Improvements in Quality, Safety and Costs Associated with Use of Implant Registries Within a Health System.

BACKGROUND: Clinical quality registries (CQRs) are intended to enhance quality, safety, and cost reduction using real-world data for a self-improving health system. Starting in 2001, Kaiser Permanente established several medical device CQRs as a quality improvement initiative. This report examines the contributions of these CQRs on improvement in health outcomes, changes in clinical practice, and cost-effectiveness over the past 20 years. METHODS: Eight implant registries were instituted with standardized collection from the electronic health record and other institutional data sources of patient characteristics, medical comorbidities, implant attributes, procedure details, surgical techniques, and outcomes (including complications, revisions, reoperations, hospital readmissions, and other utilization measures). A rigorous quality control system is in place to improve and maintain the quality of data. Data from the Implant Registries form the basis for multiple quality improvement and patient safety initiatives to minimize variation in care, promote clinical best practices, facilitate recalls, perform benchmarking, identify patients at risk, and construct reports about individual surgeons. RESULTS: Following the inception of the Implant Registries, there was an observed (1) reduction in opioid utilization following orthopedic procedures, (2) reduction in use of bone morphogenic protein during lumbar fusion allowing for cost savings, (3) reduction in allograft for anterior cruciate ligament reconstruction and subsequent decrease in organizationwide revision rates, (4) cost savings through expansion of same-day discharge programs for joint arthroplasty, (5) increase in the use of cement fixation in the hemiarthroplasty treatment of hip fracture, and (6) organizationwide discontinuation of an endograft device associated with a higher risk for adverse outcomes following endovascular aortic aneurysm repair. CONCLUSION: The use of Implant Registries within our health system, along with clinical leadership and organizational commitment to a learning health system, was associated with improved quality and safety outcomes and reduced costs. The exact mechanisms by which such registries affect health outcomes and costs require further study.

Unipolar Hemiarthroplasty, Bipolar Hemiarthroplasty, or Total Hip Arthroplasty for Hip Fracture in Older Individuals.

BACKGROUND: Practice patterns regarding the use of unipolar hemiarthroplasty, bipolar hemiarthroplasty, and total hip arthroplasty (THA) for femoral neck fractures in older patients vary widely. This is due in part to limited data stipulating the specific circumstances under which each form of arthroplasty provides the most predictable outcome. The purpose of this study was to investigate the patient characteristics for which unipolar hemiarthroplasty, bipolar hemiarthroplasty, or THA might be preferable due to a lower risk of all-cause revision. METHODS: A U.S. health-care system's hip fracture registry was used to identify patients ≥60 years old who underwent unipolar hemiarthroplasty, bipolar hemiarthroplasty, or THA for hip fracture from 2009 through 2021. Unipolar and bipolar hemiarthroplasty were compared with THA within patient subgroups defined by age (60 to 79 versus ≥80 years) and American Society of Anesthesiologists (ASA) classification (I or II versus III); patients with an ASA classification of IV or higher were excluded. Multivariable Cox proportional hazard regression analysis was used to evaluate all-cause revision risk while adjusting for confounders, with mortality considered as a competing risk. RESULTS: There were 14,277 patients in the final sample (median age, 82 years; 70% female; 80% White; 69% with an ASA classification of III; median follow-up, 2.7 years), and the procedures included 7,587 unipolar hemiarthroplasties, 5,479 bipolar hemiarthroplasties, and 1,211 THAs. In the multivariable analysis of all patients, both unipolar (hazard ratio [HR] = 2.15, 95% confidence interval [CI] = 1.48 to 3.12; p < 0.001) and bipolar (HR = 1.92, 95% CI = 1.31 to 2.80; p < 0.001) hemiarthroplasty had higher revision risks than THA. In the age-stratified multivariable analysis of patients aged 60 to 79 years, both unipolar (HR = 2.17, 95% CI = 1.42 to 3.34; p = 0.004) and bipolar (HR = 1.69, 95% CI = 1.08 to 2.65; p = 0.022) hemiarthroplasty also had higher revision risks than THA. In the ASA-stratified multivariable analysis, patients with an ASA classification of I or II had a higher revision risk after either unipolar (HR = 3.52, 95% CI = 1.87 to 6.64; p < 0.001) or bipolar (HR = 2.31, 95% CI = 1.19 to 4.49; p = 0.013) hemiarthroplasty than after THA. No difference in revision risk between either of the hemiarthroplasties and THA was observed among patients with an age of ≥80 years or those with an ASA classification of III. CONCLUSIONS: In this study of hip fractures in older patients, THA was associated with a lower risk of all-cause revision compared with unipolar and bipolar hemiarthroplasty among patients who were 60 to 79 years old and those who had an ASA classification of I or II. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Can Dual Mobility Cups Reduce Revision and Dislocation Risks? An Analysis of 107,528 Primary Total Hip Arthroplasties in the United States.

BACKGROUND: Dual mobility acetabular cups (DMC) were designed to increase the effective femoral head size and improve stability with the goal of reducing revision risk at the potential cost of polyethylene thickness. We sought to evaluate revision risk following primary elective total hip arthroplasty with DMC compared to highly cross-linked polyethylene (XLPE). METHODS: A cohort study was conducted using data from a Kaiser Permanente's total joint arthroplasty registry. Patients ≥18 years who underwent primary elective total hip arthroplasty using DMC, unipolar Metal-on-XLPE (MoXLPE), or unipolar Ceramic-on-XLPE (CoXLPE) were identified (2010 to 2021). The final sample comprised 2,219 DMC, 48,251 MoXLPE, and 57,058 CoXLPE. Multiple Cox proportional hazard regressions were used to evaluate aseptic revision and any dislocation regardless of revision within 6 years follow-up. RESULTS: In adjusted analyses, no differences in aseptic revision risk were observed for MoXLPE (hazard ratio [HR] = 1.04, 95% confidence interval [CI] = 0.72 to 1.51) or CoXLPE (HR = 0.98, 95% CI = 0.69 to 1.40) compared to DMC. No differences in dislocation risk were observed for MoXLPE (HR = 1.42, 95% CI = 0.93 to 2.15) or CoXLPE (HR = 1.25, 95% CI = 0.84 to 1.87) compared to DMC. CONCLUSIONS: In a US-based cohort, 6-year aseptic revision risk of DMC was similar to metal or ceramic femoral head unipolar constructs. Furthermore, no difference in dislocation risk was observed. Continued longer-term follow-up may reveal if there is a reduced risk of dislocation that comes at the cost of increased late revision. LEVEL OF EVIDENCE: Level III.

The use of antibiotic-loaded bone cement and systemic antibiotic prophylactic use in 2,971,357 primary total knee arthroplasties from 2010 to 2020: an international register-based observational study among countries in Africa, Europe, North America, and Oceania.

BACKGROUND AND PURPOSE: Antibiotic-loaded bone cement (ALBC) and systemic antibiotic prophylaxis (SAP) have been used to reduce periprosthetic joint infection (PJI) rates. We investigated the use of ALBC and SAP in primary total knee arthroplasty (TKA). PATIENTS AND METHODS: This observational study is based on 2,971,357 primary TKAs reported in 2010-2020 to national/regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, the Netherlands, New Zealand, Norway, Romania, South Africa, Sweden, Switzerland, the UK, and the USA. Aggregate-level data on trends and types of bone cement, antibiotic agents, and doses and duration of SAP used was extracted from participating registries. RESULTS: ALBC was used in 77% of the TKAs with variation ranging from 100% in Norway to 31% in the USA. Palacos R+G was the most common (62%) ALBC type used. The primary antibiotic used in ALBC was gentamicin (94%). Use of ALBC in combination with SAP was common practice (77%). Cefazolin was the most common (32%) SAP agent. The doses and duration of SAP used varied from one single preoperative dosage as standard practice in Bolzano, Italy (98%) to 1-day 4 doses in Norway (83% of the 40,709 TKAs reported to the Norwegian arthroplasty register). CONCLUSION: The proportion of ALBC usage in primary TKA varies internationally, with gentamicin being the most common antibiotic. ALBC in combination with SAP was common practice, with cefazolin the most common SAP agent. The type of ALBC and type, dose, and duration of SAP varied among participating countries.

Association Between Race/Ethnicity and 90-Day Emergency Department Visits in Patients Undergoing Elective Total Knee Arthroplasty or Total Hip Arthroplasty in a Universally Insured Population.

BACKGROUND: Research has identified disparities in returns to care by race/ethnicity following primary total joint arthroplasty. We sought to identify risk factors for 90-day emergency department (ED) returns following primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for these populations. METHODS: Black, Hispanic, and non-Hispanic White patients who underwent elective primary unilateral TKA and THA in an integrated US healthcare system were identified. Risk factors for 90-day postoperative ED visits including patient demographics, household income and education, comorbidities, preoperative healthcare utilization, and copay data were identified with multivariable logistic regression. RESULTS: Postoperative 90-day ED visits occurred in 13.3% of 79,565 TKA patients (17.2% Black; 14.9% Hispanic; 12.5% White) and 11.0% of THA patients (13.4% Black; 12.1% Hispanic; 10.7% White). Across racial/ethnic categories, patients who had an ED visit within 1 year of their TKA or THA date were more likely to have a 90-day ED return. Shared risk factors for TKA patients were chronic lung disease and outpatient utilization (25th and 75th percentile), while peripheral vascular disease was a shared risk factor for THA patients. Risk factors for multiple races of TKA and THA patients included depression, drug abuse, and psychosis. Prior copay for White (TKA) and Hispanic (TKA and THA) patients was protective, while preoperative primary care was protective for Black THA patients. CONCLUSION: Future strategies to reduce postoperative ED returns should include directed patient outreach for patients who had ED visits and mental health in the year prior to TKA and THA. LEVEL OF EVIDENCE: III.

Association between same-day discharge shoulder arthroplasty and risk of adverse events in patients with American Society of Anesthesiologists classification ≥3: a cohort study.

BACKGROUND: Same-day discharge for shoulder arthroplasty (SA) is well-supported in the literature; however, most studies have focused on healthier patients. Indications for same-day discharge SA have expanded to include patients with more comorbidities, but safety of same-day discharge in this population remains unknown. We sought to compare outcomes following same-day discharge vs. inpatient SA in a cohort of patients considered higher risk for adverse events, defined as an American Society of Anesthesiologists (ASA) classification of ≥3. METHODS: Data from Kaiser Permanente's SA registry were utilized to conduct a retrospective cohort study. All patients with an ASA classification of ≥3 who underwent primary elective anatomic or reverse SA in a hospital from 2018 to 2020 were included. The exposure of interest was in-hospital length of stay: same-day discharge vs. ≥1-night hospital inpatient stay. The likelihood of 90-day post-discharge events, including emergency department (ED) visit, readmission, cardiac complication, venous thromboembolism, and mortality, was evaluated using propensity score-weighted logistic regression with noninferiority testing using a margin of 1.10. RESULTS: The cohort included a total of 1814 SA patients, of whom 1005 (55.4%) had same-day discharge. In propensity score-weighted models, same-day discharge was not inferior to an inpatient stay SA regarding 90-day readmission (odds ratio [OR] = 0.64, one-sided 95% upper bound [UB] = 0.89) and overall complications (OR = 0.67, 95% UB = 1.00). We lacked evidence in support of noninferiority for 90-day ED visit (OR = 0.96, 95% UB = 1.18), cardiac event (OR = 0.68, 95% UB = 1.11), or venous thromboembolism (OR = 0.91, 95% UB = 2.15). Infections, revisions for instability, and mortality were too rare to evaluate using regression analysis. CONCLUSIONS: In a cohort of over 1800 patients with an ASA of ≥3, we found same-day discharge SA did not increase the likelihood of ED visits, readmissions, or complications compared with an inpatient stay, and same-day discharge was not inferior to an inpatient stay with regard to readmissions and overall complications. These findings suggest that it is possible to expand indications for same-day discharge SA in the hospital setting.

Risk of Aseptic Revision and Periprosthetic Fracture Following Bipolar Versus Unipolar Hemiarthroplasty.

Hemiarthroplasty is currently the most common treatment for displaced femoral neck fractures in the elderly. While bipolar hemiarthroplasty was developed to reduce the risk of acetabular erosion that is associated with traditional unipolar hemiarthroplasty, meta-analyses have reported similar outcomes for bipolar and unipolar hemiarthroplasty devices. The primary objective of this study was to evaluate the risks of aseptic revision and periprosthetic fracture following bipolar versus unipolar hemiarthroplasty in a large integrated health-care system in the United States. Methods: We conducted a retrospective cohort study using data from the hip fracture registry of an integrated health-care system. Patients aged ≥60 years who underwent hemiarthroplasty for hip fracture between 2009 and 2019 were included. The primary outcome measure was aseptic revision, and the secondary outcome measure was revision for periprosthetic fracture. Cause-specific Cox proportional hazards regression was performed, with mortality considered as a competing event. In the multivariable analysis, estimates were adjusted for potential confounders such as age, sex, race/ethnicity, body mass index, American Society of Anesthesiologists classification, femoral fixation, surgeon volume, type of anesthesia, and discharge disposition. Results: The study sample included 13,939 patients who had been treated with hemiarthroplasty by 498 surgeons at 35 hospitals. The mean follow-up time was 3.7 ± 2.9 years. The overall incidence of aseptic revision at 5 years following hemiarthroplasty was 2.8% (386). In the multivariable analysis controlling for potential confounders, bipolar hemiarthroplasty was associated with a lower risk of aseptic revision than unipolar hemiarthroplasty (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.59 to 0.94; p = 0.012). Rates of revision for periprosthetic fracture were similar between the bipolar and unipolar devices (HR, 0.79; 95% CI, 0.58 to 1.10; p = 0.16). Conclusions: In this study of hemiarthroplasty for hip fracture in elderly patients, bipolar designs were associated with a lower risk of aseptic revision than unipolar designs. In contrast to prior research, we did not find any difference in the risk of periprosthetic fracture between the 2 designs. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Risk for surgical interventions following endovascular aneurysm repair with Endologix AFX or AFX2 Endovascular AAA Systems compared with other devices.

OBJECTIVE: To evaluate the risk for 90-day returns to care and long-term subsequent surgical interventions after primary endovascular aneurysm repair (EVAR) with an Endologix AFX Endovascular AAA System compared with three other high-volume endograft devices. METHODS: We conducted a matched cohort study using data from Kaiser Permanente's Endovascular Stent Graft Registry. Patients aged ≥18 years who underwent primary EVAR for AAA in the health care system from January 1, 2011, to December 31, 2017, comprised the eligible study sample. The treatment group included patients who received an Endologix AFX or AFX2 device (n = 470). Patients who received one of three other high-volume endograft devices used within the health care system comprised the eligible comparison group (n = 2122). These patients were 2:1 propensity score matched without replacement to patients who received an Endologix device based on a number of patient and procedural characteristics. After the application of matching, conditional logistic regression was used to evaluate the likelihood for 90-day emergency department visit and readmission. Cause-specific Cox regression was used to evaluate the long-term risk of endoleak, graft revision, secondary reintervention (not including revision), conversion to open repair, and rupture during follow-up. Cox proportional hazards regression was used to evaluate the risk of mortality (overall and aneurysm related). RESULTS: The final matched study sample included 470 patients who received an Endologix AFX or AFX2 device and 940 patients who received a different high-volume device. compared with the other devices, AFX/AFX2 had a higher risk for type III endoleak (hazard ratio [HR], 38.79; 95% confidence interval [CI], 14.51-103.67), revision surgery >1 year after the primary EVAR (HR, 4.50; 95% CI, 3.10-6.54), rupture (HR, 6.52; 95% CI, 1.73-24.63), and aneurysm-related mortality (HR, 2.43; 95% CI, 1.32-4.47) was observed with the use of AFX/AFX2. CONCLUSIONS: In our matched cohort study, patients who received an Endologix AFX System during their primary EVAR had a higher risk for several adverse longitudinal outcomes, as well as aneurysm-related mortality, when compared with patients who received other high-volume devices. Patients who have received these devices should be monitored closely after EVAR.

Prolonged Opioid Usage Following Hip Fracture Surgery in Opioid-Naïve Older Patients.

BACKGROUND: While the risk of long-term dependence following the opioid treatment of musculoskeletal injury is often studied in younger populations, studies in older patients have centered on short-term risks such as oversedation and delirium. This study investigated prolonged opioid usage after hip fracture in older individuals, focusing on prevalence, risk factors, and changes over time. METHODS: In this retrospective cohort study of 47,309 opioid-naïve patients aged ≥ 60 years who underwent hip fracture surgery (2009 to 2020), outpatient opioid use was evaluated in 3 postoperative time periods: P1 (day 0 to 30 postsurgery); P2 (day 31 to 90); and P3 (day 91 to 180). The primary outcome was prolonged outpatient opioid use, defined as having one or more opioid prescriptions dispensed in all 3 time periods. RESULTS: The incidence of prolonged opioid usage among patients surviving to P3 was 6.3% (2,834 of 44,850). Initial prescription quantities decreased over time, as did the risk of prolonged opioid usage (from 8.0% in 2009 to 3.9% in 2019). In the multivariable analyses, risk factors for prolonged opioid usage included younger age, women, current/former smoking, fracture fixation (as compared to hemiarthroplasty), and anxiety. Prolonged opioid usage was less common among patients who were Asian or had a history of dementia. CONCLUSIONS: While prior research on the hazards of opioids in the elderly has focused on short-term risks such as oversedation and delirium, these findings suggest that prolonged opioid usage may be a risk for this older population as well. As initial prescription amounts have decreased, declines in prolonged opioid medication usage have also been observed.

An Interrupted Time Series Analysis Measuring the Impact of Research and Education on Clinical Practice: Decreasing Allograft Use in Young Patients Using a Registry to Track Outcomes.

BACKGROUND: We sought to evaluate whether allograft utilization for primary anterior cruciate ligament reconstruction (ACLR) within our health-care system changed following the implementation of an allograft reduction intervention and whether revision rates within the health-care system changed following the initiation of the intervention. METHODS: We conducted an interrupted time series study using data from Kaiser Permanente's ACL Reconstruction Registry. In our study, we identified 11,808 patients who were ≤21 years of age and underwent primary ACLR from January 1, 2007, through December 31, 2017. The pre-intervention period (15 quarters) was January 1, 2007, through September 30, 2010, and the post-intervention period (29 quarters) was October 1, 2010, through December 31, 2017. Poisson regression was used to evaluate trends over time in 2-year revision rates according to the quarter in which the primary ACLR was performed. RESULTS: Allograft utilization increased pre-intervention from 21.0% in 2007 Q1 to 24.8% in 2010 Q3. Utilization decreased post-intervention from 29.7% in 2010 Q4 to 2.4% in 2017 Q4. The quarterly 2-year revision rate increased from 3.0 to 7.4 revisions per 100 ACLRs pre-intervention and decreased to 4.1 revisions per 100 ACLRs by the end of the post-intervention period. Poisson regression found an increasing 2-year revision rate over time pre-intervention (rate ratio [RR], 1.03 [95% confidence interval (CI), 1.00 to 1.06] per quarter) and a decreasing rate over time post-intervention (RR, 0.96 [95% CI, 0.92 to 0.99]). CONCLUSIONS: In our health-care system, we saw a decrease in allograft utilization following the implementation of an allograft reduction program. During the same period, a decrease in the ACLR revision rate was observed. LEVEL OF EVIDENCE: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Identification of implant outliers in joint replacement registries.

Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace. Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance. A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports. Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices. Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement.

Single Wedge Femoral Stem Designs are Associated With a Higher Risk for Revision After Cementless Primary Total Hip Arthroplasty.

BACKGROUND: Cementless total hip arthroplasty (THA) femoral stems are the most commonly selected prostheses in the United States. Optimal stem geometry remains controversial with excellent survivorship reported for many designs. We compared cause-specific stem revision of single-wedge versus double-wedge designs from a multicenter US cohort. METHODS: Data from an integrated healthcare network's total joint replacement registry were used to conduct a cohort study. Primary elective cementless THAs were identified (2001 to 2018). Implant exposure groups were classified by design geometry using the system proposed by Khanuja et al. Type 1 single-wedge (n = 11,082) and type 2 double-wedge (n = 32,380) designs were compared, and other design types were excluded; the final study cohort comprised 43,462 THAs. Cause-specific multivariable Cox regressions were used to evaluate risk for revision due to infection or aseptic reasons, including loosening, instability, periprosthetic fracture, or other reasons. RESULTS: After adjustment for covariates, a higher aseptic revision risk was observed for type 1 when compared to type 2 designs (hazard ratio = 1.91, 95% confidence interval = 1.33-2.75). When looking at specific revision reasons, revision for aseptic loosening (hazard ratio = 3.46, 95% confidence interval = 2.24-5.34) was higher for type 1 versus type 2 designs. No differences were found for septic revision, instability, periprosthetic fracture, or revisions for other reasons. CONCLUSIONS: Type 1 single-wedge designs were found to have a higher risk of revision due to aseptic loosening relative to type 2 double-wedge designs. Femoral stem geometry should be considered when selecting a cementless femoral implant. LEVEL OF EVIDENCE: Level III.

Does Aseptic Revision Risk Differ for Primary Total Knee Arthroplasty Patients Who Have and Do not Have a Prior Primary or Revision Arthroplasty?

BACKGROUND: We sought to evaluate the risk of aseptic revision in total knee arthroplasty (TKA) patients who have and do not have a history of primary or revision arthroplasty of a different major joint. METHODS: We conducted a matched cohort study using data from Kaiser Permanente's arthroplasty registries. Patients who underwent primary unilateral TKA (index knee) were identified (2009-2018). Two matches based on exposure history were performed: (1) 33,714 TKAs with a history of primary arthroplasty of a different joint (contralateral knee, either hip, and/or either shoulder) were matched to 67,121 TKAs without an arthroplasty history and (2) 597 TKAs with a history of aseptic revision in a different joint were matched to 1,190 TKAs with a history of a prior arthroplasty in a different joint, but without any revision. After the matches were performed, Cox regressions were used to evaluate aseptic revision risk of the index knee using the no history groups as the reference in regression models. RESULTS: No difference in aseptic revision risk for the index knee was observed when comparing patients who had a prior primary arthroplasty in a different joint to those who did not have an arthroplasty history (hazard ratio = 0.95, 95% CI = 0.86-1.06). Those patients who did not have any prior aseptic revision history in a different joint had higher risk of aseptic revision in the index knee (hazard ratio = 2.06, 95% CI = 1.17-3.63). CONCLUSION: Patients who had a prior revision history had over a 2-fold higher risk of aseptic revision in the index knee, warranting close surveillance of these patients. LEVEL OF EVIDENCE: Level III.

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.

Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design setting and participants: We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures: Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results: Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions: We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

Temporal Trends in Deep Surgical Site Infections After Six Orthopaedic Procedures Over a 12-year Period Within a US-based Healthcare System.

INTRODUCTION: Centers of excellence and bundled payment models have driven perioperative optimization and surgical site infection (SSI) prevention with decolonization protocols and antibiotic prophylaxis strategies. We sought to evaluate time trends in the incidence of deep SSI and its causative organisms after six orthopaedic procedures in a US-based integrated healthcare system. METHODS: We conducted a population-level time-trend study using data from Kaiser Permanente's orthopaedic registries. All patients who underwent primary anterior cruciate ligament reconstruction (ACLR), total knee arthroplasty (TKA), elective total hip arthroplasty (THA), hip fracture repair, shoulder arthroplasty, and spine surgery were identified (2009 to 2020). The annual incidence of 90-day deep SSI was identified according to the National Healthcare Safety Network/Centers for Disease Control and Prevention guidelines with manual chart validation for identified infections. Poisson regression was used to evaluate annual trends in SSI incidence with surgical year as the exposure of interest. Annual trends in overall incidence and organism-specific incidence were considered. RESULTS: The final study sample was composed of 465,797 primary orthopaedic procedures. Over the 12-year study period, a decreasing trend in deep SSI was observed for ACLR and hip fracture repair. Although there was variation in incidence rates for specific operative years for TKA, elective THA, shoulder arthroplasty, and spine surgery, no consistent decreasing trends over time were found. Decreasing rates of Staphylococcus aureus infections over time after hip fracture repair, shoulder arthroplasty, and spine surgery and decreasing trends in antibiotic resistance after elective THA and spine surgery were also observed. Increasing trends of polymicrobial infections were observed after TKA and Cutibacterium acnes after elective THA. CONCLUSIONS: The overall incidence of deep SSI after six orthopaedic procedures was rare. Decreasing SSI rates were observed for ACLR and hip fracture repair within our US-based healthcare system. Polymicrobial infections after TKA and Cutibacterium acnes after elective THA warrant closer surveillance. LEVEL OF EVIDENCE: IV.

Association Between Race/Ethnicity and Total Joint Arthroplasty Utilization in a Universally Insured Population.

INTRODUCTION: Previous studies have documented racial and ethnic disparities in total joint arthroplasty (TJA) utilization in the United States. A potential mediator of healthcare disparities is unequal access to care, and studies have suggested that disparities may be ameliorated in systems of universal access. The purpose of this study was to assess whether racial/ethnic disparities in TJA utilization persist in a universally insured population of patients enrolled in a managed healthcare system. METHODS: This retrospective cohort study used data from a US integrated healthcare system (2015 to 2019). Patients aged 50 years and older with a diagnosis of hip or knee osteoarthritis were included. The outcome of interest was utilization of primary total hip arthroplasty and/or total knee arthroplasty, and the exposure of interest was race/ethnicity. Incidence rate ratios (IRRs) were modeled using multivariable Poisson regression controlling for confounders. RESULTS: There were 99,548 patients in the hip analysis and 290,324 in the knee analysis. Overall, 10.2% of the patients were Black, 20.5% were Hispanic, 9.6% were Asian, and 59.7% were White. In the multivariable analysis, utilization of primary total hip arthroplasty was significantly lower for all minority groups including Black (IRR, 0.55, 95% confidence interval [CI], 0.52-0.57, P < 0.0001), Hispanic (IRR, 0.63, 95% CI, 0.60-0.66, P < 0.0001), and Asian (IRR, 0.64, 95% CI, 0.61-0.68, P < 0.0001). Similarly, utilization of primary total knee arthroplasty was significantly lower for all minority groups including Black (IRR, 0.52, 95% CI, 0.49-0.54, P < 0.0001), Hispanic (IRR, 0.72, 95% CI, 0.70-0.75, P < 0.0001), and Asian (IRR, 0.60, 95% CI, 0.57-0.63, P < 0.0001) (all in comparison with White as reference). CONCLUSIONS: In this study of TJA utilization in a universally insured population of patients enrolled in a managed healthcare system, disparities on the basis of race and ethnicity persisted. Additional research is required to determine the reasons for this finding and to identify interventions which could ameliorate these disparities.

Do Dual-mobility Cups Reduce Revision Risk in Femoral Neck Fractures Compared With Conventional THA Designs? An International Meta-analysis of Arthroplasty Registries.

BACKGROUND: Dual-mobility cups in THA were designed to reduce prosthesis instability and the subsequent risk of revision surgery in high-risk patients, such as those with hip fractures. However, there are limited data from clinical studies reporting a revision benefit of dual-mobility over conventional THA. Collaboration between anthroplasty registries provides an opportunity to describe international practice variation and compare between-country, all-cause revision rates for dual-mobility and conventional THA. QUESTIONS/PURPOSES: We summarized observational data from multiple arthroplasty registries for patients receiving either a dual-mobility or conventional THA to ask: (1) Is dual-mobility use associated with a difference in risk of all-cause revision surgery compared with conventional THA? (2) Are there specific patient characteristics associated with dual-mobility use in the hip fracture population? (3) Has the use of dual-mobility constructs changed over time in patients receiving a THA for hip fracture? METHODS: Six member registries of the International Society of Arthroplasty Registries (from Australia, Denmark, Sweden, the Netherlands, the United Kingdom, and the United States) provided custom aggregate data reports stratified by acetabular cup type (dual-mobility or conventional THA) in primary THA for hip fracture between January 1, 2002, and December 31, 2019; surgical approach; and patient demographic data (sex, mean age, American Society of Anesthesiologists class, and BMI). The cumulative percent revision and mortality were calculated for each registry. To determine a global hazard ratio of all-cause revision for dual-mobility compared with conventional THA designs, we used a pseudoindividual patient data approach to pool Kaplan-Meier prosthesis revision data from each registry and perform a meta-analysis. The pseudoindividual patient data approach is a validated technique for meta-analysis of aggregate time-to-event survival data, such as revision surgery, from multiple sources. Data were available for 15,024 dual-mobility THAs and 97,200 conventional THAs performed for hip fractures during the study period. RESULTS: After pooling of complete Kaplan-Meier survival data from all six registries, the cumulative percent revision for conventional THA was 4.3% (95% confidence interval [CI] 4.2% to 4.5%) and 4.7% (95% CI 4.3% to 5.3%) for dual-mobility THA at 5 years. We did not demonstrate a lower risk of all-cause revision for patients receiving dual-mobility over conventional THA designs for hip fracture in the meta-analysis once between-registry differences were adjusted for (HR 0.96 [95% CI 0.86 to 1.06]). A lower proportion of dual-mobility procedures were revised for dislocation than conventional THAs (0.9% versus 1.4%) but a higher proportion were revised for infection (1.2% versus 0.8%). In most registries, a greater proportion of dual-mobility THA patients were older, had more comorbidities, and underwent a posterior approach compared with conventional THA (p < 0.001). The proportion of dual-mobility THA used to treat hip fractures increased in each registry over time and constituted 21% (2438 of 11,874) of all THA procedures in 2019. CONCLUSION: The proportion of dual-mobility THAs in patients with hip fractures increased over time, but there was large variation in use across countries represented here. Dual-mobility cups were not associated with a reduction in the overall risk of revision surgery in patients with hip fractures. A randomized controlled trial powered to detect the incidence of dislocation and subsequent revision surgery is required to clarify the efficacy of dual-mobility cups to treat hip fractures. LEVEL OF EVIDENCE: Level III, therapeutic study.

Risk of Revision After Hip Fracture Fixation Using DePuy Synthes Trochanteric Fixation Nail or Trochanteric Fixation Nail Advanced: A Cohort Study of 7,979 Patients.

BACKGROUND: Prior reports of the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) revealed a potential mode of fatigue failure at the proximal screw aperture following fixation of extracapsular hip fractures. We sought to compare the revision risk between the TFNA and its prior-generation forebear, the Trochanteric Fixation Nail (TFN). METHODS: A retrospective cohort study was performed using data from a U.S. integrated health-care system's hip fracture registry. The study sample comprised patients who underwent cephalomedullary nail fixation for hip fracture with a TFN (n = 4,007) or TFNA (n = 3,972) from 2014 to 2019. We evaluated the charts and radiographs for patients who underwent any revision. Multivariable Cox regression was used to evaluate the risk of revision related to the index fracture. RESULTS: At the 3-year follow-up, the cumulative probability of revision related to the index fracture was 1.8% for the TFN and 1.9% for the TFNA. After adjustment for covariates, no difference was observed in revision risk (hazard ratio [HR], 1.18 [95% confidence interval (CI), 0.80 to 1.75]; p = 0.40) for the TFNA compared with the TFN. The TFNA was associated with a higher risk of revision for nonunion than the TFN (HR, 1.86 [95% CI, 1.11 to 3.12]; p = 0.018). At the 3-year follow-up, implant breakage was 0.06% for the TFN and 0.2% for the TFNA; with regard to aperture failures related to the index fracture, there were 1 failure for the TFN group and 3 failures for the TFNA group. CONCLUSIONS: In a large cohort from a U.S. hip fracture registry, the TFNA had an overall revision rate that was similar to that of the earlier TFN, with implant breakage being a rare revision reason for both groups. Chart and radiographic review found that the TFNA was associated with a higher risk of revision for nonunion. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The effect of patient and prosthesis factors on revision rates after total knee replacement using a multi-registry meta-analytic approach.

BACKGROUND AND PURPOSE: Characteristics of patients receiving total knee arthroplasty (TKA) and prostheses used vary between regions and change with time. How these practice variations influence revision remains unclear. We combined registry data for better understanding of the impact of variation, which could potentially improve revision rates. PATIENTS AND METHODS: We used data from 2003 to 2019 for primary TKA from arthroplasty registries of Sweden (SKAR), Australia (AOANJRR), and Kaiser Permanente (KPJRR). We included 1,072,924 TKA procedures for osteoarthritis. Factors studied included age, sex, ASA class, BMI category, prosthesis constraint, fixation, bearing mobility, patellar resurfacing, and polyethylene type. Cumulative percentage revision (CPR) was calculated using Kaplan-Meier estimates, and unadjusted Cox hazard ratios were used for comparisons. Random-effects generic inverse-variance meta-analytic methods were used to determine summary effects. RESULTS: We found similarities in age and sex, but between-registry differences occurred in the other 7 factors studied. Patients from Sweden had lower BMI and ASA scores compared with other registries. Use of cement fixation was similar in the SKAR and KPJRR, but there were marked differences in patellar resurfacing and posterior stabilized component use. Meta-analysis results regarding survivorship favored patients aged ≥ 65 years and minimally stabilized components. There were inconsistent results with time for sex, fixation, and bearing mobility, and no differences for the patellar resurfacing or polyethylene type comparisons. INTERPRETATION: Marked practice variation was found. Use of minimally stabilized and possibly also cemented and fixed bearing prostheses is supported.