Proposal for a classification system of radiographic bone changes after cervical disc replacement.

BACKGROUND: The goal of this study is to propose a classification system with a common nomenclature for radiographic observations of periprosthetic bone changes following cTDR. METHODS: Aided by serial plain radiographs from recent cTDR cases (34 patients; 44 devices), a panel of experts assembled for the purpose of creating a classification system to aid in reproducibly and accurately identifying bony changes and assessing cTDR radiographic appearance. Subdividing the superior and inferior vertebral bodies into 3 equal sections, observed bone loss such as endplate rounding, cystic erosion adjacent to the endplate, and cystic erosion not adjacent to the endplate, is recorded. Determining if bone loss is progressive, based on serial radiographs, and estimating severity of bone loss (measured by the percentage of end plate involved) is recorded. Additional relevant bony changes and device observations include radiolucent lines, heterotopic ossification, vertebral body olisthesis, loss of core implant height, and presence of device migration, and subsidence. RESULTS: Serial radiographs from 19 patients (25 devices) implanted with a variety of cTDR designs were assessed by 6 investigators including clinicians and scientists experienced in cTDR or appendicular skeleton joint replacement. The overall agreement of assessments ranged from 49.9% (95% bootstrap confidence interval 45.1-73.1%) to 94.7% (95% CI 86.9-100.0%). There was reasonable agreement on the presence or absence of bone loss or radiolucencies (range: 58.4% (95% CI 51.5-82.7%) to 94.7% (95% CI 86.9-100.0%), as well as in the progression of radiolucent lines (82.9% (95% CI 74.4-96.5%)). CONCLUSIONS: The novel classification system proposed demonstrated good concordance among experienced investigators in this field and represents a useful advancement for improving reporting in cTDR studies.

Presentation and management of infection in total disc replacement: A review.

Background: Total disc replacement (TDR) is widely used in the treatment of cervical and lumbar spine pathologies. Although TDR infection, particularly delayed infection, is uncommon, the results can be devastating, and consensus on clinical management remains elusive. In this review of the literature, we asked: (1) What are the reported rates of TDR infection; (2) What are the clinical characteristics of TDR infection; and (3) How has infection been managed for TDR patients? Methods: We performed a search of the literature using PubMed and Embase to identify studies that reported TDR infection rates, the identification and management of TDR infection, or TDR failures with positive cultures. Twenty database studies (17 focusing on the cervical spine and 3 on the lumbar spine) and 10 case reports representing 15 patients were reviewed along with device Summary of Safety and Effectiveness Data reports. Results: We found a lack of clarity regarding how infection was diagnosed, indicating a variation in clinical approach and highlighting the need for a standard definition of TDR infection. Furthermore, while reported infection rates were low, the absence of a clear definition prevented robust data analysis and may contribute to underreporting in the literature. We found that treatment strategy and success rely on several factors including patient symptoms and time to onset, microorganism type, and implant positioning/stability. Conclusions: Although treatment strategies varied throughout the extant literature, common practices in eliminating infection and reconstructing the spine emerged. The results will inform future work on the creation of a more robust definition of TDR infection and as well as recommendations for management.

A review of wear debris in thumb base joint implants.

AIM: Polymers and metals, such as polyethylene (PE) and cobalt chrome (CoCr), are common materials used in thumb-based joint implants, also known as CMC (Carpometacarpal) arthroplasty. The purpose of this review was to investigate the reported failure modes related to wear debris from these type of materials in CMC implants. The impact of wear debris on clinical outcomes of CMC implants was also examined. Potential adverse wear conditions and inflammatory particle characteristics were also considered. METHOD: A literature search was performed using PRISMA guidelines and 55 studies were reviewed including 49 cohort studies and 6 case studies. Of the 55 studies, 38/55 (69%) focused on metal-on-polyethylene devices, followed by metal-on-metal (35%), and metal-on-bone (4%). RESULTS: The summarized data was used to determine the frequency of failure modes potentially related to wear debris from metals and/or polymers. The most commonly reported incidents potentially relating to debris were implant loosening (7.1%), osteolysis (1.2%) and metallosis (0.6%). Interestingly the reported mechanisms behind osteolysis and loosening greatly varied. Inflammatory reactions, while rare, were generally attributed to metallic debris from metal-on-metal devices. Mechanisms of adverse wear conditions included implant malpositioning, over-tensioning, high loading for active patients, third-body debris, and polyethylene wear-through. No specific examination of debris particle characterization was found, pointing to a gap in the literature. CONCLUSION: This review underscores the types of failure modes associated with wear debris in CMC implants. It was found that failure rates and adverse wear conditions of CMC implants of any design are low and the exact relationship between wear debris and implant incidences, such as osteolysis and loosening remains uncertain. The authors note that further research and specific characterization is required to understand the relationship between debris and implant failure.

What Are the Mortality, Infection, and Nonunion Rates After Periprosthetic Femoral Fractures in the United States?

BACKGROUND: Periprosthetic femoral fractures are a serious complication that put a high burden on patients. However, comprehensive analyses of their incidence, mortality, and complication rates based on large-registry data are scarce. QUESTIONS/PURPOSES: In this large-database study, we asked: (1) What is the incidence of periprosthetic femoral fractures in patients 65 years and older in the United States? (2) What are the rates of mortality, infection, and nonunion, and what factors are associated with these outcomes? METHODS: In this retrospective, comparative, large-database study, periprosthetic femoral fractures occurring between January 1, 2010, and December 31, 2019, were identified from Medicare physician service records encompassing services rendered in medical offices, clinics, hospitals, emergency departments, skilled nursing facilities, and other healthcare institutions from approximately 2.5 million enrollees. These were grouped into proximal, distal, and shaft fractures after TKA and THA. We calculated the incidence of periprosthetic femur fractures by year. Incidence rate ratios (IRR) were calculated by dividing the incidence in 2019 by the incidence in 2010. The Kaplan-Meier method with Fine and Gray subdistribution adaptation was used to calculate the cumulative incidence rates of mortality, infection, and nonunion. Semiparametric Cox regression was applied with 23 measures as covariates to determine factors associated with these outcomes. RESULTS: From 2010 to 2019, the incidence of periprosthetic femoral fractures increased steeply (TKA for distal fractures: IRR 3.3 [95% CI 1 to 9]; p = 0.02; THA for proximal fractures: IRR 2.3 [95% CI 1 to 4]; p = 0.01). One-year mortality rates were 23% (95% CI 18% to 28%) for distal fractures treated with THA, 21% (95% CI 19% to 24%) for proximal fractures treated with THA, 22% (95% CI 19% to 26%) for shaft fractures treated with THA, 21% (95% CI 18% to 25%) for distal fractures treated with TKA , 22% (95% CI 17% to 28%) for proximal fractures treated with TKA, and 24% (95% CI 19% to 29%) for shaft fractures treated with TKA. The 5-year mortality rate was 63% (95% CI 54% to 70%) for distal fractures treated with THA, 57% (95% CI 54% to 62%) for proximal fractures treated with THA, 58% (95% CI 52% to 63%) for shaft fractures treated with THA, 57% (95% CI 52% to 62%) for distal fractures treated with TKA , 57% (95% CI 49% to 65%) for proximal fractures treated with TKA, and 57% (95% CI 49% to 64%) for shaft fractures treated with TKA. Age older than 75 years, male sex, chronic obstructive pulmonary disease (HR 1.48 [95% CI 1.32 to 1.67] after THA and HR 1.45 [95% CI 1.20 to 1.74] after TKA), cerebrovascular disease after THA, chronic kidney disease (HR 1.28 [95% CI 1.12 to 1.46] after THA and HR 1.50 [95% CI 1.24 to 1.82] after TKA), diabetes mellitus, morbid obesity, osteoporosis, and rheumatoid arthritis were clinical risk factors for an increased risk of mortality. Within the first 2 years, fracture-related infections occurred in 5% (95% CI 4% to 7%) of patients who had distal fractures treated with THA, 5% [95% CI 5% to 6%]) of patients who had proximal fractures treated with THA, 6% (95% CI 5% to 7%) of patients who had shaft fractures treated with THA, 6% (95% CI 5% to 7%) of patients who had distal fractures treated with TKA , 7% (95% CI 5% to 9%) of patients who had proximal fractures treated with TKA, and 6% (95% CI 4% to 8%) of patients who had shaft fractures treated with TKA. Nonunion or malunion occurred in 3% (95% CI 2% to 4%) of patients with distal fractures treated with THA, 1% (95% CI 1% to 2%) of patients who had proximal fractures treated with THA, 2% (95% CI 1% to 3%) of patients who had shaft fractures treated with THA, 4% (95% CI 3% to 5%) of those who had distal fractures treated with TKA, , 2% (95% CI 1% to 4%) of those who had proximal fractures treated with TKA, and 3% (95% CI 2% to 4%) of those who had shaft fractures treated with TKA. CONCLUSION: An increasing number of periprosthetic fractures were observed during the investigated period. At 1 and 5 years after periprosthetic femur fracture, there was a substantial death rate in patients with Medicare. Conditions including cerebrovascular illness, chronic kidney disease, diabetes mellitus, morbid obesity, osteoporosis, and rheumatoid arthritis are among the risk factors for increased mortality. After the surgical care of periprosthetic femur fractures, the rates of fracture-related infection and nonunion were high, resulting in a serious risk to affected patients. Patient well-being can be enhanced by an interdisciplinary team in geriatric traumatology and should be improved to lower the risk of postoperative death. Additionally, it is important to ensure that surgical measures to prevent fracture-related infections are followed diligently. Furthermore, there is a need to continue improving implants and surgical techniques to avoid often-fatal complications such as fracture-associated infections and nonunion, which should be addressed in further studies. LEVEL OF EVIDENCE: Level III, therapeutic study.

Are Corrosion and Material Loss a Threat for Titanium-Titanium Tapers in Total Hip Arthroplasty Modular Acetabular Components?

BACKGROUND: Extensive research has reported on fretting corrosion and material loss for a variety of metal taper interfaces in orthopedic devices. For modular acetabular shell-liner constructs, the interfaces studied thus far have consisted of mixed-metal pairings, and the risk of fretting corrosion and material loss for the all-titanium (Ti) shell-liner taper junction in one ceramic-on-ceramic (COC) design remains poorly understood. We asked: do Ti shell-liner taper interfaces in COC total hip arthroplasty devices show in vivo evidence of (1) fretting and/or corrosion, and (2) quantifiable potential material loss? METHODS: We examined 22 shell-liner pairs and 22 single liners from retrieved COC components. The taper interface surfaces were assessed for fretting corrosion using a semiquantitative scoring method and imaged with scanning electron microscopy. A subcohort of components was measured with a coordinate measuring machine, and volumetric material loss and maximum wear depth were calculated. RESULTS: Fretting corrosion at the taper interfaces was minimal to mild for 95% of liners and 100% of shells. Imaging revealed fretting marks within a band of corrosion on some implants and evidence of corrosion not in the proximity of mechanical damage. Estimated material loss ranged from 0.2 to 1.3 mm3 for liners, and 0.5 to 1.1 mm3 for shells. Maximum wear depth for all components was 0.03 mm or less. CONCLUSIONS: Our results indicate that, compared to other taper junctions in total joint arthroplasty, the risk of corrosion and material loss may be minimal for Ti shell-liner interfaces.

Complications and associated risk factors after surgical management of proximal femoral fractures.

Aims: This work aimed at answering the following research questions: 1) What is the rate of mechanical complications, nonunion and infection for head/neck femoral fractures, intertrochanteric fractures, and subtrochanteric fractures in the elderly USA population? and 2) Which factors influence adverse outcomes? Methods: Proximal femoral fractures occurred between 1 January 2009 and 31 December 2019 were identified from the Medicare Physician Service Records Data Base. The Kaplan-Meier method with Fine and Gray sub-distribution adaptation was used to determine rates for nonunion, infection, and mechanical complications. Semiparametric Cox regression model was applied incorporating 23 measures as covariates to identify risk factors. Results: Union failure occured in 0.89% (95% confidence interval (CI) 0.83 to 0.95) after head/neck fracturs, in 0.92% (95% CI 0.84 to 1.01) after intertrochanteric fracture and in 1.99% (95% CI 1.69 to 2.33) after subtrochanteric fractures within 24 months. A fracture-related infection was more likely to occur after subtrochanteric fractures than after head/neck fractures (1.64% vs 1.59%, hazard ratio (HR) 1.01 (95% CI 0.87 to 1.17); p < 0.001) as well as after intertrochanteric fractures (1.64% vs 1.13%, HR 1.31 (95% CI 1.12 to 1.52); p < 0.001). Anticoagulant use, cerebrovascular disease, a concomitant fracture, diabetes mellitus, hypertension, obesity, open fracture, and rheumatoid disease was identified as risk factors. Mechanical complications after 24 months were most common after head/neck fractures with 3.52% (95% CI 3.41 to 3.64; currently at risk: 48,282). Conclusion: The determination of complication rates for each fracture type can be useful for informed patient-clinician communication. Risk factors for complications could be identified for distinct proximal femur fractures in elderly patients, which are accessible for therapeutical treatment in the management.

In Vitro Wear of a Novel Vitamin E Crosslinked Polyethylene Lumbar Total Joint Replacement.

BACKGROUND: A novel, lumbar total joint replacement (TJR) design has been developed to treat degeneration across all three columns of the lumbar spine (anterior, middle, and posterior columns). Thus far, there has been no in vitro studies that establish the preclinical safety profile of the vitamin E-stabilized highly crosslinked polyethylene (VE-HXLPE) lumbar TJR relative to historical lumbar anterior disc replacement for the known risks of wear and impingement faced by all motion preserving designs for the lumbar spine. QUESTIONS/PURPOSE: In this study we asked, (1) what is the wear performance of the VE-HXLPE lumbar TJR under ideal, clean conditions? (2) Is the wear performance of VE-HXLPE in lumbar TJR sensitive to more aggressive, abrasive conditions? (3) How does the VE-HXLPE lumbar TJR perform under impingement conditions? METHOD: A lumbar TJR with bilateral VE-HXLPE superior bearings and CoCr inferior bearings was evaluated under clean, impingement, and abrasive conditions. Clean and abrasive testing were guided by ISO 18192-1 and impingement was assessed as per ASTM F3295. For abrasive testing, CoCr components were scratched to simulate in vivo abrasion. The devices were tested for 10 million cycles (MC) under clean conditions, 5 MC under abrasion, and 1 MC under impingement. RESULT: Wear rates under clean and abrasive conditions were 1.2 ± 0.5 and 1.1 ± 0.6 mg/MC, respectively. The VE-HXLPE components demonstrated evidence of burnishing and multidirectional microscratching consistent with microabrasive conditions with the cobalt chromium spherical counterfaces. Under impingement, the wear rates ranged between 1.7 ± 1.1 (smallest size) and 3.9 ± 1.1 mg/MC (largest size). No functional or mechanical failure was observed across any of the wear modes. CONCLUSIONS: Overall, we found that that a VE-HXLPE-on-CoCr lumbar total joint replacement design met or exceeded the benchmarks established by traditional anterior disc replacements, with wear rates previously reported in the literature ranging between 1 and 15 mg/MC. CLINICAL RELEVANCE: The potential clinical benefits of this novel TJR design, which avoids long-term facet complications through facet removal with a posterior approach, were found to be balanced by the in vitro tribological performance of the VE-HXLPE bearings. Our encouraging in vitro findings have supported initiating an FDA-regulated clinical trial for the design which is currently under way.

Epidemiology and treatment of proximal femoral fractures in the elderly U.S. population.

Proximal femoral fractures are a serious complication, especially for elderly patients. Detailed epidemiological analyzes provide a valuable resource for stakeholders in the health care system in order to foresee future development possibly influenceable by adaption of therapeutic procedures and prevention strategies. This work aimed at answering the following research questions: (1) What are the incidence rates of proximal femoral fractures in the elderly U.S. population? (2) What is the preferred treatment procedure for these fractures? Proximal femoral fractures occurred between January 1, 2009 and December 31, 2019 in patients ≥ 65 years were identified from the Medicare Physician Service Records Data Base. The 5% sample of Medicare beneficiaries, equivalent to the records from approximately 2.5 million enrollees formed the basis of this study. Fractures were grouped into head/neck, intertrochanteric, and subtrochanteric fractures. The overall incidence rate, age and sex specific incidence rates as well as incidence rate ratios were calculated. Common Procedural Terminology (CPT) codes were used to identify procedures and operations. In 2019, a total number of 7982 femoral head/neck fractures was recorded. In comparison to 9588 cases in 2009, the incidence substantially decreased by 26.6% from 666.7/100,000 inhabitants to 489.3/100,000 inhabitants (z = - 5.197, p < 0.001). Also, in intertrochanteric fractures, a significant decline in the incidence by 17.3% was evident over the years from 367.7/100,000 inhabitants in 2009 to 304.0 cases per 100,000 inhabitants in 2019 (z = - 2.454, p = 0.014). A similar picture was observable for subtrochanteric fractures, which decreased by 29.6% (51.0 cases per 100,000 to 35.9 cases per 100,000) over the time period (z = - 1.612, p = 0.107). Head/neck fractures were mainly treated with an arthroplasty (n = 36,301, 40.0%). The majority of intertrochanteric fractures and subtrochanteric fractures received treatment with an intramedullary device (n = 34,630, 65.5% and n = 5870, 77.1%, respectively). The analysis indicated that the incidence of all types of proximal femoral neck fractures decreased for the population of elderly patients in the U.S. within the last decade. Treatment of head and neck fractures was mainly conducted through arthroplasty, while intertrochanteric and subtrochanteric fractures predominantly received an intramedullary nailing.

Taguchi optimization of 3D printed short carbon fiber polyetherketoneketone (CFR PEKK).

In this study, the Taguchi method was utilized to optimize fused filament fabrication (FFF) additive manufacturing with the goal of maximizing the flexural strength of 3D printed polyaryletherketone specimens. We analyzed 3D printed (3DP) carbon fiber reinforced poly-etherketoneketone (CFR PEKK), 3D printed and pressed (3DP + P) CFR PEKK, and injection molded medical grade polyetheretherketone (PEEK) as a control. Fracture surfaces were analyzed via scanning electron microscopy (SEM). The parameters that were varied in the optimization included nozzle diameter, layer height, print speed, raster angle, and nozzle temperature. We analyzed the flexural strength and flexural modulus determined from 3-point bending (ASTM D790). Using Taguchi optimization, the signal to noise ratio (SNR) was calculated to determine the relationship between the input parameters and flexural strength and to determine optimal print settings. Results were confirmed with analysis of variance (ANOVA). The raster angle and layer height were determined to have the greatest impact on the flexural strength of specimens printed in the FFF process for 3DP CFR PEKK. The optimized printing parameters were found to be 0/90 Raster Angle, 0.25 mm layer height, 0.8 mm Nozzle Diameter, 375 °C nozzle temperature, and 1100 mm/min print speed. The optimized 3DP CFR PEKK test samples had a flexural strength of 111.3 ± 5.3 MPa and a flexural modulus of 3.5 GPa. 3DP + P CFR PEKK samples had a flexural strength of 257.2 ± 17.8 MPa and a flexural modulus of 8.2 GPa. Statistical comparisons between means demonstrated that pressing significantly improves both flexural strength and flexural modulus of 3DP CFR PEKK. The results of this study support the hypothesis that post consolidation of 3DP specimens improves mechanical properties. Post-processing composites via pressing may allow greater design freedom within the 3DP process while improving mechanical properties.

Proximal Humerus Fractures in the Elderly U.S. Population: A Cross-Sectional Study of Treatment Trends and Comparison of Complication Rates after Joint Replacement, Open Reduction and Internal Fixation, and Non-Surgical Management.

Proximal humerus fracture (PHF) treatment remains challenging. Multiple therapy options exist, and the optimal choice of management has been increasingly discussed in the literature. The aim of this study was to (1) analyze trends in the propensity of proximal humerus fracture treatments and (2) compare complication rates after joint replacement, surgical repair, and non-surgical treatment in terms of mechanical complications, union failure, and infection rates. In this cross-sectional study, patients aged 65 years or older with proximal humerus fractures occurring between 1 January 2009 and 31 December 2019 were identified from Medicare physician service claims records. The Kaplan-Meier method with the Fine and Gray adjustment was used to calculate the cumulative incidence rates for malunion/nonunion, infection, and mechanical complications for the following treatment categories: shoulder arthroplasty, open reduction and internal fixation (ORIF), and non-surgical treatment, respectively. Semiparametric Cox regression was performed incorporating 23 demographic, clinical, and socioeconomic covariates to determine risk factors. Between 2009 through 2019, conservative procedures decreased by 0.9%. ORIF procedures decreased from 9.51% (95% CI: 8.7-10.4) to 6.95% (95% CI: 6.2-7.7), whereas shoulder arthroplasties rose from 1.99% (95% CI: 1.6-2.4), to 5.45% (95% CI: 4.8-6.2). PHFs managed through ORIF were associated with higher union failure rates compared to conservatively treated fractures (HR = 1.31, 95% CI: 1.15-1.5, p < 0.001). The risk of developing an infection was increased after joint replacement compared to ORIF (2.66% vs. 1.09%, HR = 2.09, 95% CI: 1.46-2.98, p < 0.001). Mechanical complications were more common after joint replacement (6.37% vs. 4.85%, HR = 1.66, 95% CI: 1.32-2.09, p < 0.001). Complication rates differed significantly across treatment modalities. This should be considered when choosing a management procedure. Vulnerable elderly patient cohorts could be identified, and the optimization of modifiable risk factors might lead to a decrease of complication rates in both surgically and non-surgically treated patients.

In Vitro and In Vivo Evaluation of Ultrasound-Triggered Release From Novel Spinal Device.

OBJECTIVES: Bacterial infection following spinal fusion is a major clinical concern with up to 20% incidence. An ultrasound-triggered bulk-release system to combat postsurgical bacterial survival was designed and evaluated. METHODS: Polylactic acid (PLA) clips were loaded with vancomycin (VAN) and microbubbles (Sonazoid, GE HealthCare) in vitro. Stability was determined over 14 days. VAN-loaded clips were submerged in water and insonated using a Logiq E10 scanner (GE HealthCare) with a curvilinear C6 probe. Doppler-induced VAN release was quantified using spectrophotometry. For in vivo testing, clips were loaded with methylene blue (MeB) solution and Sonazoid. These clips were implanted into a rabbit along the spine at L2 and L5, as well as a pig at L1 and L3, then insonated in Doppler mode using the C6 probe. RESULTS: Sonazoid microbubbles were better preserved when incubated in VAN compared with distilled water at 4°C, 25°C, and 37°C incubation temperatures (P = .0131). Contrast enhancement was observed from both solutions when incubated at 4°C storage conditions. Insonated clips achieved average cumulative VAN release of 101.8 ± 2.8% (81.4 ± 2.8 mg) after 72 hours. Uninsonated clips had only 0.3 ± 0.1% (0.3 ± 0.1 mg) average cumulative VAN release (P < .0001). Clips retrieved from the rabbit did not rupture with insonation nor produce MeB staining of surrounding tissues. In the pig, the PLA film was visibly ruptured and MeB tissue was observed following insonation, whereas the uninsonated clip was intact. CONCLUSION: These results demonstrate ultrasound-triggered release of an encapsulated prophylactic solution and provide an important proof-of-concept for continuing large animal evaluations for translational merit.

Femoral shaft fractures in eldery patients - An epidemiological risk analysis of incidence, mortality and complications.

OBJECTIVES: This work aimed at answering the following research questions: (1) What is the incidence of femoral shaft fractures in the geriatric population in the U.S.? (2) What is the rate of mortality, mechanical complications, nonunion and infection, and what are the associated risk factors? STUDY DESIGN AND SETTING: In this cross-sectional study, femoral shaft fractures occurred between January 1, 2009, and December 31, 2019, were identified from Medicare records. Rates of mortality, nonunion, infection, and mechanical complications were calculated with the Kaplan-Meier method with Fine and Gray sub-distribution adaptation. Semiparametric Cox regression was applied with twenty-three covariates to determine risk factors. RESULTS: Between 2009 through 2019 the incidence of femoral shaft fractures decreased by 12.07% to 40.8/100,000 inhabitants (p = 0.549). The 5-year mortality risk was 58.5%. Male sex, age over 75 years, chronic obstructive pulmonary disease, cerebrovascular disease, chronic kidney disease, congestive heart failure, diabetes mellitus, osteoporosis, tobacco dependence, and lower median household income were significant risk factors. The infection rate was 2.22% [95%CI: 1.90-2.58] and the union failure rate 2.52% [95%CI: 2.17-2.92] after 24 months. CONCLUSION: An early assessment of individual patient risk factors may be beneficial in the care and treatment of patients with these fractures.

Ceramic Wear Particles: Can They Be Retrieved In Vivo and Duplicated In Vitro?

BACKGROUND: Little is known about retrieved zirconia platelet toughened alumina (ZPTA) wear particles from ceramic-on-ceramic (COC) total hip arthroplasty. Our objectives were to evaluate clinically retrieved wear particles from explanted periprosthetic hip tissues and to analyze the characteristics of in vitro-generated ZPTA wear particles. METHODS: Periprosthetic tissue and explants were received for 3 patients who underwent a total hip replacement of ZPTA COC head and liner. Wear particles were isolated and characterized via scanning electron microscopy and energy dispersive spectroscopy. The ZPTA and control (highly cross-linked polyethylene and cobalt chromium alloy) were then generated in vitro using a hip simulator and pin-on-disc testing, respectively. Particles were assessed in accordance with American Society for Testing and Materials F1877. RESULTS: Minimal ceramic particles were identified in the retrieved tissue, consistent with the retrieved components demonstrating minimal abrasive wear with material transfer. Average particle diameter from in vitro studies was 292 nm for ZPTA, 190 nm for highly cross-linked polyethylene, and 201 nm for cobalt chromium alloy. CONCLUSION: The minimal number of in vivo ZPTA wear particles observed is consistent with the successful tribological history of COC total hip arthroplasties. Due to the relatively few ceramic particles located in the retrieved tissue, in part due to implantation times of 3 to 6 years, a statistical comparison was unable to be made between the in vivo particles and the in vitro-generated ZPTA particles. However, the study provided further insight into the size and morphological characteristics of ZPTA particles generated from clinically relevant in vitro test setups.

A Review of Early In Vivo Performance of Antioxidant Stabilized Polyethylene for Total Knee Arthroplasty.

BACKGROUND: The incorporation of antioxidants into highly cross-linked polyethylene (HXLPE) has emerged as an alternative to postirradiation thermal treatments for improving oxidation resistance. Currently, use of antioxidant stabilized HXLPE (AO-XLPE) in total knee arthroplasty (TKA) is increasing. In this literature review, we asked: (1) How does the clinical performance of AO-XLPE compare to conventional ultra-high molecular weight polyethylene (UHMWPE) or HXLPE for TKA? (2) What material changes occur in vivo for AO-XLPE in TKA? and (3) What is the risk of revision for AO-XLPE in TKA? METHODS: We performed a search of the literature according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines using PubMed and Embase. Included studies reported the in vivo behavior of vitamin E-doped polyethylene in TKA. We reviewed 13 studies. RESULTS: Across the studies, clinical results including revision rates, patient-reported outcome measurement scores, and the occurrence of osteolysis or radiolucent lines tended to be similar for AO-XLPE as compared to conventional UHMWPE or HXLPE controls. In retrieval analyses, AO-XLPE exhibited excellent resistance to oxidation and typical surface damage. Survival rates were positive and not significantly different from conventional UHMWPE or HXLPE. There were no cases of osteolysis for AO-XLPE and no revision due to polyethylene wear reported. CONCLUSION: The purpose of this review was to provide a comprehensive overview of the literature regarding the clinical effectiveness of AO-XLPE in TKA. Overall, the results of our review indicated positive early-to mid-term clinical performance for AO-XLPE in TKA and similar outcomes as compared to conventional UHMWPE and HXLPE.

Proximal humerus fractures - epidemiology, comparison of mortality rates after surgical versus non-surgical treatment, and analysis of risk factors based on Medicare registry data.

AIMS: The optimal choice of management for proximal humerus fractures (PHFs) has been increasingly discussed in the literature, and this work aimed to answer the following questions: 1) what are the incidence rates of PHF in the geriatric population in the USA; 2) what is the mortality rate after PHF in the elderly population, specifically for distinct treatment procedures; and 3) what factors influence the mortality rate? METHODS: PHFs occurring between 1 January 2009 and 31 December 2019 were identified from the Medicare physician service records. Incidence rates were determined, mortality rates were calculated, and semiparametric Cox regression was applied, incorporating 23 demographic, clinical, and socioeconomic covariates, to compare the mortality risk between treatments. RESULTS: From 2009 to 2019, the incidence decreased by 11.85% from 300.4 cases/100,000 enrollees to 266.3 cases/100,000 enrollees, although this was not statistically significant (z = -1.47, p = 0.142). In comparison to matched Medicare patients without a PHF, but of the same five-year age group and sex, a mean survival difference of -17.3% was observed. The one-year mortality rate was higher after nonoperative treatment with 16.4% compared to surgical treatment with 9.3% (hazard ratio (HR) = 1.29, 95% confidence interval (CI) 1.23 to 1.36; p < 0.001) and to shoulder arthroplasty with 7.4% (HR = 1.45, 95% CI 1.33 to 1.58; p < 0.001). Statistically significant mortality risk factors after operative treatment included age older than 75 years, male sex, chronic obstructive pulmonary disease (COPD), cerebrovascular disease, chronic kidney disease, a concomitant fracture, congestive heart failure, and osteoporotic fracture. CONCLUSION: Mortality risk factors for distinct treatment modes after PHF in elderly patients could be identified, which may guide clinical decision-making.Cite this article: Bone Joint Res 2023;12(2):103-112.

Short-Term Surface Damage Mechanisms of Retrieved Highly Cross-Linked Polyethylene Patellar Components.

BACKGROUND: Previous retrieval studies of patellar components for total knee arthroplasty focused on historical designs and polyethylene materials that are no longer clinically relevant. Therefore, this study aimed to compare revision reasons and surface damage mechanisms of conventional, gamma inert sterilized polyethylene and highly cross-linked polyethylene (HXLPE) patellar components in contemporary designs from a single manufacturer. METHODS: A total of 114 gamma inert and 76 HXLPE patellar components were gathered in a multicenter orthopaedic implant retrieval program. Patient age and body mass index were similar between cohorts (P = .27 and P = .42, respectively); however, the gamma inert cohort was implanted longer (µdifference = 3.1 years; P = .005). A matched subset was created based on the total knee arthroplasty design, patellar shape, and implantation time. Revision reasons were gathered from revision operating notes, and surface damage was examined via the Hood scoring method. Differences between HXLPE and gamma inert cohorts were evaluated using Mann-Whitney U-tests. RESULTS: The most common revision reasons were infection, loosening, and instability, with the most common patellar complication resulting in revision being patellar loosening for both cohorts with similar incidences for both (chi-square; P = .60, P = .59). The most common surface damage modes were burnishing, scratching, and pitting in both cohorts. Total surface damage was significantly higher in the gamma inert components (P = .02), but not in the matched subset (P = .46). CONCLUSION: Overall, the clinical performance of HXLPE was similar to that of conventional polyethylene for patellar components with short implantation times. While this study provides much needed information on the performance of HXLPE patellae in short-term retrievals, long-term studies are still needed.

In Vivo Performance of Vitamin E Stabilized Polyethylene Implants for Total Hip Arthroplasty: A Review.

BACKGROUND: Vitamin E stabilization was introduced to improve the oxidative stability, wear resistance, and mechanical properties of highly crosslinked polyethylene (HXLPE). In this literature review, we asked: (1) How has vitamin E-stabilized HXLPE (VEPE) performed in vivo for total hip arthroplasty (THA) and how does it compare with conventional ultra-high molecular weight polyethylene (UHMWPE) and HXLPE without vitamin E; and (2) Is there an apparent difference in the clinical performance of VEPE created by blending versus diffusion? METHODS: We performed a systematic search of the literature according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines using PubMed and Embase. Included studies reported the in vivo behavior of VEPE in THA. We reviewed 41 studies. RESULTS: For all studies that compared polyethylene with and without VE stabilization, outcomes for VEPE were either equivalent or superior to the control group (for HXLPE without VE and conventional UHMWPE controls, respectively). Hip insert wear rates were generally less than 0.1 mm/year and in most cases were less than 0.05 mm/year. No VEPE components were revised for osteolysis or adverse outcomes specific to VE incorporation. CONCLUSION: Across the literature, we found that VEPE was reported to be clinically effective for THA applications, with much of the research indicating positive clinical outcomes and lower or equivalent wear rates compared to conventional UHMWPE and HXLPE controls without VE. Instances of early component fracture were reported, but have multiple potential causes. There is a gap in the literature for comparison of blended and diffused components, so the in vivo impact of VE incorporation method remains to be seen. Overall, this study provides a comprehensive summary of VEPE clinical performance for THA and may serve as a resource for future investigations.

Patient Perceptions of Wearable and Smartphone Technologies for Remote Outcome Monitoring in Total Knee Arthroplasties.

While there is enthusiasm for wearables and smartphone technologies in evaluating clinical outcomes among clinicians, less is known about the willingness of patients who have osteoarthritis (OA) to consent for remote outcome monitoring. We developed an Institutional Review Board-approved questionnaire to assess patient perceptions of remote monitoring technologies in a high-volume orthopaedic clinical center. Fifty total knee arthroplasty (TKA) patients (56% female; mean age: 61 years, range: 23-89) and fifty nonoperative OA knee patients (54% female; mean age: 58 years, range: 25-89) routinely consulted in the clinic as part of their OA treatment and consented to participate in the study. Patient perceptions were compared using Pearson's chi-square analyses with a significance threshold of p < 0.05. We found that TKA patients were more receptive to the use of smartphone apps (84 vs. 60%, p = 0.008) and wearable sensors (80 vs. 48%, p < 0.001) and learning to use custom wearables (72 vs. 38%, p = 0.002) than nonoperative OA knee patients as part of their treatment. Likewise, the majority of TKA patients were willing to use the global positioning system in their postoperative technology (54 vs. 18%, p < 0.001), especially if they were only active during certain circumstances (62 vs. 24%, p < 0.001). TKA patients also expressed willingness to have their body movement (68%), balance (70%), sleep (76%), and cardiac output (80%) tracked using remote technologies. Overall, we found that TKA patients were highly receptive to using wearable technology in their treatments, whereas nonoperative OA knee patients were generally unreceptive. Our study challenges the concept that current wearable technology approaches will be generally effective as a tool to remotely monitor all patients across the OA severity landscape.

Revision Rates and Associated Risk Factors after Shoulder Arthroplasty.

This study aims at answering the following questions (1) How high is the revision rate after osteoarthritis-, and rotator cuff-related compared to proximal humerus fracture (PHF)-related shoulder arthroplasty? (2) What are the associated risk factors for a revision after shoulder arthroplasty? Shoulder arthroplasty procedures occurring between 1 January 2009 and 31 December 2019 were identified from the Medicare database. First, revision rates for PHF patients and age- and sex-matched non-fracture patients, grouped into osteoarthritis-related and rotator cuff-related arthroplasty, were compared. Second, revision rates between total shoulder arthroplasty and hemiarthroplasty after PHF were compared. Semiparametric Cox regression was applied, incorporating 23 demographic, clinical, and socioeconomic covariates, to investigate risk factors for revision surgery. Between the considered time period from 2009 through 2019, a total number of 47,979 PHFs was identified. A shoulder arthroplasty procedure was performed in n = 2639 (5.5%, 95%CI: 4.8-6.1) of the cases. The five-year survivorship of the implant was 96.3 (95%CI: 93.8-97.9) after hemiarthroplasty and 96.1% (05%CI: 94.2-97.3) after total shoulder arthroplasty. To compare the revision rates, n = 14,775 patients with osteoarthritis and n = 4268 patients with rotator cuff arthropathy, who received a shoulder arthroplasty, served as a non-fracture control group. Patients receiving a rotator cuff-related arthroplasty were more likely to require a revision compared to patients treated for osteoarthritis (HR: 1.27, 95%CI: 1.04-1.44, p = 0.018). Identified significant risk factors for revision surgery after shoulder arthroplasty included age ≤ 75 years, male sex, and osteoporosis. High implant survival was found for hemiarthroplasty and total shoulder arthroplasty for the treatment of PHF in elderly patients. The risk of revision surgery was elevated in patients receiving a rotator cuff-related arthroplasty as well as in patients with osteoporosis, male patients and patients older than 75 years.

State and Government Administrative Databases: Medicare, National Inpatient Sample (NIS), and State Inpatient Databases (SID) Programs.

The availability of large state and federally run administrative health-care databases provides potentially comprehensive population-wide information that can dramatically impact both medical and health-policy decision-making. Specific opportunities and important limitations exist with all administrative databases based on what information is collected and how reliably specific data elements are reported. Access to patient identifiable-level information can be critical for certain long-term outcome studies but can be difficult (although not impossible) due to patient privacy protections, while more easily available de-identified information can provide important insights that may be more than sufficient for some short-term operative or in-hospital outcome questions. The first section of this paper by Sarah K. Meier and Benjamin D. Pollock discusses Medicare and the different data files available to health-care researchers. They describe what is and is not generally available from even the most granular Medicare Standard Analytic Files, and provide an analysis of the strengths and weaknesses of Medicare administrative data as well as the resulting best and inappropriate uses of these data. In the second section, the Nationwide Inpatient Sample and complementary State Inpatient Database programs are reviewed by Steven M. Kurtz and Edmund Lau, with insights into the origins of these programs, the data elements that are recorded relating to the operative procedure and hospital stay, and examples of the types of studies that optimally utilize these data sources. They also detail the limitations of these databases and identify studies that they are not well-suited for, especially those involving linkage or longitudinal studies over time. Both sections provide useful guidance on the best uses and pitfalls related to these important large representative national administrative data sources.