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1.
J Arthroplasty ; 2024 Jul 23.
Artículo en Inglés | MEDLINE | ID: mdl-39053666

RESUMEN

BACKGROUND: Previous studies identified corrosion between the modular tibial components of total knee arthroplasty devices. However, gaps persist. Compared to the hip, damage modes that occur within taper junctions in the knee remain poorly understood. In this study, we investigated corrosion on total knee arthroplasty components with titanium-titanium junctions. We asked the following question: under typical in vivo cyclic loading conditions, will the same alloy damage modes from total knee arthroplasty devices resemble those documented in the hip? METHODS: A total of 50 paired titanium alloy tibial baseplates and stems were collected and semiquantitatively analyzed using Goldberg corrosion scoring. To characterize damage, a subsection of moderately and severely corroded components was sectioned and imaged using scanning electron and digital optical microscopy. RESULTS: Of the 100 device components, 95% showed visual evidence of corrosion. The initial contact area between the stem and bore generally occurred 3 mm from the stem taper base. Scanning electron microscopy revealed 4 damage modes, including oxide film formation, crevice corrosion, selective dissolution, and pitting. CONCLUSIONS: Each of the damage modes identified in modular titanium-titanium tibial junctions was previously reported by total hip arthroplasty retrieval studies. Cumulatively, our results suggest that mechanically assisted crevice corrosion promoted this damage in vivo.

2.
J Arthroplasty ; 39(9S1): S272-S279, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39019413

RESUMEN

BACKGROUND: The first generation of titanium nitride (TiN) coatings for orthopaedic implants was clinically introduced in the 1990s because of their promising biocompatibility, wear resistance, and corrosion resistance. This study evaluated the in vivo performance of early TiN-coated knee and hip implants, focusing on the bearing surfaces and mechanisms of in vivo damage. METHODS: There were 13 TiN-coated implants (5 knee and 8 hip) retrieved from 8 patients as part of a multi-institutional implant retrieval program. The average implantation time was 4.25 years for knees and 17.5 years for hips. Implant revisions occurred for various reasons, including polyethylene wear, loosening, pain, infection, and instability. Components were examined using a semiquantitative scoring method, and surface roughness measurements were performed using white-light interferometry. Surface morphology, chemistry, and particle characterization were also assessed by scanning electron microscopy. RESULTS: For hips, mild corrosion was found on femoral head tapers, along with severe scratching on certain femoral heads. Knee implants exhibited low burnishing and scratching for both mechanisms. Roughness measurements (Sa) were 37.3 nm (interquartile range = 22.0 to 62.4) for hips and 85.3 nm (interquartile range = 66.3 to 110) for knees. The observed scratch depth in both hip and knee implants due to third-body particles ranged from 0.3 to 1.3 µm. The coating coverage remained intact in the majority of the implants, with 2 cases of small, localized cohesive chipping and substrate exposure. CONCLUSIONS: The results of this study confirm the potential in vivo durability of early TiN coatings and will be useful in benchmarking wear tests for modern TiN-coated orthopaedic implants.


Asunto(s)
Materiales Biocompatibles Revestidos , Prótesis de Cadera , Prótesis de la Rodilla , Falla de Prótesis , Propiedades de Superficie , Titanio , Humanos , Materiales Biocompatibles Revestidos/química , Anciano , Femenino , Persona de Mediana Edad , Masculino , Remoción de Dispositivos , Artroplastia de Reemplazo de Cadera/instrumentación , Artroplastia de Reemplazo de Rodilla/instrumentación , Diseño de Prótesis , Corrosión , Reoperación , Microscopía Electrónica de Rastreo
3.
Eur Spine J ; 33(8): 2969-2981, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39009847

RESUMEN

PURPOSE: Cervical total disc replacement (cTDR) has been established as an alternative treatment for degenerative cervical radiculopathy and myelopathy. While the rate of complications for cTDR is reasonably low, recent studies have focused on bone loss after cTDR. The purpose of this work is to develop a clinical management plan for cTDR patients with evidence of bone loss. To guide our recommendations, we undertook a review of the literature and aimed to determine: (1) how bone loss was identified/imaged, (2) whether pre- or intraoperative assessments of infection or histology were performed, and (3) what decision-making and revision strategies were employed. METHODS: We performed a search of the literature according to PRISMA guidelines. Included studies reported the clinical performance of cTDR and identified instances of cervical bone loss. RESULTS: Eleven case studies and 20 cohort studies were reviewed, representing 2073 patients with 821 reported cases of bone loss. Bone loss was typically identified on radiographs during routine follow-up or by computed tomography (CT) for patients presenting with symptoms. Assessments of infection as well as histological and/or explant assessment were sporadically reported. Across all reviewed studies, multiple mechanisms of bone loss were suspected, and severity and progression varied greatly. Many patients were reportedly asymptomatic, but others experienced symptoms like progressive pain and paresthesia. CONCLUSION: Our findings demonstrate a critical gap in the literature regarding the optimal management of patients with bone loss following cTDR, and treatment recommendations based on our review are impractical given the limited amount and quality evidence available. However, based on the authors' extensive clinical experience, close follow-up of specific radiographic observations and serial radiographs to assess the progression/severity of bone loss and implant changes are recommended. CT findings can be used for clinical decision-making and further follow-up care. The pattern and rate of progression of bone loss, in concert with patient symptomatology, should determine whether non-operative or surgical intervention is indicated. Future studies involving implant retrieval, histopathological, and microbiological analysis for patients undergoing cTDR revision for bone loss are needed.


Asunto(s)
Vértebras Cervicales , Reeemplazo Total de Disco , Humanos , Reeemplazo Total de Disco/métodos , Reeemplazo Total de Disco/efectos adversos , Vértebras Cervicales/cirugía , Vértebras Cervicales/diagnóstico por imagen , Resorción Ósea/diagnóstico por imagen , Resorción Ósea/etiología , Complicaciones Posoperatorias/etiología
4.
Bioengineering (Basel) ; 11(6)2024 Jun 17.
Artículo en Inglés | MEDLINE | ID: mdl-38927852

RESUMEN

Ultra-high-molecular-weight polyethylene (UHMWPE) components for orthopedic implants have historically been integrated into metal backings by direct-compression molding (DCM). However, metal backings are costly, stiffer than cortical bone, and may be associated with medical imaging distortion and metal release. Hybrid-manufactured DCM UHMWPE overmolded additively manufactured polyetheretherketone (PEEK) structural components could offer an alternative solution, but are yet to be explored. In this study, five different porous topologies (grid, triangular, honeycomb, octahedral, and gyroid) and three surface feature sizes (low, medium, and high) were implemented into the top surface of digital cylindrical specimens prior to being 3D printed in PEEK and then overmolded with UHMWPE. Separation forces were recorded as 1.97-3.86 kN, therefore matching and bettering the historical industry values (2-3 kN) recorded for DCM UHMWPE metal components. Infill topology affected failure mechanism (Type 1 or 2) and obtained separation forces, with shapes having greater sidewall numbers (honeycomb-60%) and interconnectivity (gyroid-30%) through their builds, tolerating higher transmitted forces. Surface feature size also had an impact on applied load, whereby those with low infill-%s generally recorded lower levels of performance vs. medium and high infill strategies. These preliminary findings suggest that hybrid-manufactured structural composites could replace metal backings and produce orthopedic implants with high-performing polymer-polymer interfaces.

5.
J Arthroplasty ; 2024 Jun 19.
Artículo en Inglés | MEDLINE | ID: mdl-38906197

RESUMEN

BACKGROUND: After clinical introduction in 2005, sequentially annealed, highly cross-linked polyethylene (SA HXLPE) was studied for retrievals with short implantation times; however, long-term follow-ups are lacking. The objective of this study was to examine and compare the revision reasons, damage mechanisms, and oxidation indices of SA HXLPE and conventional gamma inert-sterilized (Gamma Inert) ultra-high-molecular-weight polyethylene tibial inserts implanted for >5 years. METHODS: There were 74 total knee arthroplasty tibial inserts (46 SA HXLPEs, 28 Gamma Inerts) implanted for >5 years (mean 7 ± 2 years) retrieved as part of a multicenter retrieval program. Cruciate-retaining implants comprised 44% of the SA HXLPEs and 14% of the Gamma Inerts. Patient factors and revision reasons were collected from revision operating notes. A semiquantitative scoring method was used to assess surface damage mechanisms. Oxidation was measured using Fourier transform infrared microscopy according to American Society for Testing and Materials 2102. Differences between cohorts were assessed with Mann-Whitney U-tests. RESULTS: Loosening (Gamma Inert: 17 of 28, SA HXLPE: 15 of 46) and instability (Gamma Inert: 6 of 28, SA HXLPE: 15 of 46) were the most common revision reasons for both cohorts. The most prevalent surface damage mechanisms were burnishing, pitting, and scratching, with burnishing of the condyles being higher in Gamma Inert components (P = .022). Mean oxidation was higher in the SA HXLPE inserts at the articulating surface (P = .002) and anterior-posterior faces (P = .023). No difference was observed at the backside surface (P = .060). CONCLUSIONS: Revision reasons and surface damage mechanisms were comparable in the Gamma Inert and SA cohorts. Further studies are needed to continue to assess the in vivo damage and clinical relevance, if any, of oxidation in SA HXLPE over longer implantation times, particularly for implants implanted for more than 10 years.

6.
J Arthroplasty ; 39(9S1): S286-S291, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38754708

RESUMEN

BACKGROUND: Highly cross-linked polyethylene (HXLPE) was introduced to improve wear in total hip arthroplasty, with manufacturers implementing different thermal treatments to reduce oxidation. It is important to understand how long-term time in vivo affects the wear of these materials. The purpose of this study was to investigate the wear and oxidative performance of first-generation HXLPE hip inserts implanted for greater than 10 years and compare annealed and remelted HXLPE formulations. METHODS: There were 49 total hip arthroplasty liners retrieved during routine revision surgery as part of an institutional review board-approved implant retrieval program. Penetration rates for the liners were calculated as the difference between the thickness of the unloaded and loaded regions divided by implantation time. Oxidation indices for the rim, locking mechanism, articulating surface, and backside regions were measured using Fourier-transform infrared spectroscopy according to American Society for Testing and Materials 2102. Mann-Whitney U tests were used to determine the statistical difference between annealed and remelted components. RESULTS: The cohort had an average implantation time of 13.1 ± 2.6 years for annealed and 12.1 ± 1.7 years for remelted components. The components were revised most often for polyethylene wear, instability, and loosening. The penetration rate averaged 0.0177 ± 0.014 mm/year for annealed components and 0.015 ± 0.022 mm/year for remelted components. Penetration rates did not differ between the remelted and annealed cohorts (P = .28). Oxidation indices were found to be significantly higher in the annealed cohort for all regions of interest (P < .001). CONCLUSIONS: Oxidation was found to be higher in the annealed HXLPE; however, this does not seem to be associated with greater wear as we found the average penetration rates for the cohorts were low, and the penetration rates were similar between the annealed and remelted cohorts.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Cabeza Femoral , Prótesis de Cadera , Oxidación-Reducción , Polietileno , Falla de Prótesis , Humanos , Artroplastia de Reemplazo de Cadera/instrumentación , Persona de Mediana Edad , Femenino , Masculino , Anciano , Polietileno/química , Diseño de Prótesis , Reoperación , Ensayo de Materiales , Adulto , Factores de Tiempo
7.
J Orthop Surg Res ; 19(1): 218, 2024 Apr 03.
Artículo en Inglés | MEDLINE | ID: mdl-38566203

RESUMEN

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.


Asunto(s)
Degeneración del Disco Intervertebral , Reeemplazo Total de Disco , Humanos , Resultado del Tratamiento , Discectomía , Vértebras Cervicales/diagnóstico por imagen , Vértebras Cervicales/cirugía , Cuello , Degeneración del Disco Intervertebral/cirugía
8.
N Am Spine Soc J ; 18: 100320, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38590972

RESUMEN

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.

9.
Clin Orthop Relat Res ; 482(3): 471-483, 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-37678213

RESUMEN

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.


Asunto(s)
Artritis Reumatoide , Diabetes Mellitus , Fracturas del Fémur , Obesidad Mórbida , Osteoporosis , Fracturas Periprotésicas , Insuficiencia Renal Crónica , Humanos , Masculino , Anciano , Estados Unidos/epidemiología , Fracturas Periprotésicas/epidemiología , Fracturas Periprotésicas/etiología , Fracturas Periprotésicas/cirugía , Estudios Retrospectivos , Obesidad Mórbida/complicaciones , Medicare , Fracturas del Fémur/epidemiología , Fracturas del Fémur/etiología , Fracturas del Fémur/cirugía , Fémur/cirugía , Factores de Riesgo , Osteoporosis/complicaciones , Insuficiencia Renal Crónica/complicaciones
10.
Eur J Orthop Surg Traumatol ; 34(1): 251-269, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37439887

RESUMEN

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.


Asunto(s)
Osteólisis , Humanos , Osteólisis/etiología , Pulgar/cirugía , Prótesis e Implantes/efectos adversos , Polietileno , Artroplastia/efectos adversos , Metales , Falla de Prótesis
11.
J Arthroplasty ; 2023 Dec 08.
Artículo en Inglés | MEDLINE | ID: mdl-38070717

RESUMEN

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.

12.
Bone Jt Open ; 4(10): 801-807, 2023 Oct 23.
Artículo en Inglés | MEDLINE | ID: mdl-37866820

RESUMEN

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.

13.
Bioengineering (Basel) ; 10(10)2023 Oct 15.
Artículo en Inglés | MEDLINE | ID: mdl-37892928

RESUMEN

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.

14.
Sci Rep ; 13(1): 12734, 2023 08 05.
Artículo en Inglés | MEDLINE | ID: mdl-37543668

RESUMEN

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.


Asunto(s)
Fracturas del Cuello Femoral , Fijación Intramedular de Fracturas , Fracturas de Cadera , Fracturas Femorales Proximales , Masculino , Femenino , Humanos , Anciano , Estados Unidos/epidemiología , Medicare , Fracturas de Cadera/epidemiología , Fracturas de Cadera/terapia , Fracturas de Cadera/etiología , Fracturas del Cuello Femoral/epidemiología , Fracturas del Cuello Femoral/cirugía , Fijación Intramedular de Fracturas/efectos adversos , Estudios Retrospectivos
15.
J Mech Behav Biomed Mater ; 145: 105981, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37481803

RESUMEN

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.


Asunto(s)
Impresión Tridimensional , Fibra de Carbono , Ensayo de Materiales , Propiedades de Superficie
16.
J Ultrasound Med ; 42(10): 2357-2368, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37249416

RESUMEN

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.


Asunto(s)
Poliésteres , Vancomicina , Animales , Conejos , Porcinos , Ultrasonografía , Agua
17.
J Clin Med ; 12(10)2023 May 17.
Artículo en Inglés | MEDLINE | ID: mdl-37240612

RESUMEN

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.

18.
Injury ; 54(7): 110822, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37208254

RESUMEN

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.


Asunto(s)
Fracturas del Fémur , Fijación Intramedular de Fracturas , Estados Unidos/epidemiología , Humanos , Masculino , Anciano , Incidencia , Estudios Transversales , Fijación Intramedular de Fracturas/métodos , Estudios Retrospectivos , Medicare , Fracturas del Fémur/complicaciones , Medición de Riesgo , Resultado del Tratamiento
19.
J Arthroplasty ; 38(9): 1869-1876, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-36966889

RESUMEN

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.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Humanos , Polietileno , Óxido de Aluminio , Aleaciones de Cromo , Cerámica , Falla de Prótesis
20.
J Arthroplasty ; 38(9): 1885-1891, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-36813217

RESUMEN

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.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Prótesis de Cadera , Osteólisis , Humanos , Polietileno , Antioxidantes , Falla de Prótesis , Diseño de Prótesis
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