Comparison of Clinical Outcomes of Gripping Surface Technology Staple Reloads versus Standard Staple Reloads Used with Manual Linear Surgical Staplers.

Purpose: Linear surgical staplers reduce rates of surgical adverse events (bleeding, leaks, infections) compared to manual sutures thereby reducing patient risks, surgeon workflow disruption, and healthcare costs. However, further improvements are needed. Ethicon Gripping Surface Technology (GST) reloads, tested and approved by regulatory authorities in combination with powered staplers, may reduce surgical risks through improved tissue grip. While manual staplers are used in some regions due to affordability, clinical data on GST reloads used with manual staplers are unavailable. This study compared surgical adverse event rates of manual staplers with GST vs standard reloads. These data may be used for label changes in China and Latin America. Patients and Methods: Patients undergoing general or thoracic surgery between October 1, 2015 and August 31, 2021 using ECHELON FLEX™ manual staplers with GST or standard reloads were identified from the Premier Healthcare Database. GST reloads were compared to standard reloads for non-inferiority in bleeding and anastomotic leak for general surgery. Secondary outcomes included sepsis for general surgery, and bleeding and prolonged air leak for thoracic surgery. Covariate balancing was performed using stable balancing weights. Results: The general and thoracic surgery cohorts contained 4571 (GST: 2780; standard: 1791) and 814 (GST: 514; standard: 300) patients, respectively. GST reloads were non-inferior to standard reloads for bleeding and anastomotic leak (adjusted cumulative incidence ratio: 1.02 [90% CI: 0.71, 1.45] and 1.03 [90% CI: 0.72, 1.46], respectively) for general surgery. Compared with standard reloads, GST reloads had a similar incidence of sepsis (2.2% vs 2.1%) for general surgery and lower incidences of bleeding (9.5% vs 16.0%) and prolonged air leak (12.6% vs 14.0%,) for thoracic surgery. Conclusion: GST reloads, compared to standard reloads, used with ECHELON FLEX™ manual staplers had comparable perioperative bleeding and anastomotic leak for general surgery, and lower incidences of safety events for thoracic surgery.

Comparative Safety of the TFN-ADVANCED Proximal Femoral Nailing System: Findings from a U.S. Health-Care Database.

BACKGROUND: Proximal femoral fractures are often treated with cephalomedullary nails. Although nail breakages following fracture repair are infrequent, a recent implant retrieval study suggested that the TFN-ADVANCED (TFNA) Proximal Femoral Nailing System (DePuy Synthes) was susceptible to post-implant breakage. It is unclear whether the risk of breakage among patients who receive the TFNA implant is higher than patients who receive other comparable cephalomedullary nails. The current study was designed to evaluate the comparative risk of breakage of the TFNA nail. METHODS: Using data from a large U.S. health-care database, the current study was designed to determine whether TFNA nails have equal, lower, or higher risk of breakage relative to all other comparable, single-head-element (with no additional lag screws), cephalomedullary nails, the Stryker Gamma3 and the Zimmer Natural Nail, referred to in this study as the non-TFNA group. Data were from patients who received the TFNA implant or non-TFNA nails in 365 hospitals between February 1, 2014, and September 30, 2019. Analysis of nail breakage post-implantation was prespecified as the difference between the TFNA group and the non-TFNA group in cumulative incidence at 18 months, with a prespecified equivalence margin of 0.5%, using data balanced on measured covariates by propensity score weighting. RESULTS: Within the first 18 months of implantation, in 14,370 patients with TFNA nails, there were 27 nail breakages, and in 8,260 patients with non-TFNA nails, there were 29 nail breakages. The mean time to nail breakage was 4.72 months for the TFNA group and 4.05 months for the non-TFNA group. In the balanced data, the risk of breakage at 18 months was 0.26% (95% confidence interval [CI], 0.17% to 0.36%) for the TFNA group and 0.25% (95% CI, 0.05% to 0.45%) for the non-TFNA group, with a risk difference of 0.01% (95% CI, -0.21% to 0.24%). This result indicates that the cumulative incidence of nail breakage was equivalent (between -0.5% and 0.5%) for both nail groups. The risk differences were also within the equivalence margin in subgroup analyses: pertrochanteric fractures only (-0.08% [95% CI, -0.34% to 0.19%]), pertrochanteric or subtrochanteric fractures (-0.04% [95% CI, -0.29% to 0.21%]), and those with International Classification of Diseases, Tenth Revision (ICD-10) data only (0.03% [95% CI, -0.18% to 0.25%]). CONCLUSIONS: The risk of nail breakage was equivalent for TFNA and comparator cephalomedullary nails. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Variance estimation when using propensity-score matching with replacement with survival or time-to-event outcomes.

Propensity-score matching is a popular analytic method to estimate the effects of treatments when using observational data. Matching on the propensity score typically requires a pool of potential controls that is larger than the number of treated or exposed subjects. The most common approach to matching on the propensity score is matching without replacement, in which each control subject is matched to at most one treated subject. Failure to find a matched control for each treated subject can lead to "bias due to incomplete matching." To avoid this bias, it is important to identify a matched control subject for each treated subject. An alternative to matching without replacement is matching with replacement, in which control subjects are allowed to be matched to multiple treated subjects. A limitation to the use of matching with replacement is that variance estimation must account for both the matched nature of the sample and for some control subjects being included in multiple matched sets. While a variance estimator has been proposed for when outcomes are continuous, no such estimator has been proposed for use with time-to-event outcomes, which are common in medical and epidemiological research. We propose a variance estimator for the hazard ratio when matching with replacement. We conducted a series of Monte Carlo simulations to examine the performance of this estimator. We illustrate the utility of matching with replacement to estimate the effect of smoking cessation counseling on survival in smokers discharged from hospital with a heart attack.

Postmarket surveillance of arthroplasty device components using machine learning methods.

PURPOSE: While joint arthroplasty is generally a safe and effective procedure, there are concerns that some devices are at increased risk of failure. Early identification of total hip arthroplasty devices with increased risk of failure can be challenging because devices consist of multiple components, hundreds of distinct components are currently used in surgery, and any estimated effect needs to address confounding due to device and patient factors. The purpose of this study was to assess the effectiveness of machine learning approaches at identifying recalled components listed by the US Food and Drug Administration using data from a US total joint arthroplasty registry. METHODS: An open cohort study was conducted using data (January 1, 2001, to December 31, 2015) from 74 520 implantations and 348 unique components in the Kaiser Permanente Total Joint Replacement Registry. Exposures of interest were device components used in elective primary total hip arthroplasty. The outcome was time to first revision surgery, defined as exchange, removal, or addition of any component. Machine learning methods included regularized/unregularized Cox models and random survival forest. RESULTS: Among the recalled components detected were ASR acetabular shell/large femoral head, Durom acetabular shell/Metasul large femoral head, and Rejuvenate modular neck stem. The three components not identified were characterized by small numbers of devices recorded in the registry. CONCLUSIONS: The novel approaches to signal detection may improve postmarket surveillance of frequently used arthroplasty devices, which in turn will improve public health.

An international comparison of THA patients, implants, techniques, and survivorship in Sweden, Australia, and the United States.

Background and purpose - International comparisons of total hip arthroplasty (THA) practices and outcomes provide an opportunity to enhance the quality of care worldwide. We compared THA patients, implants, techniques, and survivorship in Sweden, Australia, and the United States. Patients and methods - Primary THAs due to osteoarthritis were identified using Swedish (n = 159,695), Australian (n = 279,693), and US registries (n = 69,641) (2003-2015). We compared patients, practices, and implant usage across the countries using descriptive statistics. We evaluated time to all-cause revision using Kaplan-Meier survival curves. We assessed differences in countries' THA survival using chi-square tests of survival probabilities. Results - Sweden had fewer comorbidities than the United States and Australia. Cement fixation was used predominantly in Sweden and cementless in the United States and Australia. The direct anterior approach was used more frequently in the United States and Australia. Smaller head sizes (≤ 32 mm vs. ≥ 36 mm) were used more often in Sweden than the United States and Australia. Metal-on-highly cross-linked polyethylene was used more frequently in the United States and Australia than in Sweden. Sweden's 5- (97.8%) and 10-year THA survival (95.8%) was higher than the United States' (5-year: 97.0%; 10-year: 95.2%) and Australia (5-year: 96.3%; 10-year: 93.5%). Interpretation - Patient characteristics, surgical techniques, and implants differed across the 3 countries, emphasizing the need to adjust for demographics, surgical techniques, and implants and the need for global standardized definitions to compare THA survivorship internationally.

Survival and Reintervention Risk by Patient Age and Preoperative Abdominal Aortic Aneurysm Diameter after Endovascular Aneurysm Repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) has become the standard of care for abdominal aortic aneurysm (AAA), but questions remain regarding the benefit in high-risk and elderly patients. The purpose of this study was to examine the effect of age, preoperative AAA diameter, and their interaction on survival and reintervention rates after EVAR. METHODS: Our integrated health system's AAA endograft registry was used to identify patients who underwent elective EVAR between 2010 and 2014. Of interest was the effect of patient age at the time of surgery (≤80 vs. >80 years old), preoperative AAA diameter (≤5.5 cm vs. >5.5 cm), and their interaction. Primary endpoints were all-cause mortality and reintervention. Between-within mixed-effects Cox models with propensity score weights were fit. RESULTS: Of 1,967 patients undergoing EVAR, unadjusted rates for survival at 4 years after EVAR was 76.1%, and reintervention-free rate was 86.0%. For mortality, there was insufficient evidence for an interaction between age and AAA size (P = 0.309). Patient age >80 years was associated with 2.53-fold higher mortality risk (hazard ratios [HR] = 2.53; 95% confidence intervals [CI], 1.73-3.70; P < 0.001), whereas AAA > 5.5 cm was associated with 1.75-fold higher mortality risk (HR = 1.75; 95% CI, 1.26-2.45; P = 0.001). For reintervention risk, there were no significant interactions or main effects for age or AAA diameter. CONCLUSIONS: Age and AAA diameter are independent predictors of reduced survival after EVAR, but the effect is not amplified when both are present. Age >80 years or AAA size >5.5 cm did not increase the risk of reintervention. No specific AAA size, patient age, or combination thereof was identified that would contraindicate AAA repair.

Midterm-Adjusted Survival Comparing the Best Performing Unicompartmental and Total Knee Arthroplasties in a Registry.

BACKGROUND: Recent literature suggests that the difference in revision risk between unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) can be influenced by surgeon volume and other confounders. We hypothesized that implant selection might decrease the relative risk of revision in an adjusted model. METHODS: We selected the best performing (BP) primary UKAs and TKAs performed for osteoarthritis between January 2001 and December 2012 collected through a joint replacement registry. We compared aseptic and all-cause risk of revision using a surgeon-stratified Cox regression model with propensity score adjustment. RESULTS: One thousand fifty-four UKAs were compared with 74,185 TKAs. The rate for all-cause revision was lower for UKAs (2.1%) than for TKAs (2.4%), whereas the rate for aseptic revision was higher for UKAs (2.0%) than TKAs (1.4%). The adjusted risk of aseptic revision was not significantly higher for UKA than TKA (hazard ratio = 2.02 [0.68, 5.96], P = .203) or all-cause revision (hazard ratio = 1.24 [0.52, 2.98], P = .603). CONCLUSION: When comparing the survivorship of the BP UKAs to the BP TKAs in our registry, the adjusted risk of revision remained higher for UKAs than for TKAs, although the difference did not reach statistical significance.

Is There a Difference in Revision Risk Between Metal and Ceramic Heads on Highly Crosslinked Polyethylene Liners?

BACKGROUND: The most common bearing surface used among primary THAs worldwide is a metal or ceramic femoral head that articulates against a highly crosslinked ultrahigh-molecular-weight polyethylene (HXLPE) acetabular liner. Despite their widespread use, relatively little is known about the comparative effectiveness of ceramic versus metal femoral heads with respect to risk of revision and dislocation as well as the role of head size in this relationship. QUESTIONS/PURPOSES: The purpose of this study was to evaluate the risk of (1) all-cause revision in metal versus ceramic femoral heads when used with an HXLPE liner, including an evaluation of the effect of head size; and (2) dislocation in metal versus ceramic femoral heads when used with an HXLPE liner as well as an assessment of the effect of head size. METHODS: Data were collected as part of the Kaiser Permanente Total Joint Replacement Registry between 2001 and 2013. Patients in this study were on average overweight (body mass index = 29 kg/m2), 67 years old, mostly female (57%), and had osteoarthritis (93%) as the primary indication for surgery. The material of the femoral head (metal, ceramic) was crossed with head size (< 32, 32, 36, > 36 mm), yielding eight device groupings. Only uncemented devices were evaluated. The primary outcome was all-cause revision (n = 28,772) and the secondary outcome was dislocation within 1 year (n = 19,623). Propensity scores were used to adjust for potential confounding at the implant/patient level using between-within semiparametric survival models that control for surgeon and hospital confounding and adjust estimates for the within-cluster correlation among observations on the response. RESULTS: For all-cause revision, there was no difference between ceramic versus metal (reference) heads in combination with an HXLPE liner (hazard ratio [HR] = 0.82 [0.65-1.04], p = 0.099). Smaller metal head sizes of < 32 mm were associated with increased risk of revision relative to 36 mm (HR = 1.66 [1.20-2.31], p = 0.002, adjusted p = 0.025). For dislocation, ceramic heads increased risk relative to metal at < 32 mm only (HR = 4.39 [1.72-11.19], p = 0.002, adjusted p = 0.020). Head sizes < 32 mm were associated with increased risk of dislocation relative to 36 mm for metal (HR = 2.99 [1.40-6.39], p = 0.005, adjusted p = 0.047) and ceramic heads (HR = 15.69 [6.07-40.55], p < 0.001, adjusted p < 0.001). CONCLUSIONS: The results did not provide evidence for use of one femoral head material over another when used with HXLPE liners for the outcome of revision, but for dislocation, metal performed better than ceramic with < 32-mm heads. Overall, the findings suggest increased risk of revision/dislocation with head sizes < 32 mm. LEVEL OF EVIDENCE: Level III, therapeutic study.

Type and frequency of healthcare encounters can predict poor surgical outcomes in anterior cruciate ligament reconstruction patients.

BACKGROUND: Several challenges are associated with collecting clinically meaningful post-operative outcomes. The widespread implementation of electronic medical records (EMR) offers a new opportunity to evaluate surgical outcomes using routinely collected data in these systems. This study evaluated whether surgical outcomes can be ascertained from EMR's hospital and outpatient encounters. Specifically, we evaluated anterior cruciate ligament reconstructions (ACLR) outcomes. METHODS: A retrospective cohort study of 6985 ACLRs performed between 2/2005-9/2012 was conducted. Patient encounters during days 1-90 and days 91-180 after ACLR surgery were the exposures of interest. Nine hospital and eight outpatient encounter types were evaluated. The main endpoint of the study was revision surgery six months after ACLR. RESULTS: The cohort was 66.7% male, the mean age was 28 (standard deviation=11) years-old, and the incidence of revision was 1.5% (n=105). After adjustments, in days 1-90 post-ACLR, compared to patients with 0-4 orthopedic office visits, patients with 5-9 (hazard ratio (HR)=9.9, 95% confidence interval(CI), 4.3-23.2) and those with 10 or more (HR=13.8, 95%CI, 5.6-33.8) visits had a higher risk of revision. In days 91-180, patients with any outpatient hospital encounters (HR=2.5, 95%CI 1.4-4.5) had a higher risk of revision than patients without visits. Additionally, patients with 4-5 regular office visits (HR=3.8 times, 95%CI, 2.0-7.0) had a higher risk of revision surgery than those with 0-1 visits. DISCUSSION: The number of post-operative outpatient visits was associated with ACLR revision surgery. Using EMR encounters to assess surgical outcomes is a viable option for monitoring ACLR patients. The simple assessment of visit types and number of encounters alone can provide valuable information regarding the normal course of rehabilitation of a surgical patient and possible deviation from this normal course. In large cohorts of patients, this type of patient surveillance can assist surgeons with monitoring their patients.

Similar mortality with general or regional anesthesia in elderly hip fracture patients.

BACKGROUND AND PURPOSE: There is continuing confusion among practitioners with regard to the optimal choice of anesthetic type for repair of hip fractures. We investigated whether type of anesthetic was associated with short-term mortality after hip fracture surgery. PATIENTS AND METHODS: We conducted a retrospective cohort study of patients with surgically treated hip fractures, performed between January 1, 2009 and December 31, 2012. Exposure of interest was anesthesia type (general, spinal/neuroaxial, and mixed). Endpoints were 30-, 90-, and 365-day post-surgery mortality. Multivariable conditional logistic regression models were used and odds ratios (ORs) and 95% confidence intervals (CIs) are reported. RESULTS: Of the 7,585 participants, 5,412 (71%) were women and the median age was 80 (IQR: 72-85) years old. Of the total cohort, 4,257 (56%) received general anesthesia, 3,059 (40%) received spinal/neuroaxial, and 269 (4%) received mixed anesthesia. Overall, the incidence of 30-, 90-, and 365-day mortality was 4% (n = 307), 8% (n = 583), and 15% (n = 1,126), respectively. When compared with general anesthesia, the 365-day odds of mortality was marginally lower in patients with spinal/neuroaxial anesthesia (OR = 0.84, CI: 0.70-1.0), but it was similar in patients with mixed anesthesia (OR = 1.3, CI: 0.70-2.3). No other statistically significant differences were observed. INTERPRETATION: Regarding mortality, this study does not support specific recommendations regarding the type of anesthetic in surgery of fractured hips.

Revision total hip arthoplasty: factors associated with re-revision surgery.

BACKGROUND: The survivorship of implants after revision total hip arthroplasty and risk factors associated with re-revision are not well defined. We evaluated the re-revision rate with use of the institutional total joint replacement registry. The purpose of this study was to determine patient, implant, and surgeon factors associated with re-revision total hip arthroplasty. METHODS: A retrospective cohort study was conducted. The total joint replacement registry was used to identify patients who had undergone revision total hip arthroplasty for aseptic reasons from April 1, 2001, to December 31, 2010. The end point of interest was re-revision total hip arthroplasty. Risk factors evaluated for re-revision total hip arthroplasty included: patient risk factors (age, sex, body mass index, race, and general health status), implant risk factors (fixation type, bearing surface, femoral head size, and component replacement), and surgeon risk factors (volume and experience). A multivariable Cox proportional hazards model was used. RESULTS: Six hundred and twenty-nine revision total hip arthroplasties with sixty-three (10%) re-revisions were evaluated. The mean cohort age (and standard deviation) was 57.0 ± 12.4 years, the mean body mass index (and standard deviation) was 29.5 ± 6.1 kg/m(2), and most of the patients were women (64.5%) and white (81.9%) and had an American Society of Anesthesiologists score of <3 (52.9%). The five-year implant survival after revision total hip arthroplasty was 86.8% (95% confidence interval, 83.57% to 90.25%). In adjusted models, age, total number of revision surgical procedures performed by the surgeon, fixation, and bearing surface were associated with the risk of re-revision. For every ten-year increase in patient age, the hazard ratio for re-revision decreases by a factor of 0.72 (95% confidence interval, 0.58 to 0.90). For every five revision surgical procedures performed by a surgeon, the risk of revision decreases by a factor of 0.93 (95% confidence interval, 0.86 to 0.99). At the time of revision, a new or retained cemented femoral implant or all-cemented hip implant increases the risk of revision by a factor of 3.19 (95% confidence interval, 1.22 to 8.38) relative to a retained or new uncemented hip implant. A ceramic on a highly cross-linked polyethylene bearing articulation decreases the hazard relative to metal on highly cross-linked polyethylene by a factor of 0.32 (95% confidence interval, 0.11 to 0.95). Metal on constrained bearing increases the hazard relative to metal on highly cross-linked polyethylene by a factor of 3.32 (95% confidence interval, 1.16 to 9.48). CONCLUSIONS: When evaluating patient, implant, and surgical factors at the time of revision total hip arthroplasty, age, surgeon experience, implant fixation, and bearing surfaces had significant impacts on the risk of re-revision.

Anterior and Anterolateral Approaches for THA Are Associated With Lower Dislocation Risk Without Higher Revision Risk.

BACKGROUND: Lack of consensus continues regarding the benefit of anteriorly based surgical approaches for primary total hip arthroplasty (THA). The purpose of this study was to evaluate the risk of aseptic revision, septic revision, and dislocations for various approaches used in primary THAs from a community-based healthcare organization. QUESTIONS/PURPOSES: (1) What is the incidence of aseptic revision, septic revision, and dislocation for primary THA in a large community-based healthcare organization? (2) Does the risk of aseptic revision, septic revision, and dislocation vary by THA surgical approach? METHODS: The Kaiser Permanente Total Joint Replacement Registry was used to identify primary THAs performed between April 1, 2001 and December 31, 2011. Endpoints were septic revisions, aseptic revisions, and dislocations. The exposure of interest was surgical approach (posterior, anterolateral, direct lateral, direct anterior). Patient, implant, surgeon, and hospital factors were evaluated as possible confounders. Survival analysis was performed with marginal multivariate Cox models. Hazard ratios (HRs) and 95% confidence intervals (CIs) are reported. A total of 42,438 primary THAs were available for analysis of revision outcomes and 22,237 for dislocation. Median followup was 3 years (interquartile range, 1-5 years). The registry's voluntary participation is 95%. The most commonly used approach was posterior (75%, N = 31,747) followed by anterolateral (10%, N = 4226), direct anterior (4%, N = 1851), and direct lateral (2%, N = 667). RESULTS: During the study period 785 hips (2%) were revised for aseptic reasons, 213 (0.5%) for septic reasons, and 276 (1%) experienced a dislocation. The revision rate per 100 years of observation was 0.54 for aseptic revisions, 0.15 for septic revisions, and 0.58 for dislocations. There were no differences in adjusted risk of revision (either septic or aseptic) across the different THA approaches. However, the anterolateral approach (adjusted HR, 0.29; 95% CI, 0.13-0.63, p = 0.002) and direct anterior approach (adjusted HR, 0.44; 95% CI, 0.22-0.87, p = 0.017) had a lower risk of dislocation relative to the posterior approach. There were no differences in any of the outcomes when comparing the direct anterior approach with the anterolateral approach. CONCLUSIONS: Anterior and anterolateral surgical approaches had the advantage of a lower risk of dislocation without increasing the risk of early revision. LEVEL OF EVIDENCE: Level III, therapeutic study.

Is there a difference in total knee arthroplasty risk of revision in highly crosslinked versus conventional polyethylene?

BACKGROUND: Highly crosslinked polyethylene (HXLPE) was introduced to reduce wear and associated osteolysis in total knee arthroplasty (TKA). However, there is limited clinical evidence that HXLPE is more effective than conventional polyethylene (CPE) in TKA. QUESTIONS/PURPOSES: (1) Do primary TKAs with HXLPE tibial inserts have a lower risk of revision (all-cause, aseptic, and septic) than TKAs with CPE tibial inserts? (2) In NexGen TKA (Zimmer Inc, Warsaw, IN, USA) bearings, do HXLPE tibial inserts have a lower risk of revision (all-cause, aseptic, and septic) than CPE tibial inserts? (3) In Press-Fit Condylar TKA (PFC or PFC Sigma; DePuy Inc, Warsaw, IN, USA), do HXLPE tibial inserts have a lower risk of revision (all-cause, aseptic, and septic) than procedures performed with CPE tibial inserts? METHODS: The Kaiser Permanente Total Joint Replacement Registry was used to identify primary TKAs (N = 77,084) performed during the study period (April 2001 to December 2011) with cobalt-chromium alloy on CPE (CoCr-CPE) and CoCr-HXLPE bearings. The registry has 95% voluntary participation and less than 9% were loss to followup during the 10-year study period. A total of 60,841 (79%) had CoCr-CPE bearings, 11,048 (14%) had CoCr-HXLPE bearings, and 5195 (7%) were unknown. Specific knee implant designs (NexGen, Zimmer and PFC-Sigma, DePuy Inc) were also evaluated. These implants represented 41% (31,793) and 49% (37,457), respectively, of the 77,084 TKAs of known implant types registered during that period; implant selection was at the discretion of the attending surgeon. Descriptive statistics and marginal Cox regression models with propensity score adjustments were applied to compare risk of revision for CoCr-CPE versus CoCr-HXLPE TKA bearings. RESULTS: At 5 years followup, cumulative incidence of revision for CoCr-CPE and CoCr-XLPE were 2.7% and 3.1%, respectively. Adjusted risks of all-cause (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.86-1.29; p = 0.620), aseptic (HR, 1.01; 95% CI, 0.77-1.32; p = 0.954), and septic revision (HR, 1.11; 95% CI, 0.81-1.51; p = 0.519) did not differ in patients with CoCr-XLPE bearings compared with CoCr-CPE. Within TKAs with NexGen components, the adjusted risks of all-cause (HR, 1.14; 95% CI, 0.86-1.51; p = 0.354), aseptic (HR, 1.14; 95% CI, 0.79-1.65; p = 0.493), and septic revision (HR, 1.14; 95% CI, 0.76-1.73; p = 518) were similar in patients with CoCr-XLPE compared with those with CoCr-CPE bearings. Finally, within the TKAs with PFC components, the adjusted risks of all-cause (HR, 0.80; 95% CI, 0.49-1.30; p = 0.369), aseptic (HR, 0.62; 95% CI, 0.62-1.14; p = 0.123), and septic revision (HR, 0.97; 95% CI, 0.51-1.85; p = 0.929) were also similar in patients with CoCr-XLPE compared with those with CoCr-CPE bearings. CONCLUSIONS: In this large study, we did not find differences in risk of revision for CoCr-HXLPE compared with CoCr-CPE bearings at 5 years followup. In selecting HXLPE in TKA, clinicians should consider the increased cost and lack of available evidence of performance for greater than 10 years followup. Future studies are necessary to evaluate longitudinal outcomes of CoCr-HXLPE versus conventional TKA bearings. LEVEL OF EVIDENCE: Level III, therapeutic study.

A distributed health data network analysis of survival outcomes: the International Consortium of Orthopaedic Registries perspective.

The International Consortium for Orthopaedic Registries is a multinational initiative established by the United States Food and Drug Administration to develop a health data network aimed at providing a robust infrastructure to facilitate evidence-based decision-making on performance of medical devices. Through the International Consortium for Orthopaedic Registries, individual data holders have complete control of their data and can choose to participate in studies of their choice. In this article, we present an overview of the data extraction process and the analytic strategy employed to answer several device performance-related questions in total hip arthroplasty and total knee arthroplasty. In the process, we discuss some nuances pertinent to International Consortium for Orthopaedic Registries data that pose certain statistical challenges, and we briefly suggest strategies to be adopted to address them.

Effect of femoral head size on metal-on-HXLPE hip arthroplasty outcome in a combined analysis of six national and regional registries.

BACKGROUND: HXLPE (highly cross-linked polyethylene) has greater wear resistance compared with UHMWPE (ultra-high molecular weight polyethylene), which may contribute to improving the outcomes of total hip arthroplasty with a large femoral head. However, no information is available regarding the effect of femoral head size on the survivorship of HXLPE hip prostheses. The aim of the present study was to provide evidence regarding whether femoral head size has an effect on the risk of revision when an HXLPE liner is used on a metal head. METHODS: A distributed health data network was developed by the ICOR (International Consortium of Orthopaedic Registries). Six national and regional registries are participating in this network: Kaiser Permanente, HealthEast, the Emilia-Romagna region in Italy, the Catalan region in Spain, Norway, and Australia. Data from each registry were standardized and provided at an aggregate level for each of the variables of interest. Patients with osteoarthritis who were forty-five to sixty-four years of age and had undergone uncemented total hip arthroplasty were included in the present study. Analyses were performed on the basis of individual patient profiles, utilizing the variables collected from each registry. The outcome of interest was the time to the first revision (for any reason). Survival probabilities and their standard errors were extracted from each registry for each unique combination of the covariates and were combined through multivariate meta-analysis utilizing linear mixed models to compare survivorship for <32-mm, 32-mm, and >32-mm femoral head sizes. RESULTS: A total of 14,372 total hip arthroplasties were included in the study. The five-year rate of revision surgery varied from 1.9% to 3.2% among registries. The risk of revision did not differ significantly between <32-mm and 32-mm head sizes (HR [hazard ratio] = 0.91, 95% CI [confidence interval] = 0.69 to 1.19) or between >32-mm and 32-mm sizes (HR = 1.05, 95% CI = 0.70 to 1.55). CONCLUSIONS: The results of our study provide relevant data to orthopaedic surgeons deciding on the use of a larger articulation in a metal-on-polyethylene bearing. A larger head diameter should not be considered a detriment to device survival when an HXLPE liner is used. However, efforts to force the use of a large-size implant appear unsupported, as similar survivorship was observed for all head diameter groups.

Risk of revision following total hip arthroplasty: metal-on-conventional polyethylene compared with metal-on-highly cross-linked polyethylene bearing surfaces: international results from six registries.

The results of randomized controlled trials and systematic reviews have suggested reduced radiographic wear in highly cross-linked polyethylene compared with conventional polyethylene in primary total hip arthroplasty. However, longer-term clinical results have not been thoroughly examined, to our knowledge. The purpose of this study was to compare the risk of revision for metal-on-conventional and metal-on-highly cross-linked total hip arthroplasty bearing surfaces with use of a distributed data network of six national and regional registries (Kaiser Permanente, HealthEast, the Emilia-Romagna region in Italy, the Catalan region in Spain, Norway, and Australia). Inclusion criteria were osteoarthritis as the primary diagnosis, cementless implant fixation, and a patient age of forty-five to sixty-four years. These criteria resulted in a sample of 16,571 primary total hip arthroplasties. Multivariate meta-analysis was performed with use of linear mixed models, with survival probability as the unit of analysis. The results of a fixed-effects model suggested that there was insufficient evidence of a difference in risk of revision between bearing surfaces (hazard ratio, 1.20 [95% confidence interval, 0.80 to 1.79]; p = 0.384). Highly cross-linked polyethylene does not appear to have a reduced risk of revision in this subgroup of total hip arthroplasty patients. Arthroplasties involving highly cross-linked polyethylene do not appear to have an increased risk of revision in this subgroup of total hip arthroplasty patients.

Distributed analysis of hip implants using six national and regional registries: comparing metal-on-metal with metal-on-highly cross-linked polyethylene bearings in cementless total hip arthroplasty in young patients.

BACKGROUND: The regulation of medical devices has attracted controversy recently because of problems related to metal-on-metal hip implants. There is growing evidence that metal-on-metal implants fail early and cause local and systemic complications. However, the failure associated with metal-on-metal head size is not consistently documented and needs to be communicated to patients and surgeons. The purpose of this study is to compare implant survival of metal on metal with that of metal on highly cross-linked polyethylene. METHODS: Using a distributed health data network, primary total hip arthroplasties were identified from six national and regional total joint arthroplasty registries (2001 to 2010). Inclusion criteria were patient age of forty-five to sixty-four years, cementless total hip arthroplasties, primary osteoarthritis diagnosis, and exclusion of the well-known outlier implant ASR (articular surface replacement). The primary outcome was revision for any reason. A meta-analysis of survival probabilities was performed with use of a fixed-effects model. Metal-on-metal implants with a large head size of >36 mm were compared with metal-on-highly cross-linked polyethylene implants. RESULTS: Metal-on-metal implants with a large head size of >36 mm were used in 5172 hips and metal-on-highly cross-linked polyethylene implants were used in 14,372 hips. Metal-on-metal total hip replacements with a large head size of >36 mm had an increased risk of revision compared with metal-on-highly cross-linked polyethylene total hip replacements with more than two years of follow-up, with no difference during the first two years after implantation. The results of the hazard ratios (and 95% confidence intervals) from the multivariable model at various durations of follow-up were 0.95 (0.74 to 1.23) at zero to two years (p = 0.698), 1.42 (1.16 to 1.75) at more than two years to four years (p = 0.001), 1.78 (1.45 to 2.19) at more than four years to six years (p < 0.001), and 2.15 (1.63 to 2.83) at more than six years to seven years (p < 0.001). CONCLUSIONS: We conducted a comparison of large-head-size, metal-on-metal implants and metal-on-highly cross-linked polyethylene implants in younger patients with uncemented fixation. We found consistent and strong evidence worldwide that large-head-size, metal-on-metal implants were associated with increased risk of revision after two years compared with metal-on-highly cross-linked polyethylene implants, with the effect becoming more pronounced over time.

Comparative effectiveness of ceramic-on-ceramic implants in stemmed hip replacement: a multinational study of six national and regional registries.

BACKGROUND: The rapid decline in use of conventional total hip replacement with a large femoral head size and a metal-on-metal bearing surface might lead to increased popularity of ceramic-on-ceramic bearings as another hard-on-hard alternative that allows implantation of a larger head. We sought to address comparative effectiveness of ceramic-on-ceramic and metal-on-HXLPE (highly cross-linked polyethylene) implants by utilizing the distributed health data network of the ICOR (International Consortium of Orthopaedic Registries), an unprecedented collaboration of national and regional registries and the U.S. FDA (Food and Drug Administration). METHODS: A distributed health data network was developed by the ICOR and used in this study. The data from each registry are standardized and provided at a level of aggregation most suitable for the detailed analysis of interest. The data are combined across registries for comprehensive assessments. The ICOR coordinating center and study steering committee defined the inclusion criteria for this study as total hip arthroplasty performed without cement from 2001 to 2010 in patients forty-five to sixty-four years of age with osteoarthritis. Six national and regional registries (Kaiser Permanente and HealthEast in the U.S., Emilia-Romagna region in Italy, Catalan region in Spain, Norway, and Australia) participated in this study. Multivariate meta-analysis was performed with use of linear mixed models, with survival probability as the unit of analysis. We present the results of the fixed-effects model and include the results of the random-effects model in an appendix. SAS version 9.2 was used for all analyses. We first compared femoral head sizes of >28 mm and ≤28 mm within ceramic-on-ceramic implants and then compared ceramic-on-ceramic with metal-on-HXLPE. RESULTS: A total of 34,985 patients were included; 52% were female. We found a lower risk of revision associated with use of ceramic-on-ceramic implants when a larger head size was used (HR [hazard ratio] = 0.73, 95% CI [confidence interval] = 0.60 to 0.88, p = 0.001). Use of smaller-head-size ceramic-on-ceramic bearings was associated with a higher risk of failure compared with metal-on-HXLPE bearings (HR = 1.36, 95% CI = 1.09 to 1.68, p = 0.006). Use of large-head-size ceramic-on-ceramic bearings was associated with a small protective effect relative to metal-on-HXLPE bearings (not subdivided by head size) in years zero to two, but this difference dissipated over the longer term. CONCLUSIONS: Our multinational study based on a harmonized, distributed network showed that use of ceramic-on-ceramic implants with a smaller head size in total hip arthroplasty without cement was associated with a higher risk of revision compared with metal-on-HXLPE and >28-mm ceramic-on-ceramic implants. These findings warrant careful reflection by regulatory and clinical communities and wide dissemination to patients for informed decision-making regarding such surgery.

International comparative evaluation of knee replacement with fixed or mobile non-posterior-stabilized implants.

BACKGROUND: Mobile-bearing total knee prostheses were designed to reduce wear and improve implant survivorship following total knee arthroplasty. However, the benefit of mobile-bearing total knee arthroplasty remains unproven. Both mobile-bearing and fixed-bearing total knee arthroplasty implants are available in posterior-stabilized and non-posterior-stabilized designs. With the latter, the implant does not recreate the function of the posterior cruciate ligament (PCL) with a posterior-stabilizing cam mechanism. The purpose of the present study was to compare mobile-bearing, non-posterior-stabilized devices with fixed-bearing, non-posterior-stabilized devices used in total knee arthroplasty through a novel multinational study design. METHODS: Through the use of a distributed health data network, primary total knee arthroplasties performed for osteoarthritis from 2001 to 2010 were identified from six national and regional total joint arthroplasty registries. Multivariate meta-analysis was performed with use of linear mixed models, with the primary outcome of interest being revision for any reason. Survival probabilities and their standard errors were extracted from each registry for each unique combination of the covariates. RESULTS: A total of 319,616 patients (60% female) underwent non-posterior-stabilized total knee arthroplasty. A fixed-bearing, non-posterior-stabilized design was used in 258,190 (81%) of the knees and a mobile-bearing, non-posterior-stabilized design in 61,426 (19%) of the knees. Sixty-nine percent of the patients who received a fixed-bearing implant were over sixty-five years of age, compared with 63% of those who received a mobile-bearing implant. Mobile-bearing designs had a higher risk of revision, with a hazard ratio of 1.43 (95% confidence interval, 1.36 to 1.51; p < 0.001). CONCLUSIONS: Previous comparisons of mobile-bearing and fixed-bearing total knee arthroplasty outcomes have been inconclusive. The current study utilized an advanced, harmonized distributed analysis of six national and regional joint-replacement registries. To our knowledge, it is the largest analysis of mobile-bearing total knee arthroplasty to date. Mobile-bearing, non-posterior-stabilized designs presented a greater risk of failure than was found for fixed-bearing, non-posterior-stabilized designs. Caution should be used in the selection of the mobile-bearing non-posterior-stabilized design for total knee replacement.

International comparative evaluation of fixed-bearing non-posterior-stabilized and posterior-stabilized total knee replacements.

BACKGROUND: Differences in survivorship of non-posterior-stabilized compared with posterior-stabilized knee designs carry substantial economic consequences, especially with limited health-care resources. However, these comparisons have often been made between relatively small groups of patients, often with short-term follow-up, with only small differences demonstrated between the groups. The goal of this study is to compare the outcomes of non-posterior-stabilized and posterior-stabilized total knee arthroplasties with use of a unique collaboration of multiple established knee arthroplasty registries. METHODS: A distributed health data network was developed by the International Consortium of Orthopaedic Registries and was used in this study to reduce barriers to participation (such as security, propriety, legal, and privacy issues) compared with a centralized data warehouse approach. The study included only replacements in osteoarthritis patients who underwent total knee procedures involving fixed-bearing devices from 2001 to 2010. The outcome of interest was time to first revision. RESULTS: On average, not resurfacing showed a more harmful effect than resurfacing did when posterior-stabilized and non-posterior-stabilized knee replacements were compared, while the risk of revision for posterior-stabilized compared with non-posterior-stabilized knees was highest in year zero to one, followed by year one to two, years eight through ten, and years two through eight. Posterior-stabilized knees did significantly worse than non-posterior-stabilized knees did when the patella was not resurfaced. This difference was most pronounced in the first two years (year zero to one: hazard ratio [HR] = 2.15, 95% confidence interval [CI] = 1.56 to 2.95, p < 0.001; year one to two: HR = 1.61, 95% CI = 1.48 to 1.75, p < 0.001). When the patella was resurfaced, posterior-stabilized knees did significantly worse than non-posterior-stabilized knees did. This was again most pronounced in the first two years (year zero to one: HR = 1.75, 95% CI = 1.27 to 2.42, p = 0.001; year one to two: HR = 1.31, 95% CI = 1.19 to 1.45, p < 0.001). There was a reduced risk of revision with a patient age of more than sixty-five years (HR = 0.57, 95% CI = 0.55 to 0.60, p < 0.001). CONCLUSIONS: We found that fixed non-posterior-stabilized total knee arthroplasty performed better with or without patellar resurfacing than did fixed posterior-stabilized total knee arthroplasty. This effect was most pronounced in the first two years. The risk of revision for posterior-stabilized total knee arthroplasties was reduced with patellar resurfacing. Also, a patient age of more than sixty-five years and female gender reduced the risk of revision.