Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs. The obstacles are compounded for RCTs of high-risk medical devices by extra costs related to the interventional procedure that is needed to implant the device, challenges with willingness to randomize patients throughout a trial, and difficulties in ensuring proper blinding even with sham procedures. One strategy that may help is to promote the wider use of simpler and more streamlined RCTs using data that are collected routinely during healthcare delivery. Recent large simple RCTs have successfully compared the performance of drugs and of high-risk medical devices, against alternative treatments; they enrolled many patients in a short time, limited costs, and improved efficiency, while also achieving major impact. From a task conducted within the CORE-MD project, we report from our combined experience of designing and conducting large pharmaceutical trials during the COVID-19 pandemic, and of planning and coordinating large registry-based RCTs of cardiovascular devices. We summarize the essential principles and utility of large simple RCTs, likely applicable to all interventions but especially in order to promote their wider adoption to evaluate new medical devices.@en

Background
The ring-augmented Roux-en-Y gastric bypass (raRYGB) has been reported to result in higher long-term weight loss compared to regular Roux-en-Y gastric bypass (RYGB). However, the type of ring used varied within studies, leading to heterogeneity in reported results. Therefore, this study compares the 5-year results of RYGB with and without ring augmentation using a specific prefabricated gastric ring.

Methods
All consecutive patients from a single center who received primary raRYGB between June 1, 2016, and May 31, 2018, with complete 5-year follow-up data were included and compared to a propensity score matched cohort receiving RYGB in the same period from the Dutch Audit for Treatment of Obesity. To ensure fair effect estimation of placing a ring, only RYGB procedures with alimentary and biliopancreatic limb lengths similar to those of the raRYGB were considered eligible. The primary outcome was percentage total weight loss (%TWL). Secondary outcomes included recurrent weight gain (RWG), obesity complication improvement, and complications.

Results
In total, 592 matched patients were analyzed. raRYGB was associated with higher %TWL at 5 years (31.5% versus 28.0%, β = 3.59, 95% CI [2.09–5.09], p < 0.01) and lower odds on RWG (odds ratio = 0.56, 95% CI [0.38–0.83], p < 0.01). Improvement of obesity complications and short-term complication rates were comparable in both groups. After 5 years, 13 patients (4%) had experienced ring-related complications needing reoperation.

Conclusions
At 5 years, raRYGB was associated with higher %TWL and lower odds on RWG. The occurrence of ring-related complications was limited.@en

Following the publication of the original article [1], we were notified that the name of the 10 ^th author was incorrectly tagged in the article’s XML. <GivenName>Perla</GivenName> <GivenName>J.</GivenName> <GivenName>Marang-van</GivenName> <Particle>de</Particle> <FamilyName>Mheen</FamilyName> <GivenName>Perla</GivenName> <GivenName>J.</GivenName> <FamilyName>Marang-van de Mheen</FamilyName> The original article has now been corrected.

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Background and purpose — The amount of information publicly available from arthroplasty registries is large but could be used more effectively. This project aims to improve the knowledge concerning existing registries to facilitate access, transparency, harmonization, and reporting. Methods — Within the International Society of Arthroplasty Registries (ISAR) we aimed at developing, testing, adopting, and making publicly available a short, standardized registry description with items considered relevant for stakeholders using a cross-sectional study survey. Items were chosen based on a literature review and expert advice, selected by 9 ISAR working group members, tested iteratively in 3 registries, and commented upon by 4 external experts. All 29 ISAR member registries as of July 2023 were invited to participate in the project. Results — Included items covered general descriptive information regarding registries, information related to governance, outcomes, data quality, data access, and registry production. The template was adopted, completed, and made publicly available by 25 of the 29 registries. Of those, 2/3 were national registries. 23 captured both hip and knee arthroplasties and 10 captured shoulder arthroplasties. Most registries had public reporting of data quality, methods, and results. Data was accessible in all but 2 registries, mainly as aggregated data. Important items relevant to registry quality for researchers to consistently indicate in scientific papers include scope, inclusion criteria, outcomes definitions, coverage/completeness, and validation processes. Conclusion — This ISAR initiative implemented a short, standardized description to facilitate appropriate use of orthopedic registry data worldwide relevant for a diverse group of stakeholders including researchers, industry, public health and regulatory agencies.

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For author Perla J. Marang-van de Mheen, the name tagging in the XML is incorrect. The author given name should be “Perla J.”, and the author family name should be “Marang-van de Mheen”.@en

Background: Orthopaedic Data Evaluation Panel (ODEP) ratings of total hip (TH) and total knee (TK) implants are informative for assessing implant performance. However, the validity of ODEP ratings across multiple registries is unknown. Therefore, we aimed to assess, across multiple registries, whether TH and TK implants with a higher ODEP rating (i.e., an A* rating) have lower cumulative revision risks (CRRs) than those with a lower ODEP rating (i.e., an A rating) and the extent to which A* and A-rated implants would be A*-rated on the basis of the pooled registries’ CRR. Methods: Implant-specific CRRs at 3, 5, and 10 years that were reported by registries were matched to ODEP ratings on the basis of the implant name. A meta-analysis with random-effects models was utilized for pooling the CRRs. ODEP benchmark criteria were utilized to classify these pooled CRRs. Results: A total of 313 TH cups (54%), 356 TH stems (58%), 218 TH cup-stem combinations (34%), and 68 TK implants (13%) with unique brand names reported by registries were matched to an ODEP rating. Given the low percentage that matched, TK implants were not further analyzed. ODEP-matched TH implants had lower CRRs than TH implants without an ODEP rating at all follow-up time points, although the difference for TH stems was not significant at 5 years. No overall differences in CRRs were found between A* and A-rated TH implants, with the exception of TH cup-stem combinations, which demonstrated a significantly lower CRR for A*A*-rated cup-stem combinations at the 3-year time point. Thirty-nine percent of A*-rated cups and 42% of A*-rated stems would receive an A* rating on the basis of the pooled registries’ CRR at 3 years; however, 24% of A-rated cups and 31% of A-rated stems would also receive an A* rating, with similar findings demonstrated at longer follow-up. Conclusions: At all follow-up time points, ODEP-matched TH implants had lower CRRs than TH implants without an ODEP rating. Given that the performance of TH implants varied across countries, registries should first validate ODEP ratings with use of country-specific revision data to better guide implant selection in their country. Data source transparency and the use of revision data from multiple registries would strengthen the ODEP benchmarks.

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The use of MRI and arthroscopy are considered low-value care in most patients with degenerative knee disease. To reduce these modalities, there have been multiple efforts to increase awareness. Reductions have been shown for general hospitals (GH), but it is unclear whether this may be partly explained by a shift of patients receiving these modalities in independent treatment centers (ITCs). The aims of this study were to assess (i) whether the trend in use of MRI and arthroscopy in patients with degenerative knee disease differs between ITCs and GH, and (ii) whether the Dutch efforts to raise awareness on these recommendations were associated with a change in the trend for both types of providers. All patients insured by a Dutch healthcare insurer aged ≥50 years with a degenerative knee disease who were treated in a GH or ITC between July 2014 and December 2019 were included. Linear regression was used with the quarterly percentage of patients receiving an MRI or knee arthroscopy weighted by center volume, as the primary outcome. Interrupted time-series analysis was used to evaluate the effect of the Dutch efforts to raise awareness. A total of 14 702 patients included were treated in 90 GHs (n = 13 303, 90.5%) and 29 ITCs (n = 1399, 9.5%). Across the study period, ITCs on an average had a 16% higher MRI use (P <. 001) and 9% higher arthroscopy use (P =. 003). MRI use did not change in both provider types, but arthroscopy use significantly decreased and became stronger in ITCs (P =. 01). The Dutch efforts to increase awareness did not significantly influence either MRI or arthroscopy use in ITCs (P =. 55 and P =. 84) and GHs (P =. 13 and P =. 70). MRI and arthroscopy uses were higher in ITCs than GHs. MRI use did not change significantly among patients ≥ 50 years with degenerative knee disease in both provider types between 2014 and 2019. MRI- and arthroscopy use decreased with ITCs on average having higher rates for both modalities, but also showing a stronger decrease in arthroscopy use. The Dutch efforts to increase awareness did not accelerate the already declining trend in the Netherlands.

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Background and purpose — Different marker-selection methods are applied to represent implant and tibial seg-ments in radiostereometric analysis (RSA) studies of total knee arthroplasty (TKA). Either a consistent set of markers throughout subsequent RSA examinations (“consistent-marker method”) is used or all available markers at each follow-up (“all-marker method”). The aim of this secondary analysis was to compare marker-selection methods on individual and group level TKA migration results. Methods — Data from a randomized RSA study with 72 patients was included. Tibial baseplate migration was evalu-ated at 3 months, 1, 2, and 5 years postoperatively with both marker-selection methods. Additionally, migration was calculated using 5 fictive points, either plotted based on the consistent set of markers or all available markers. Results — Migration could be calculated with both marker-selection methods for 248 examinations. The same prosthesis and bone markers (n = 136), different prosthesis markers (n = 71), different bone markers (n = 21), or different prosthesis and bone markers (n = 20) were used. The mean difference in maximum total point motion (MTPM) between all examinations was 0.02 mm, 95% confidence interval –0.26 to 0.31 mm. 5 implants were classified as continuously migrating with the consistent-marker method versus 6 implants (same 5 plus one additional implant) with the all-marker method. Using fictive points, fewer implants were classified as continuously migrating in both marker-selection methods. Differences between TKA groups in mean MTPM were comparable with both marker-selection methods, also when fictive points were used. Conclusion — Estimated group differences in mean MTPM were similar between marker-selection methods, but individual migration results differed. The latter has implications when classifying implants for estimated risk of future loosening.

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The name of author Perla J. Marang-van de Mheen was tagged incorrectly. “Perla J.” should be tagged as the given name and “Marang-van de Mheen” should be tagged as the family name.

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Background: Loosening is a major cause for failure of total hip and total knee arthroplasties (THAs/TKAs). Preemptive diagnostics of asymptomatic loosening could open strategies to prevent gross loosening. A multitude of biomarkers may discriminate between loosened and stable implants, but it is unknown which have the best performance. The present systematic review aimed to assess which biomarkers have shown the most promising results in discriminating between stable and aseptic loosened THAs and TKAs.

Methods: PubMed, Embase, Web of Science, Cochrane Library, and Academic Search Premier were systematically searched up to January 2020 for studies including THA/TKA and biomarkers to assess loosening. Two reviewers independently screened records, extracted data, and assessed the risk of bias using the ICROMS tool to classify the quality of the studies.

Results: Twenty-eight (three high-quality) studies were included, reporting on a median of 48 patients (interquartile range 28–69). Serum and urine markers were evaluated in 22 and 10 studies, respectively. Tumor necrosis factor α and osteocalcin were significantly higher in loosened compared with stable implants. Urinary N-terminal telopeptide had significantly elevated levels in loosened prostheses.

Conclusion: Several serum and urine markers were promising in discriminating between loosened and stable implants. We recommend future studies to evaluate these biomarkers in a longitudinal fashion to assess whether progression of loosening is associated with a change in these biomarkers. In particular, high-quality studies assessing the usability of these biomarkers are needed.

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Introduction: Changes in health-related quality of life (HRQoL) during the diagnostic and treatment trajectory of high-grade extremity soft-tissue sarcoma (eSTS) has rarely been investigated for adults (18–65 y) and the elderly (aged ≥65 y), despite a potential variation in challenges from diverse levels of physical, social, or work-related activities. This study assesses HRQoL from time of diagnosis to one year thereafter among adults and the elderly with eSTS. Methods: HRQoL of participants from the VALUE-PERSARC trial (n = 97) was assessed at diagnosis and 3, 6 and 12 months thereafter, utilizing the PROMIS Global Health (GH), PROMIS Physical Function (PF) and EQ-5D-5L. Results: Over time, similar patterns were observed in all HRQoL measures, i.e., lower HRQoL scores than the Dutch population at baseline (PROMIS-PF:46.8, PROMIS GH-Mental:47.3, GH-Physical:46.2, EQ-5D-5L:0.76, EQ-VAS:72.6), a decrease at 3 months, followed by an upward trend to reach similar scores as the general population at 12 months (PROMIS-PF:49.9, PROMIS GH-Physical:50.1, EQ-5D-5L:0.84, EQ-VAS:81.5), except for the PROMIS GH-Mental (47.5), where scores remained lower than the general population mean (T = 50). Except for the PROMIS-PF, no age-related differences were observed. Conclusions: On average, eSTS patients recover well physically from surgery, yet the mental component demonstrates no progression, irrespective of age. These results underscore the importance of comprehensive care addressing both physical and mental health.@en

Introduction
Different limb lengths are used in Roux-en-Y gastric bypass (RYGB) surgery, as there is no consensus which limb length strategy has the best outcomes. The biliopancreatic limb (BPL) is thought to play an important role in achieving weight loss and associated comorbidity resolution. The objective of this study was to assess the impact of a longer BPL on weight loss and comorbidity improvement at 5 years after primary RYGB.

Methods
All patients aged ≥ 18 years undergoing primary RYGB between 2014–2017 with registered follow-up 5 years after surgery were included. Long BPL was defined as BPL ≥ 100 cm and short BPL as BPL < 100 cm. The primary outcome was achieving at least 25% total weight loss (TWL) at 5 years. Secondary outcomes included absolute %TWL and improvement of comorbidities. A propensity score matched logistic and linear regression was used to estimate the difference in outcomes between patients with long and short BPL.

Results
At 5 years, long BPL had higher odds to achieve ≥ 25% TWL (odds ratio (OR) 1.19, 95% confidence interval (CI) [1.01 – 1.41]) and was associated with 1.26% higher absolute TWL (β = 1.26, 95% CI [0.53 – 1.99]). Furthermore, long BPL was more likely to result in improved diabetes mellitus (OR = 2.17, 95% CI [1.31 – 3.60]) and hypertension (OR = 1.45, 95% CI [1.06 – 1.99]).

Conclusion
Patients undergoing RYGB with longer BPL achieved higher weight loss and were more likely to achieve improvement of comorbidities at 5 years.@en

Background: A pectoralis major (PM) transfer is a viable treatment option for patients with scapular winging due to long thoracic nerve (LTN) palsy not responding to nonsurgical management. However, the long-term outcomes remain unknown. Therefore, the purpose of this study was to evaluate the long-term outcome of shoulder function (ie, minimum follow-up of 10 years) and quality-of-life (QoL) of patients treated for scapular winging due to LTN palsy with a PM transfer. Methods: This observational cohort study included 15 patients (16 shoulders) who underwent PM transfer, using a tendoachilles allograft, between 1995 and 2012. Shoulder forward flexion and abduction were analyzed preoperatively, 1 year after surgery and at the final follow-up. SF-36 component scores (physical component summary (PCS) and mental component summary (MCS)) were used to evaluate the QoL. Results: Shoulder forward flexion and abduction measured in degrees improved from 86 (SD 14.5) and 82 (SD 33.8) preoperatively to 140 (SD 27.3) and 138 (31.3) at 1 year postoperatively. After a median follow-up of 17 years, mean shoulder functions were slightly lower than at 1 year postoperatively, but still better than preoperative function, ie, forward flexion 121 (SD 41.9) and abduction 122 (SD 44.5). The mean PCS score at the final follow-up was 41.9 (SD 9.7), and the mean MCS score was 49.9 (SD 12.5). Better shoulder function at the final follow-up was significantly associated with higher QoL in terms of PCS scores (P = .023), but not MCS scores (P = .287). Conclusion: The results of the present study indicate that PM transfer augmented with an achilles tendon allograft for scapular winging due to LTN palsy leads to functional improvements that persist in long term. These functional improvements likely translate to better QoL based on their association.

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Background:Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome measures (PROMs) reflect the patients' perspective of their functional status, pain, and overall health after TKA. The aim of this study was to evaluate the association between tibial implant migration and change in postoperative PROMs and clinical scores, using data pooled from long-Term follow-up RSA studies.Methods:Individual implant migration data were collected from 5 randomized RSA studies, including a total of 300 patients with 6 distinct TKA implant designs (all Stryker). Tibial implant migration (maximum total point motion [MTPM]) was evaluated with RSA at 3 months, 1 year, and 2, 5, 7, and 10 years postoperatively. The Knee Society Score (KSS)-Knee and KSS-Function and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales were collected in all studies at the same follow-up times. Linear mixed-effects models, with adjustment for TKA implant design and patient characteristics, were used to analyze the data. The 3-month follow-up visit was used as the baseline to assess the association between implant migration and PROMs across the 10-year follow-up.Results:No association between tibial implant migration and change in KSS-Knee (p = 0.384), KSS-Function (p = 0.737), KOOS-Symptoms (p = 0.398), KOOS-Pain (p = 0.699), KOOS-Activities of Daily Living (p = 0.205), KOOS-Sport and Recreation (p = 0.702), or KOOS-Quality of Life (p = 0.368) was found across the entire follow-up. Similar results were found when using the 2-year follow-up as the baseline, after which both cemented and uncemented implants are expected to have stabilized.Conclusions:Tibial baseplate migration was not associated with postoperative worsening in PROMs or clinical scores in patients who underwent TKA. These findings suggest that implant migration, as measured with RSA, measures a different parameter (i.e., implant-bone fixation) than PROMs (i.e., patient perception) and clinical scores. Therefore, to assess the performance and safety of TKA implant designs, RSA and PROMs cannot be used interchangeably during the postoperative follow-up of patients and evaluation of the fixation of knee implants.Level of Evidence:Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

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Introduction: Risk prediction models (RPM) can help soft-tissue sarcoma(STS) patients and clinicians make informed treatment decisions by providing them with estimates of (disease-free) survival for different treatment options. However, it is unknown how RPMs are used in the clinical encounter to support decision-making. This study aimed to understand how a PERsonalised SARcoma Care (PERSARC) RPM is used to support treatment decisions and which barriers and facilitators influence its use in daily clinical practice. Methods: A convergent mixed-methods design is used to understand how PERSARC is integrated in the clinical encounter in three Dutch sarcoma centers. Data were collected using qualitative interviews with STS patients (n = 15) and clinicians (n = 8), quantitative surveys (n = 50) and audiotaped consultations (n = 30). Qualitative data were analyzed using thematic analysis and integrated with quantitative data through merging guided by the SEIPS model. Results: PERSARC was generally used to support clinicians’ proposed treatment plan and not to help patients weigh available treatment options. Use of PERSARC in decision-making was hampered by clinician's doubts about whether there were multiple viable treatment options,the accuracy of risk estimates, and time constraints. On the other hand, use of PERSARC facilitated clinicians to estimate and communicate the expected benefit of adjuvant therapy to patients. Conclusion: PERSARC was not used to support informed treatment decision-making in STS patients. Integrating RPMs into clinical consultations requires acknowledgement of their benefits in facilitating clinicians' estimation of the expected benefit of adjuvant therapies and information provision to patients, while also considering concerns regarding RPM quality and treatment options' viability.

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Background: Many patients suffer from osteoarthritis (OA) in multiple joints, possibly resulting in multiple joint arthroplasties (MJAs). Primarily, we determined the cumulative incidence (C_in) of MJA in hip and knee joints up to 10 years. Secondly, we calculated the mean time between the first and subsequent joint arthroplasty, and evaluated the different MJA trajectories. Lastly, we compared patient characteristics and outcomes (functionality and pain) after surgery between MJA patients and single hip arthroplasty or knee arthroplasty (HA and KA) patients. Methods: Primary index (first) HA or KA for OA were extracted from the Dutch Arthroplasty Register. The 1, 2, 5, and 10-year C_in (including competing risk death) of MJA, mean time intervals, and MJA-trajectories were calculated and stratified for primary index HA or KA. Sex, preoperative age, and body mass index were compared using ordinal logistic regression. Outcomes, measured preoperatively, 3, 6, and 12 months postoperatively (function: Hip Disability or Knee Injury and OA Outcome Score; Pain: Numerical Rating Scale), were compared using linear regression. Results: A total of 140,406 HA-patients and 140,268 KA-patients were included. One, 2, 5, and 10-year C_in for a second arthroplasty were respectively 8.9% [95% confidence interval (CI): 8.7 to 9.0], 14.3% [95% CI: 14.1 to 14.5], 24.0% [95% CI: 23.7 to 24.2], and 32.7% [95% CI: 32.2 to 33.1] after index HA, and 9.5% [95% CI: 9.4 to 9.7], 16.0% [95% CI: 15.9 to 16.2], 26.4% [95% CI: 26.1 to 26.6], and 35.8% [95% CI: 35.4 to 36.3] after index KA. The 10-year C_in for > 2 arthroplasties were small in both the index HA and KA groups. Time-intervals from first to second, third, and fourth arthroplasty were 26 [95% CI: 26.1 to 26.7], 47 [95% CI: 46.4 to 48.4], and 58 [95% CI: 55.4 to 61.1] months after index HA, and 26 [95% CI: 25.9 to 26.3], 52 [95% CI: 50.8 to 52.7], and 61 [95% CI: 58.3 to 63.4] months after index KA. There were 83% of the second arthroplasties placed in the contralateral cognate joint (ie, knee or hip). Differences in postoperative functionality and pain between MJAs and single HAs and KAs were small. Conclusions: The 10-year C_in showed that about one-third of patients received a second arthroplasty after approximately 2 years, with the majority in the contralateral cognate joint. Few patients received > 2 arthroplasties within 10 years. Being a women, having a higher body mass index, and being younger increased the odds of MJA. Postoperative outcomes were slightly negatively affected by MJA.

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Introduction: Bariatric surgery aims for optimal patient outcomes, often evaluated through the percentage total weight loss (%TWL). Quality registries employ funnel plots for outcome comparisons between hospitals. However, funnel plots are traditionally used for dichotomous outcomes, requiring %TWL to be dichotomized, potentially limiting feedback quality. This study evaluates whether a funnel plot around the median %TWL has better discriminatory performance than binary funnel plots for achieving at least 20% and 25% TWL. Methods: All hospitals performing bariatric surgery were included from the Dutch Audit for Treatment of Obesity. A funnel plot around the median was constructed using 5-year %TWL data. Hospitals positioned above the 95% control limit were colored green and those below red. The same hospitals were plotted in the binary funnel plots for 20% and 25% TWL and colored according to their performance in the funnel plot around the median. We explored the hospital’s procedural mix in relation to %TWL performance as possible explanatory factors. Results: The median-based funnel plot identified four underperforming and four outperforming hospitals, while only one underperforming and no outperforming hospitals were found with the binary funnel plot for 20% TWL. The 25% TWL binary funnel plot identified two underperforming and three outperforming hospitals. The proportion of sleeve gastrectomies performed per hospital may explain part of these results as it was negatively associated with median %TWL (β = − 0.09, 95% confidence interval [− 0.13 to − 0.04]). Conclusion: The funnel plot around the median discriminated better between hospitals with significantly worse and better performance than funnel plots for dichotomized %TWL outcomes. Graphical Abstract: (Figure presented.)

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Background and purpose — Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as “outlier.” We aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants. Methods — The CORE-MD tool, an automated web scraper tool, was used to collect safety notices related to TKA implants on 13 national Ministries of Health websites and regulatory agencies. Safety notices were defined accord-ing to the Medical Device Regulation (MDR) as “a com-munication sent by a manufacturer to users or customers in relation to a field safety corrective action.” Identified TKA outliers, defined as having a significantly higher revision risk than other comparable TKA implants, were extracted from registry reports. Results — 787 safety notices for 38 TKA implants and 35 TKA outliers were identified, together identifying 47 unique TKA implants. 26 (55%) TKA implants had safety notices and were also outliers, 12 (26%) TKA implants had only safety notices, and 9 (19%) were outliers only. TKA implants with safety notices only had similar types of problems to TKA outliers with safety notices, with “Manufac-turing/Packaging/Shipping” problems being most frequent (44%). Cumulative revision risks (1/5/10 years) were lower for TKA implants with safety notices only than for TKA out-liers with safety notices. Conclusion — 55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance.

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