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1.
Am J Sports Med ; 52(8): 1979-1983, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38828652

RESUMO

BACKGROUND: Synthetic grafts have been used for a number of years in anterior cruciate ligament (ACL) reconstruction surgery. One of the more recent additions to the stable of synthetic ligaments is the Ligament Augmentation and Reconstruction System (LARS) ligament. PURPOSE: To analyze the biomechanics and histology of LARS grafts retrieved due to failure of the device. STUDY DESIGN: Descriptive laboratory study. METHODS: A total of 22 LARS ligament grafts that were explanted from patients were sent for analysis. Five new, unused samples of the standard LARS ACL graft were also analyzed. Biomechanical testing was performed: ultimate tensile force, force versus displacement, and stress versus strain were recorded. Histopathological examination was performed looking for degree of fibrous tissue ingrowth as well as the presence of a foreign body reaction. RESULTS: Of the 22 grafts retrieved, 14 were used for ACL grafts, 1 for a lateral collateral ligament graft, 2 for medial collateral ligament grafts, 4 for gluteal tendon augmentation, and 1 for a supraspinatus augmentation. A severe foreign body reaction was found in 86% of the grafts (18/22) and a mild foreign body reaction in the remaining 14% (4/22). Tissue ingrowth was minimal in the majority of ACL grafts; the other grafts showed moderate tissue ingrowth. Maximal tensile force was significantly higher for the new ACL grafts (mean ± SD, 1667 ± 845 N) compared with the retrieved grafts (897 ± 395 N; P < .05). CONCLUSION: This study demonstrated that the vast majority of retrieved LARS artificial ligaments had a florid foreign body reaction. There was minimal tissue ingrowth in ACL grafts and moderate ingrowth in other grafts. Retrieved grafts had a decreased ultimate tensile force, which increased their risk of rupture. CLINICAL RELEVANCE: Surgeons should be cautious in choosing to use these grafts in reconstructive surgery for patients.


Assuntos
Reconstrução do Ligamento Cruzado Anterior , Ligamento Cruzado Anterior , Humanos , Fenômenos Biomecânicos , Adulto , Ligamento Cruzado Anterior/cirurgia , Masculino , Feminino , Pessoa de Meia-Idade , Resistência à Tração , Adulto Jovem , Reação a Corpo Estranho/etiologia , Próteses e Implantes , Adolescente
2.
Heliyon ; 9(2): e13349, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36816240

RESUMO

A face shield is a secondary personal protective equipment (PPE) for healthcare workers (HCW). Worn with the appropriate face masks/respirators, it provides short term barrier protection against potentially infectious droplet particles. Coronavirus disease 2019 (COVID-19) caused a spike in demand for PPE, leading to a shortage and risking the safety of HCW. Transport restrictions further challenged the existing PPE supply chain which has been reliant on overseas-based manufacturers. Despite the urgency in demand, PPE must be properly tested for functionality and quality. We describe the establishment of local face shields manufacture in Western Australia to ensure adequate PPE for HCW. Ten thousand face shields for general use (standard) and for ear, nose and throat (ENT) specialist use were produced. Materials and design considerations are described, and the face shields were vigorously tested to the relevant Standards to ensure their effectiveness as a protective barrier, including splash and impact resistance. Comparative testing with traditional and other novel face shields was also undertaken. Therapeutic Goods Administration (TGA) licence was obtained to manufacture and supply the face shields as a Class I medical device. The swiftness of process is a credit to collaboration from industry, academia and healthcare.

3.
Hip Int ; 33(1): 28-33, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33832324

RESUMO

BACKGROUND: Although the Pinnacle Acetabular Hip System (DePuy Synthes) has demonstrated excellent survivorship results since it was first introduced in 2003, there have been a growing number of cases indicating that Pinnacle liners may be subject to a higher-than-expected rate of early dissociation failure. Between 2006 and 2020, our Centre received 212 retrieved Pinnacle liners from Western Australian hospitals. Of these, 26 were removed due to liner dissociation. METHODS: To better understand the frequency and cause of this complication we assessed all retrieved Pinnacle acetabular components for type, damage modes and patient demographics. The leverage force required to dissociate Pinnacle liners was also measured and compared with another commonly used acetabular system, the Trident (Stryker Orthopaedics). RESULTS: The estimated minimum incidence of liner dissociation from our data was 0.35%. Characterisation of dissociated Pinnacle cases (n = 26) revealed 73% were female with an average age of 59 compared to all retrieved Pinnacle cases (n = 212) where 58% were female with an average age of 66. Retrieval analysis indicated plastic deformation of the liner into an ovoid shape, signs of impingement on the rim postero-superiorly and shearing of the liner's anti-rotation tabs was common. Mechanical testing indicated that the dissociation strength of Pinnacle cups decreases at approximately 6.6 N/year in situ (p = 0.01). CONCLUSION: The survival rate of Pinnacle acetabular cups is exceptional with only 5% revised at 10 years. However, surgeons should be aware of the clinical symptoms and high-risk demographics when assessing patients with polyethylene Pinnacle liners.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Acetábulo/cirurgia , Artroplastia de Quadril/efeitos adversos , Austrália , Prótese de Quadril/efeitos adversos , Polietileno , Desenho de Prótese , Falha de Prótese , Reoperação
4.
Hip Int ; 33(6): 1072-1078, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36357353

RESUMO

BACKGROUND: Fretting corrosion at modular junctions contributes to arthroplasty failure. Currently, no evidence-based guidelines are available regarding the acceptable level of trunnion corrosion that can occur in vivo. We aimed to examine the relationship between trunnion corrosion and risk of re-revision to assist surgeons with intraoperative decision making. METHOD: Grading by 3 independent examiners of revised and re-revised head components was performed using a modified Goldberg corrosion scale. Samples were separated into low-grade (LG) and high-grade (HG) corrosion. Mechanical testing determined the relationship between corrosion severity and pull-off strength at the head-stem junction. RESULTS: 529 retrieved femoral heads were analysed. A positive association was detected between males and HG corrosion (OR 2.07; 95% CI, 1.45-2.94; p < 0.001). No difference between the survivorship of LG and HG heads was detected (p-value = 0.247). In the re-revised sample, the first implant had a time in situ that was on average 7.97 years longer (95% CI, 5.4-10.6) than that of the subsequent re-revised femoral head. Severe corrosion on the first head was associated with a 37.5 (95% CI, 4.00-1944) fold increase of HG on the subsequent head (p < 0.001). Femoral disassembly force had a positive correlation with stem taper corrosion grade (p = 0.001). CONCLUSIONS: A well-fixed stem with corrosion may remain in situ.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Masculino , Humanos , Cabeça do Fêmur/cirurgia , Artroplastia de Quadril/efeitos adversos , Prótese de Quadril/efeitos adversos , Falha de Prótese , Desenho de Prótese , Corrosão
5.
J Vasc Surg Venous Lymphat Disord ; 10(5): 1095-1100.e3, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35644335

RESUMO

OBJECTIVE: In the present study, we investigated the structural integrity of inferior vena cava (IVC) filters after their retrieval. METHODS: A prospective ex vivo biomechanical analysis was performed of the structural integrity of 100 IVC filters used in a randomized controlled trial to evaluate the effectiveness of prophylactic IVC filters in preventing mortality or symptomatic pulmonary embolism in major trauma patients. RESULTS: Of the 100 included patients, 7 (7%) had required more than one attempt to remove the filter. The median duration of the filter left in situ was 54 days (interquartile range, 17-101 days). During the initial attempt to remove six filters (6%), thrombi were found entrapped and required 4 weeks of systemic anticoagulation therapy before the filters could be removed in a second attempt. A positive correlation was found between the duration of the filter left in situ and the loss in metallic elasticity of the nitinol alloy of the filter struts (Pearson correlation coefficient, 0.232; P = .008). One filter was adherent to the IVC wall and required open surgical removal 227 days after its initial placement. One of the six long struts of the filter had been fractured during the removal process, with evidence of hardening to bending stress in the remaining five struts of the fractured filter compared with the struts of the 25 intact filters. Fibrous endothelial tissue (73%) and thrombi (33%) adherent to the retrieved filters were frequently observed. The presence of adherent fibrous tissue was not significantly related statistically to the duration of the filter left in situ (P = .353) but was more common among the patients who had had a delay in receiving prophylactic anticoagulation therapy (mean difference, 2 days; 95% confidence interval, 0.6-3.3; P = .039). CONCLUSIONS: Metallic fatigue might account for IVC filter strut fractures. Fibrous endothelial tissue adherent to the filters was common, especially for those with a delay in receiving prophylactic anticoagulation therapy.


Assuntos
Embolia Pulmonar , Filtros de Veia Cava , Anticoagulantes , Remoção de Dispositivo/efeitos adversos , Humanos , Estudos Prospectivos , Embolia Pulmonar/prevenção & controle , Estudos Retrospectivos , Resultado do Tratamento , Veia Cava Inferior/cirurgia
6.
J Biomed Mater Res A ; 109(3): 374-384, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32515102

RESUMO

Tuneable, bioactive hydrogels present an attractive option as cell-instructive substrates for tissue regeneration. Properties mimicking the extracellular matrix at the site of injury are sought after, in particular the ability to regulate growth factors that are key to the regeneration process. This study demonstrates the successful formation of hydrogels with heparin functionalities and fibroblast growth factor-2 (FGF-2). Poly(2-hydroxyethyl methacrylate)-heparin hydrogels were capable of retaining FGF-2 by specific binding to heparin and subsequently showed sustained presentation of the growth factor to mesenchymal stromal cells (MSC). Heparin acted as stable anchoring molecules for FGF-2 on the substrate and the synergistic effect of the ensuing heparin-FGF-2 complex was evident in supporting long term cell growth. The presence of heparin during 3D scaffold formation was also found to introduce surface roughness and microporosity to the resulting hydrogels. While FGF-2 has been known to encourage MSC growth and maintain their multilineage potential, other heparin-binding ligands such as bone morphogenetic proteins are potent differentiation stimuli for MSC. Therefore preserving MSC multipotency or a push toward a differentiation pathway may be pursued by the choice of ligand applied to and bound by the heparin functionalities on the current substrate.


Assuntos
Preparações de Ação Retardada/química , Fator 2 de Crescimento de Fibroblastos/administração & dosagem , Heparina/química , Hidrogéis/química , Linhagem Celular , Proliferação de Células/efeitos dos fármacos , Fator 2 de Crescimento de Fibroblastos/farmacologia , Humanos , Células-Tronco Mesenquimais/citologia , Células-Tronco Mesenquimais/efeitos dos fármacos
8.
Bone Joint J ; 101-B(10): 1248-1255, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31564141

RESUMO

AIMS: The aim of this study was to conduct the largest low contact stress (LCS) retrieval study to elucidate the failure mechanisms of the Porocoat and Duofix femoral component. The latter design was voluntarily recalled by the manufacturer. MATERIALS AND METHODS: Uncemented LCS explants were divided into three groups: Duofix, Porocoat, and mixed. Demographics, polyethylene wear, tissue ingrowth, and metallurgical analyses were performed. RESULTS: In 104 implants, a decrease in the odds of loosening and an increase in metallosis and tissue staining in the Duofix group relative to Porocoat group was detected (p = 0.028). There was an increased presence of embedded metallic debris in the Duofix group (p < 0.001). Decreased tissue ingrowth was associated with the Duofix surface (p < 0.001). The attached beads had reduced microhardness, indicative of adverse thermal processing, which resulted in bead shedding, particulate debris, and metallosis. CONCLUSION: Hydroxyapatite coating of the LCS femoral component produced unexpected results and led to its recall. The root cause was likely a combination of retained alumina grit and a reduction in bead microhardness (mechanical strength) resulting in increased particle debris, metallosis, and early revision. The Duofix LCS femoral component was not equivalent to the Porocoat version despite its approval through the Food and Drug Administration (FDA) 510(k) equivalance approval process. Regulation of the introduction of modified existing devices needs to be improved and the Duofix LCS should have been considered to be a new device for which equivalence had not been demonstrated at the point of introduction. Cite this article: Bone Joint J 2019;101-B:1248-1255.


Assuntos
Artroplastia do Joelho/efeitos adversos , Remoção de Dispositivo , Prótese do Joelho/efeitos adversos , Falha de Prótese , Estresse Mecânico , Idoso , Austrália , Intervalos de Confiança , Análise de Falha de Equipamento , Feminino , Humanos , Modelos Logísticos , Masculino , Razão de Chances , Desenho de Prótese
9.
N Engl J Med ; 381(4): 328-337, 2019 07 25.
Artigo em Inglês | MEDLINE | ID: mdl-31259488

RESUMO

BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).


Assuntos
Embolia Pulmonar/prevenção & controle , Filtros de Veia Cava , Ferimentos e Lesões/terapia , Adulto , Angiografia por Tomografia Computadorizada , Humanos , Incidência , Escala de Gravidade do Ferimento , Estimativa de Kaplan-Meier , Perna (Membro)/diagnóstico por imagem , Pulmão/diagnóstico por imagem , Pessoa de Meia-Idade , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/epidemiologia , Embolia Pulmonar/mortalidade , Risco , Falha de Tratamento , Ultrassonografia , Trombose Venosa/diagnóstico por imagem , Ferimentos e Lesões/mortalidade
10.
J Bone Joint Surg Am ; 101(9): 804-811, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-31045668

RESUMO

BACKGROUND: Mechanical failure of intramedullary nails is rare. This investigation was prompted by a series of cases of observed breakage of the recently introduced TFNA Proximal Femoral Nailing System (TFN [Trochanteric Fixation Nail]-Advanced; DePuy Synthes) in our region. Laboratory analysis and case data are presented, in contribution to post-market surveillance. METHODS: Medical and imaging records from the 3 public tertiary orthopaedic trauma hospitals in Western Australia were reviewed. Relevant data of patients in whom breakage of the TFNA implant occurred between 2016 and 2018 were collected and analyzed. Laboratory review of retrieved implants was conducted at the Centre for Implant Technology and Retrieval Analysis (CITRA) in Western Australia. RESULTS: A total of 16 cases of TFNA implant breakage were recorded and analyzed. The predominant OTA/AO fracture classification was 31A3 (12 cases, 75%). The reduction quality was good in 10 cases, acceptable in 4 cases, and poor in 2 cases. The mean time to failure (and standard deviation) was 5.0 ± 2.2 months (range, 2.2 to 9.8 months). The treatment modality for the breakage was revision nailing in 11 cases, arthroplasty in 3, and nonoperative management in 2. All nails broke at the proximal screw aperture, with 1 nail additionally breaking at the distal aperture. Of 8 patients treated with a second TFNA implant for nail breakage, 3 (38%) returned with breakage of the revision implant. Laboratory analysis of the broken nails demonstrated a unique fracture pattern, with a stepped propagation pathway. CONCLUSIONS: This study represents the largest series, to our knowledge, of proximal femoral nail breakages in the published English literature and is the first that we are aware of to involve laboratory analysis of the TFNA implant. Changes to the nail design and/or alloy may have contributed to the observed cases of breakage, and this study will be followed by an evaluation of breakage rates in comparison with those of previous generations of nailing systems. We advise close clinical and radiographic surveillance of patients with unstable hip fracture patterns who undergo osteosynthesis with use of a TFNA implant. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Pinos Ortopédicos/efeitos adversos , Fraturas do Fêmur/cirurgia , Fixação Intramedular de Fraturas/instrumentação , Falha de Prótese/etiologia , Idoso , Idoso de 80 Anos ou mais , Análise de Falha de Equipamento , Feminino , Fraturas do Fêmur/diagnóstico por imagem , Fraturas do Fêmur/etiologia , Fixação Intramedular de Fraturas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Tempo , Austrália Ocidental
11.
Orthop J Sports Med ; 6(12): 2325967118811604, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30547043

RESUMO

BACKGROUND: Artificial ligaments have been developed and used in the treatment of ligamentous injuries since the 1970s. The early generation of artificial ligaments showed promising short-term results but resulted in high rates of rupture and inflammatory reaction in the surrounding tissues. PURPOSE: To determine whether the use of Ligament Augmentation and Reconstruction System (LARS) ligaments is associated with the development of intra-articular foreign body reaction. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: LARS ligaments were explanted from 15 patients under 6 consultant orthopaedic surgeons at 8 surgical centers. Of these, 14 explanted samples were sent for macroscopic and histological analysis, with the 1 remaining sample sent for scanning electron microscopy, to assess for inflammatory change as well as the degree of fibrous tissue ingrowth. RESULTS: We observed a foreign body reaction in 10 of 14 explanted LARS ligaments. Seven samples demonstrated fibrous tissue ingrowth, with 5 producing only focal or incomplete ingrowth. The 2 samples with extensive fibrous coverage were completely free of any foreign body reaction, while all 5 remaining samples with only focal or partial fibrous ingrowth were associated with at least some degree of harmful immune response. CONCLUSION: The LARS ligament is still associated with a clinically significant degree of foreign body reaction despite the LARS Company's efforts to reduce complications through improved design. The development and completion of fibrous tissue ingrowth may work to reduce the occurrence of a foreign body reaction.

12.
J Tissue Eng Regen Med ; 12(2): 341-348, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28488350

RESUMO

Cranioplasty is necessary for patients that have undergone craniectomy following trauma, stroke or other causes of elevated intracranial pressure. This study assessed the effectiveness of treating cranial defects with allogeneic mesenchymal stromal cells (MSC) on a ceramic carrier and polymer scaffold, to produce viable bone and healing of a cranial void. Patients underwent a baseline computed tomography (CT) scan for construct design. Two sets of interlocking moulds were three-dimensional printed to enable shaping of two polymer meshes, which formed the boundaries of the construct corresponding to restoration of the skull interna and externa. In vitro expanded donor MSC were seeded onto ceramic granules in a good manufacturing practices facility. The inner mesh was placed in theatre, followed by the cell-loaded granules, and the outer mesh. Patients were followed-up at 3, 6 and 12 months and cosmesis assessed visually, while bone formation was assessed by CT scans at 1 day, 3 months and 12 months. Manufacture of the construct and surgery was uneventful for all three patients. Initial cosmesis was excellent with no complications. New bone formation was demonstrated by analysis of CT data; however, bone resorption was noted in all 3 cases on the 12-month CT scan. The lack of rigidity of the construct in an environment with continuous pulsatile movement may be preventing the formation of solid bone. It is possible to produce a customized allogeneic MSC construct for cranial reconstruction to replace cranial bone with good cosmesis, using a combination of medical computer modelling, rapid-prototyping and tissue engineering.


Assuntos
Transplante de Células-Tronco Mesenquimais , Células-Tronco Mesenquimais/citologia , Crânio/fisiologia , Adolescente , Adulto , Idoso , Densidade Óssea , Feminino , Humanos , Implantes Experimentais , Masculino , Pessoa de Meia-Idade , Engenharia Tecidual , Tomografia Computadorizada por Raios X , Transplante Homólogo , Adulto Jovem
13.
JB JS Open Access ; 3(4): e0019, 2018 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-30882053

RESUMO

BACKGROUND: Corrosion has been documented in modular knee implants, but it has not been related to negative patient outcomes. We performed an observational retrieval investigation of 13 Stryker Triathlon TS modular knee implants, 3 of which were revised because of osteolysis and adverse local tissue reactions secondary to fretting corrosion at the modular junctions. METHODS: Modular surfaces were examined for the presence and severity of corrosion, and factors that may influence the development of corrosion were investigated. Scanning electron microscopy and energy-dispersive x-ray spectroscopy were performed to evaluate implants with severe corrosion, and tissue samples were sent for histopathological analysis. RESULTS: Mild to severe corrosion was present in association with 62% of modular tibial components and 75% of modular femoral components. Although tibial corrosion was less prevalent than femoral corrosion, it occurred earlier and with greater severity. Scanning electron microscopy and energy-dispersive x-ray spectroscopy demonstrated the appearances of fretting and corrosion of the modular junctions. Histopathological analysis of specimens from the 3 patients with adverse local tissue reactions demonstrated severe reactions to metal debris, including 1 reaction that was consistent with an aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL). CONCLUSIONS: To our knowledge, ALVAL and pseudotumors have not previously been reported secondary to corrosion of modular knee replacements. The threaded taper design and the release of cobalt-chromium ions and/or debris are implicated in the occurrence of the adverse local tissue reactions, osteolysis, and soft-tissue damage that we observed in our investigation. Clinicians should be aware of this possible complication associated with modular knee implants. CLINICAL RELEVANCE: This article should raise clinician awareness of adverse local tissue reactions secondary to corrosion, potentially resulting in earlier recognition of this complication.

14.
BMJ Open ; 7(7): e016747, 2017 07 12.
Artigo em Inglês | MEDLINE | ID: mdl-28706106

RESUMO

INTRODUCTION: Retrievable inferior vena cava (IVC) filters have been increasingly used in patients with major trauma who have contraindications to anticoagulant prophylaxis as a primary prophylactic measure against venous thromboembolism (VTE). The benefits, risks and cost-effectiveness of such strategy are uncertain. METHODS AND ANALYSIS: Patients with major trauma, defined by an estimated Injury Severity Score >15, who have contraindications to anticoagulant VTE prophylaxis within 72 hours of hospitalisation to the study centre will be eligible for this randomised multicentre controlled trial. After obtaining consent from patients, or the persons responsible for the patients, study patients are randomly allocated to either control or IVC filter, within 72 hours of trauma admission, in a 1:1 ratio by permuted blocks stratified by study centre. The primary outcomes are (1) the composite endpoint of (A) pulmonary embolism (PE) as demonstrated by CT pulmonary angiography, high probability ventilation/perfusion scan, transoesophageal echocardiography (by showing clots within pulmonary arterial trunk), pulmonary angiography or postmortem examination during the same hospitalisation or 90-day after trauma whichever is earlier and (B) hospital mortality; and (2) the total cost of treatment including the costs of an IVC filter, total number of CT and ultrasound scans required, length of intensive care unit and hospital stay, procedures and drugs required to treat PE or complications related to the IVC filters. The study started in June 2015 and the final enrolment target is 240 patients. No interim analysis is planned; incidence of fatal PE is used as safety stopping rule for the trial. ETHICS AND DISSEMINATION: Ethics approval was obtained in all four participating centres in Australia. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ACTRN12614000963628; Pre-results.


Assuntos
Filtros de Veia Cava , Tromboembolia Venosa/prevenção & controle , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Medição de Risco , Tromboembolia Venosa/etiologia , Ferimentos e Lesões/complicações
15.
J Arthroplasty ; 31(3): 727-34, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26723860

RESUMO

BACKGROUND: Many exchangeable neck hip systems have been withdrawn because of fretting corrosion at the neck/stem coupling. METHOD: Our prospective randomized study evaluating stem stability (Roentgen stereophotogrammetric analysis, dual-energy x-ray absorptiometry) and clinical outcomes between the K2/Apex hip systems was ceased early because of a withdrawal of the stems which had an unfavorably high early revision rate reported in the Australian Orthopaedic Association National Joint Registry (9.3% at 3 years). RESULTS: At 2 years, there are no clinical differences between the stems. Roentgen stereophotogrammetric analysis has identified a high proportion of potentially concerning subsidence and retroversion in both groups, more marked in the K2 stem, although mostly in asymptomatic patients. Dual-energy x-ray absorptiometry has shown similar bone density around the stems. Retrieval analysis of 3 study patients showed fretting corrosion of the antirotation pin and aseptic lymphocyte-dominated vasculitis-associated lesion, with no relationship to bearing type or size. Analysis of 7 further nonstudy K2/Apex stems confirmed similar corrosion. CONCLUSION: This study shows potentially concerning subsidence of both stems and is the first to describe corrosion at the neck-stem interface and a relationship to metal-related pathology.


Assuntos
Artroplastia de Quadril/instrumentação , Prótese de Quadril/efeitos adversos , Falha de Prótese/etiologia , Absorciometria de Fóton , Austrália , Corrosão , Humanos , Metais/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Análise Radioestereométrica , Reoperação
16.
J Orthop ; 12(4): 266-71, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26566331

RESUMO

We report a case of metallosis following a shoulder hemiarthroplasty with a humeral component resurfacing shoulder replacement.

17.
J Arthroplasty ; 30(10): 1842-6, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25971535

RESUMO

Since the first use of ultra-high-molecular-weight polyethylene as a bearing material, research and development efforts have sought to improve wear resistance, increase longevity and lessen the potential for debris mediated adverse tissue responses. A series of second generation sequentially cross-linked and annealed tibial bearings were analysed after several bearings sent for routine retrieval analysis showed oxidative degradation including subsurface whitening, cracking and gross material loss. Evaluation incorporated visual and white banding assessment, mechanical testing and spectroscopy analysis. Whilst visual observation and white banding assessment confirmed oxidative changes, a decrease in mechanical properties and increasing ketone oxidation index as a function of time in vivo suggest time dependent oxidative degradation. Clinically relevant degradation of the sequentially cross-linked and annealed tibial bearings was observed.


Assuntos
Prótese de Quadril , Polietilenos/química , Tíbia/cirurgia , Idoso , Reagentes de Ligações Cruzadas/química , Feminino , Humanos , Masculino , Teste de Materiais , Pessoa de Meia-Idade , Oxigênio/química , Polímeros/química , Espectroscopia de Infravermelho com Transformada de Fourier , Estresse Mecânico
18.
JBJS Case Connect ; 5(4): e92, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-29252798

RESUMO

CASE: We present a case of systemic cobalt toxicity secondary to third-body wear of a cobalt-chromium (CoCr) femoral head following revision of a fractured ceramic bearing. Removal of the CoCr head was followed by resolution of much of the systemic symptoms. CONCLUSION: This case supports previous reports of cobalt toxicity secondary to catastrophic third-body wear of a CoCr femoral head following a fractured ceramic bearing. It also demonstrates the potential reversibility of many systemic sequelae associated with cobalt toxicity. To our knowledge, this case represents the highest documented blood cobalt level (45,840 nmol/L).

19.
BMJ Case Rep ; 20142014 Jun 23.
Artigo em Inglês | MEDLINE | ID: mdl-24957586

RESUMO

Before the widespread use of silicone implants various foreign substances were injected directly into the breasts. The nature of these materials sometimes remains unknown and can cause various complications requiring surgical intervention. Preoperative diagnostic imaging can help characterise the type and distribution of the injected material, thereby assisting in making decisions regarding treatment. We report a case of breast augmentation with an unknown substance, aiming to highlight some imaging characteristics of different breast augmentation substances.


Assuntos
Resinas Acrílicas , Mama/patologia , Injeções , Mamoplastia/métodos , China , Feminino , Humanos , Imageamento por Ressonância Magnética , Mamografia , Pessoa de Meia-Idade , Ressonância Magnética Nuclear Biomolecular , Ultrassonografia Mamária
20.
J Arthroplasty ; 29(5): 1043-51, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24360790

RESUMO

Bone ingrowth into uncemented acetabular components requires intimate cup-bone contact and rigid fixation, which can be difficult to achieve in revision hip arthroplasty. This study compares polyaxial compression locking screws with non-locked and cancellous screw constructs for acetabular cup fixation. An acetabular cup modified with screw holes to provide both compression and angular stability was implanted into a bone substitute. Coronal lever out, axial torsion and push-out tests were performed with an Instron testing machine, measuring load versus displacement. Polyaxial locking compression screws significantly improved construct stiffness compared with non-locked or cancellous screws. This increased construct stiffness will likely reduce interfacial micromotion. Further research is required to determine whether this will improve bone ingrowth in vivo and reduce cup failure.


Assuntos
Acetábulo/cirurgia , Artroplastia de Quadril , Parafusos Ósseos , Prótese de Quadril , Desenho de Prótese , Acetábulo/fisiopatologia , Fenômenos Biomecânicos , Substitutos Ósseos , Osseointegração
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