to the preoperative situation, are 6-8 times more likely of being satisfied after TKA. These tests are easy to use in clinical practice and can predict the level of patient satisfaction after TKA. LEVEL OF EVIDENCE: Level II, prognostic study.

High serum ion levels in Conserve Plus big femoral head cemented total hip arthroplasty.

AIM: We report the short-term clinical, radiographic and ion level data of the Conserve Plus metal-on-metal (MoM) big femoral head (BFH) total hip arthroplasty (THA), used with a cemented cobalt-chrome (Co-Cr) Profemur Xm stem and a titanium (Ti) modular neck. RESULTS: In a consecutive series of 40 hips, survivorship at 3 years was 92.5% with revision for any reason. Average Harris Hip Score was 91.3. There were no implant loosenings. No osteolysis was observed. 5 patients had signs of adverse local tissue reaction (ALTR); their clinical scores were not different from the whole cohort. All but 1 patient had their Co serum ion levels measured. The average Co level was 14,1 µg/l (range 0.9-29.0; median 13.0 µg/l). Clinical scores did not correlate with ion level data. A comparative group of 42 hip resurfacing arthroplasties from the same manufacturer had significantly lower serum Co levels: 1.51 µg/l (range 0.9-4.0; median 0.9 µg/l). CONCLUSIONS: All patients with the MoM BFH THA design should be followed regularly and should have ion level testing.

A New Prediction Model for Patient Satisfaction After Total Knee Arthroplasty.

BACKGROUND: Total knee arthroplasty (TKA) is a proven and cost-effective treatment for osteoarthritis. Despite the good to excellent long-term results, some patients remain dissatisfied. Our study aimed at establishing a predictive model to aid patient selection and decision-making in TKA. METHODS: Using data from our prospective arthroplasty outcome database, 113 patients were included. Preoperatively and postoperatively, the patients completed 107 questions in 5 questionnaires: Knee Injury and Osteoarthritis Outcome Score, Oxford Knee Score, Pain Catastrophizing Scale, Euroqol questionnaire, and Knee Scoring System. First, outcome parameters were compared between the satisfied and dissatisfied group. Second, we developed a new prediction tool using regression analysis. Each outcome score was analyzed with simple regression. Subsequently, the predictive weight of individual questions was evaluated applying multiple linear regression. Finally, 10 questions were retained to construct a new prediction tool. RESULTS: Overall satisfaction rate in this study was found to be 88%. We identified a significant difference between the satisfied and dissatisfied group when looking at the preoperative questionnaires. Dissatisfied patients had more preoperative symptoms (such as stiffness), less pain, and a lower quality of life. They were more likely to ruminate and had a lower preoperative Knee Scoring System satisfaction score. The developed prediction tool consists of 10 simple but robust questions. Sensitivity was 97% with a positive-predictive value of 93%. CONCLUSIONS: Based upon preoperative parameters, we were able to partially predict satisfaction and dissatisfaction after TKA. After further validation, this new prediction tool for patient satisfaction following TKA may allow surgeons and patients to evaluate the risks and benefits of surgery on an individual basis and help in patient selection.

Meniscal Allograft Transplantation Does Not Prevent or Delay Progression of Knee Osteoarthritis.

BACKGROUND: Meniscal tears are common knee injuries. Meniscal allograft transplantation (MAT) has been advocated to alleviate symptoms and delay osteoarthritis (OA) after meniscectomy. We investigated (1) the long-term outcome of MAT as a treatment of symptomatic meniscectomy, (2) most important factors affecting survivorship and (3) OA progression. METHODS: From 1989 till 2013, 329 MAT were performed in 313 patients. Clinical and radiographic results and MAT survival were evaluated retrospectively. Failure was defined as conversion to knee arthroplasty (KA) or total removal of the MAT. RESULTS: Mean age at surgery was 33 years (15-57); 60% were males. No-to-mild cartilage damage was found in 156 cases, moderate-to-severe damage in 130. Simultaneous procedures in 118 patients included cartilage procedures, osteotomy or ACL-reconstruction. At a mean follow-up of 6.8 years (0.2-24.3years), 5 patients were deceased and 48 lost (14.6%), 186 MAT were in situ (56.5%) whilst 90 (27.4%) had been removed, including 63 converted to a KA (19.2%). Cumulative allograft survivorship was 15.1% (95% CI:13.9-16.3) at 24.0 years. In patients <35 years at surgery, survival was significantly better (24.1%) compared to ≥35 years (8.0%) (p = 0.017). In knees with no-to-mild cartilage damage more allografts survived (43.0%) compared to moderate-to-severe damage (6.6%) (p = 0.003). Simultaneous osteotomy significantly deteriorated survival (0% at 24.0 years) (p = 0.010). 61% of patients underwent at least one additional surgery (1-11) for clinical symptoms after MAT. Consecutive radiographs showed significant OA progression at a mean of 3.8 years (p<0.0001). Incremental Kellgren-Lawrence grade was +1,1 grade per 1000 days (2,7yrs). CONCLUSIONS: MAT did not delay or prevent tibiofemoral OA progression. 19.2% were converted to a knee prosthesis at a mean of 10.3 years. Patients younger than 35 with no-to-mild cartilage damage may benefit from MAT for relief of symptoms (survivorship 51.9% at 20.2 years), but patients and healthcare payers and providers should be aware of the high number of surgical re-interventions.

Outcome of patellofemoral arthroplasty, determinants for success.

The primary aim of this study is to document whether patellofemoral arthroplasty is a good treatment option for patellofemoral osteoarthritis and to identify prognostic outcome factors. Secondary aim is to investigate the influence of preoperative tibiofemoral osteoarthritis on the clinical outcome. From 2004 to 2010, 37 Avon patellofemoral prostheses were implanted in 32 patients. Clinical outcome was evaluated with five questionnaires: KOOS, Kujala, VAS, OKS and Satisfaction Score. Radiographs were analyzed using the IWANO and Kellgren-Lawrence classification. To identify determinants of outcome, subgroups were examined according to sex, age, diagnosis, BMI and prior surgery. Patellofemoral arthroplasty is a valuable treatment for patellofemoral osteoarthritis. After prosthesis placement, KOOS, Kujala, VAS and OKS improved significantly (all p < 0.001). Patients with prior patellofemoral surgery were clinically worse (p < 0.05). Patients with preoperative Kellgren-Lawrence grade 2 tibiofemoral osteoarthritis had a significantly worse outcome compared to grade 1 (p < 0.05). Further research is necessary to determine whether patellofemoral arthroplasty is indicated in these patients.

Total knee arthroplasty at 15-17 years: does implant design affect outcome?

PURPOSE: A study was conducted to compare minimum 15-year survivorship and outcome of the Genesis I and II implants for total knee arthroplasty (TKA). METHODS: We retrospectively reviewed 245 consecutive TKA implanted between January 1995 and October 1997. Genesis I was implanted in 156 knees and Genesis II in 89 knees. RESULTS: At 15-17 years, 75 patients (31%) had died, 28 patients (11%) were lost to follow-up and 11 TKA were revised (4.6%), including ten Genesis I (6.4%) and one Genesis II (1.1%); 131 TKA (53%) were available for follow-up. Cumulative survivorship was 92.4% at 15.7 years. Survival in patients <69 years at surgery was lower (88.0%) compared with patients ≥69 years (98.5%; p = 0.023). In patients <69 years, Genesis I survival (84.3%) was worse compared with Genesis II (97.1%) (p = 0.018). Polyethylene (PE) Insert thickness ≤11 mm had significantly better survivorship (97.1%) compared with PE >11 mm (56.7%) (p < 0.0001) CONCLUSIONS: At a minimum of 15 years, the overall (92.4%) survivorship of Genesis TKA was good, with excellent (98.1%) survivorship of the Genesis II design. Revision rates were higher with Genesis I in the younger age group and with insert thickness >11 mm, possibly due to longer shelf life of less frequently used sizes.

Revisions of metal-on-metal hip resurfacing: lessons learned and improved outcome.

This retrospective, consecutive case series of a single surgeon performed between 2001 and 2010 assesses the outcome following revision of metal-on-metal hip resurfacing arthroplasties (N = 113). Mean time to revision was 31 months (0-101) after primary hip resurfacing. Malpositioning of the components with associated wear-induced soft tissue fluid collections was the most frequent factor leading to failure of a hip resurfacing arthroplasty. The mid-term outcome of the revisions was satisfactory; complications occurred in 11 patients (9.7%). Six of these patients underwent a re-revision.