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1.
BMC Musculoskelet Disord ; 22(1): 781, 2021 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-34511090

RESUMO

BACKGROUND: The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the twenty-first century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions. The purpose was to compare Harris Hip Score and SF-36 at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM hip resurfacing (MoM-HR). METHODS: The study was conducted between November 2006 to January 2012 in a tertiary health care center in Denmark. Patients with primary or secondary osteoarthritis were randomly assigned to receive a Magnum (MoM-LDH-THA) or a Recap (MoM-HR) prosthesis. Randomization was computer generated and allocation was concealed in an opaque envelope. Neither patients nor care provider were blinded. Primary outcome was Harris Hip Score at 5-years follow up. RESULTS: Seventy-five were included and allocated to the MoM-LDH-THA (n = 39) and MoM-HR (n = 36) group. The study was prematurely stopped due to numerous reports of adverse events in patients with MoM hip replacements. Thirty-three in the MoM-LDH-THA and 25 in the MoM-HR group were available for primary outcome analysis. Median Harris Hip Score was 100 (IQR: 98-100) for MoM-LDH-THA and 100 (IQR: 93-100) for MoM-HR (p = 0.486). SF-36 score was high in both groups with no significant difference between groups. CONCLUSION: Harris Hip Score and SF-36 score was excellent in both groups with no significant difference at 5-years follow up. Our findings suggest that there is no clinical important difference between the two prostheses implanted 5 years after implantation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04585022 , Registered 23 September 2020 - Retrospectively registered. This study was not prospectively registered in a clinical trial database since it was not an entirely implemented standard procedure in the international orthopedic society when the study was planned.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Próteses Articulares Metal-Metal , Artroplastia de Quadril/efeitos adversos , Cromo , Cobalto/efeitos adversos , Seguimentos , Prótese de Quadril/efeitos adversos , Humanos , Próteses Articulares Metal-Metal/efeitos adversos , Desenho de Prótese , Falha de Prótese , Reoperação
2.
J Orthop Surg Res ; 16(1): 35, 2021 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-33422084

RESUMO

BACKGROUND: Whilst bony fixation of hip replacement has stable solutions, there remains controversy over which bearing best optimizes longevity and function. Ceramic-on-ceramic (CoC) bearing combinations are associated with lower risk of revision due to aseptic loosening and dislocation. Evidence for long-term functional outcomes of modern, 4th generation CoC bearings is limited. The aim of this study was to analyze outcomes and complications of the R3™ Acetabular System (Smith & Nephew, Inc., Cordova, TN, USA) in combination with BIOLOX® Delta ceramic femoral head in patients undergoing primary total hip arthroplasty (THA). METHODS: Between June 2009 and May 2011, 175 patients (178 hips) were enrolled into a prospective, study at 6 sites in Europe and prospectively followed-up at 3 months and 1, 3, 5, and 7 years postoperative. RESULTS: Total WOMAC score improved from 63 (range, 22-91) preoperative to 8 (range, 0-8) at 1-year follow-up and remained unchanged at 7-year follow-up. Modified Harris hip score improved from 45 (range, 10-87) preoperative to 83 (range, 25-100) at 3 months, 91 (range, 42-100) at 1 year, and 92 (range, 46, 100) at 7 years. UCLA Activity Rating Scale score improved from 3.3 (range, 1-8) preoperative to 6.2 (range, 2-8) at 1 year; it marginally declined to 5.8 (range, 3-8) at 7-year follow-up. There were 4 trochanteric fractures and 5 patients died of unrelated reasons. Three hips were revised (2 periprosthetic fractures and 1 subluxation). The 7-year cumulative survival rate was 98.3%. CONCLUSION: Clinical and functional improvements of THA with CoC bearing are maintained at 7 years postoperative. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT03566082 , Registered 10 January 2018-retrospectively registered.


Assuntos
Artroplastia de Quadril/métodos , Cerâmica , Prótese de Quadril , Desenho de Prótese , Acetábulo , Adolescente , Adulto , Idoso , Feminino , Cabeça do Fêmur , Seguimentos , Articulação do Quadril/cirurgia , Humanos , Artropatias/cirurgia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Falha de Prótese , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
3.
Geriatr Gerontol Int ; 18(1): 138-145, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28858422

RESUMO

AIM: To develop and examine the psychometric properties, including responsiveness and interrater reliability, of a new outcome measure for the evaluation of basic mobility activities after a major lower extremity amputation - The Basic Amputee Mobility Score (BAMS). METHODS: The four following essential activities were chosen through consensus meetings with experienced amputee physiotherapists: (i) supine in bed to sitting on the edge of the bed; (ii) bed to wheelchair transfer; (iii) indoor wheelchair mobility; and (iv) get up from a wheelchair to standing on the non-amputated leg. Each activity is scored from 0 to 2 (0 = not able to; 1 = able to with assistance/guiding; and 2 = independent), and cumulated to a 1-day BAMS score of 0-8. Validity and responsiveness were established in 106 consecutive in-hospital patients with a major dysvascular lower extremity amputation, while reliability and agreement were examined in an additional sample of 30 patients. RESULTS: The 30-day mortality risk was reduced by 88% (HR = 0.12, 95% CI 0.02-0.68) for those out of bed (BAMS ≥2 points) at the first physiotherapy assessment, while BAMS scores improved between the first and the discharge assessment, with a standardized response mean of 1.3. Reliability assessments resulted in a weighted Kappa value of 0.98, a standard error of measurement of 0.32 and a minimal detectable change of 0.89 points. No systematic between-rater bias was seen (P = 0.3). CONCLUSIONS: The BAMS was feasible in all patients, and showed a large responsiveness, excellent interrater reliability and with a change of 1 point indicating a real change in performances. Geriatr Gerontol Int 2018; 18: 138-145.


Assuntos
Amputados/psicologia , Limitação da Mobilidade , Inquéritos e Questionários , Humanos , Extremidade Inferior , Psicometria , Reprodutibilidade dos Testes
4.
Diagn Microbiol Infect Dis ; 86(3): 316-321, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27567284

RESUMO

The impact of antibiotic prophylaxis on fecal carriage of ESBL-/AmpC-/carbapenemase-producing Enterobacteriaceae (CPE) was investigated. Patients admitted for elective surgery or diagnostic procedure in a Department of Surgical Gastroenterology (SG) (n= 450) and Orthopedic Surgery (OS) (n= 300) provided a fecal swab at admission and responded to a questionnaire on possible exposures. SG patients received gentamicin/penicillin G (±metronidazole); OS patients received cefuroxime. Two days after surgery a second swab was taken. From SG patients, 6% of first swabs and 9% of second swabs were positive for ESBL-/AmpC-producers. A similar carriage rate was observed in OS patients (6% and 8%, respectively). No CPE were detected. Escherichia coli was the predominant species and blaCTX-M-15 (29% and 22%) and blaCTX-M-14 (11% and 17%) were the most prevalent ESBL genotypes among SG and OS patients. Two different prophylactic antibiotic regimens had no impact on carriage rates. Previous hospitalization and antimicrobial treatment were associated with carriage for SG patients.


Assuntos
Antibioticoprofilaxia , Portador Sadio/microbiologia , Infecções por Enterobacteriaceae/microbiologia , Enterobacteriaceae/enzimologia , Fezes/microbiologia , Cuidados Pré-Operatórios , beta-Lactamases/análise , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Dinamarca , Enterobacteriaceae/isolamento & purificação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
5.
Acta Orthop ; 87(3): 306-11, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27088484

RESUMO

Background and purpose - Historically, high 30-day and 1-year mortality post-amputation rates (> 30% and 50%, respectively) have been reported in patients with a transtibial or higher non-traumatic lower extremity amputation (LEA). We evaluated whether allocating experienced staff and implementing an enhanced, multidisciplinary recovery program would reduce the mortality rates. We also determined factors that influenced mortality rates. Patients and methods - 129 patients with a LEA were consecutively included over a 2-year period, and followed after admission to an acute orthopedic ward. Mortality was compared with historical and concurrent national controls in Denmark. Results - The 30-day and 1-year mortality rates were 16% and 37%, respectively, in the intervention group, as compared to 35% and 59% in the historical control group treated in the same orthopedic ward. Cox proportional harzards models adjusted for age, sex, residential and health status, the disease that caused the amputation, and the index amputation level showed that 30-day and 1-year mortality risk was reduced by 52% (HR =0.48, 95% CI: 0.25-0.91) and by 46% (HR =0.54, 95% CI: 0.35-0.86), respectively, in the intervention group. The risk of death was increased for patients living in a nursing home, for patients with a bilateral LEA, and for patients with low health status. Interpretation - With similarly frail patient groups and instituting an enhanced program for patients after LEA, the risks of death by 30 days and by 1 year after LEA were markedly reduced after allocating staff with expertise.


Assuntos
Amputação Cirúrgica , Extremidade Inferior , Dinamarca , Humanos , Fatores de Risco
6.
J Arthroplasty ; 31(4): 835-41, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26706838

RESUMO

BACKGROUND: Persistent acetabular dysplasia (AD) after periacetabular osteotomy has been hypothesized to increase the risk for malpositioning of the acetabular component. In this study, we investigate whether AD is an independent risk factor for cup malpositioning during primary total hip arthroplasty (THA). METHODS: Patient demographics, surgical approach, presence of AD assessed using the lateral center-edge angle, and acetabular cup positioning determined using Martell Hip Analysis Suite were investigated in 836 primary THA patients enrolled in a prospective multicenter study. RESULTS: We found that presence of AD, defined as the lateral center-edge angle of <25°, is an independent risk factor for malpositioning of the acetabular component during primary THA. Surgical approach other than direct anterior was also independently associated with malpositioned cups. CONCLUSIONS: Surgeons should therefore take special care during placement of the acetabular component in patients with AD.


Assuntos
Acetábulo/cirurgia , Artroplastia de Quadril/métodos , Luxação do Quadril/cirurgia , Adulto , Idoso , Artroplastia de Quadril/efeitos adversos , Feminino , Prótese de Quadril , Humanos , Masculino , Pessoa de Meia-Idade , Osteotomia , Estudos Prospectivos , Fatores de Risco
7.
Hip Int ; 26(1): 97-103, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26692248

RESUMO

PURPOSE: Preclinical studies of vitamin E diffused highly cross-linked polyethylene (E-XLPE) has shown enhanced mechanical properties with less wear. The purpose of our study was to document the early clinical outcome of E-XLPE to ensure, for the safety of patients, that there are no unforeseen early adverse events from using this new biomaterial. METHODS: The enrolled patients (n = 977) have received either a porous titanium coated or porous plasma sprayed acetabular shell with either a E-XLPE liner or a medium cross-linked (AXL) liner. At each follow-up 5 patient-reported outcome measures (PROMs) were completed: Harris Hip Score, Case Mix Indicator, UCLA Activity Score, SF-36, and EQ-5D. Radiographs were measured for cup and stem position, as well as femoral head penetration into the liner (wear). Postoperative complications and revisions were collected. RESULTS: At 3 years follow-up, there were 13 revisions due to: 4 periprosthetic fractures; 1 sepsis; 6 instabilities; and 2 implant mismatches at surgery. Wear of the hip implant, calculated by software analysis of pelvis x-rays, from the postoperative interval to 3 years showed a liner penetration rate of 0.027 mm/year for AXL and 0.005 mm/year for E-XLPE with no significant difference between the 2 (p = 0.24). Improvement was seen in all PROMs from the preoperative interval to 3 years after surgery (p<0.0001). CONCLUSIONS: Early follow-up of the E-XLPE and AXL liners show low penetration. PROMs indicate improvement after total hip arthroplasty in functionality and quality of life across the centers. We have not observed any early in vivo adverse effects from diffusing the liners with vitamin E. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00545285.


Assuntos
Antioxidantes/administração & dosagem , Artroplastia de Quadril/instrumentação , Prótese de Quadril , Osteoartrite do Quadril/cirurgia , Polietileno , Vitamina E/administração & dosagem , Adulto , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
8.
Dan Med J ; 62(12): A5172, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26621398

RESUMO

INTRODUCTION: The successful outcome of a major amputation depends on several factors, including stump wound healing. The purpose of this study was to examine the criteria upon which the index amputation was based and to identify factors associated with early amputation failure after major non-traumatic lower-extremity amputation. METHODS: We studied a consecutive one-year series of 36 men and 34 women with a median (25-75% quartiles) age of 72 (63-83) years who were treated in an acute orthopaedic ward; 44 below-knee and 26 above-knee amputees of whom 47 had an American Society of Anesthesiologists rating above two. Patient characteristics and other factors potentially influencing early amputation failure within 30 days were evaluated. RESULTS: Eleven patients died (16%) and 11 (16%) had a re-amputation at a higher level, whereas four (6%) had a major revision at the same level within 30 days. Amputations were performed by a house officer (n = 29), a specialist registrar (n = 27) or a consultant (n = 14). A total of 28 surgeons performed the included operations. Neither a preoperative skin perfusion test (only measured for 25 patients), nor any of the many other factors evaluated predicted early amputation failure. Patients with one or more failures stayed in the ward for a median of 45 (33-57) days versus 20 (14-25) days for those without failures. CONCLUSIONS: The rate of short-term amputation failures was high, and no clear explanation for this was established. A pre-amputation algorithm to support the right choice of amputation level is needed. FUNDING: none. TRIAL REGISTRATION: This trial was registered with the Danish Data Protection Agency (R. no. 01975 HVH-2012-053).


Assuntos
Amputação Cirúrgica/efeitos adversos , Reoperação/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica/mortalidade , Feminino , Humanos , Tempo de Internação , Extremidade Inferior/cirurgia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Falha de Tratamento , Cicatrização
9.
Clin Orthop Relat Res ; 473(11): 3391-8, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25762017

RESUMO

BACKGROUND: Worldwide use of cementless fixation for total hip arthroplasty (THA) is on the rise despite some evidence from the world's registries suggesting inferior survivorship compared with cemented techniques. The patterns of bone loss associated with failed cementless and cemented THAs may prejudice the results of future revision procedures; however, this has not been documented. QUESTIONS/PURPOSES: The purpose of this study was to compare (1) the risk for rerevision of first revision THA; (2) the patterns of femoral bone loss at the time of first revision of primary THA; (3) the reasons for first revision of primary THA; and (4) the time to first revision of primary THA between primary cementless and cemented femoral components. METHODS: Primary THAs with cemented (n = 1791) and uncemented (n = 805) femoral components that subsequently sustained first revision of the femoral component were identified from the Danish Hip Arthroplasty Registry (DHR). As of 2012, 120,988 primary THAs and 19,282 revisions were registered in the DHR with completeness of 97% and 90% for primary and revision THA, respectively. Median followup for revisions of primary THA with cemented and cementless femoral component was 4 years (range, 0-17 years) and 2 years (range, 0-16 years), respectively. Survival of first revision THA, with second revision of the femur as outcome, was evaluated using hazard ratios (HRs) with 95% confidence interval (CI) adjusting for potential confounding. All patient- and surgery-related data are collected from Danish medical databases. Recording of bone defects in the DHR is based on surgeons' intraoperative findings. RESULTS: With the numbers studied, we found no differences in the risk of second revision between the overall cohort between cementless and cemented techniques (HR, 1.32; 95% CI, 0.97-1.80; p = 0.076); however, a second revision for any reason was more likely in patients < 70 years old in whom the index arthroplasty was performed using a cementless technique (HR, 1.48; 95% CI, 1.01-2.17; p = 0.046). Increasingly severe femoral bone defects of type II (30% [532 of 1791] versus 13% [104 of 805]; p < 0.001) type III (11% [200 of 1791] versus 2% [12 of 805]; p < 0.001) and type IV (1% [26 of 1791] versus 0.4% [three of 805]; p = 0.016) were more frequent at revisions of cemented femoral components compared with cementless femoral components. Indications for first revision differed between primary cemented and uncemented femoral components, because a larger proportion of cemented femoral components was revised as a result of aseptic loosening compared with cementless femoral components (74% [1329 of 1791] versus 25% [197 of 805]; p < 0.001), whereas a larger proportion of cementless femoral components was revised as a result of a fracture compared with cemented femoral components (46% [371 of 805] versus 10% [168 of 1791]; p < 0.001). Failure before 5 years was more likely in cementless femoral components than cemented femoral components (91% [733 of 805] versus 44% [749 of 1791], p < 0.001). CONCLUSIONS: We found no differences in the risk of second revision in the overall cohort between cementless and cemented techniques; however, we observed an increased risk for rerevision THA performed on patients < 70 years whose index THAs were performed using cementless components when looking at all causes for revision, even after adjusting for the most likely confounding factors. Our data suggest that increased use of cementless fixation in primary THA may lead to inferior survivorship of first revision THA. LEVEL OF EVIDENCE: Level III, therapeutic study.


Assuntos
Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/instrumentação , Cimentos Ósseos/uso terapêutico , Fêmur/cirurgia , Articulação do Quadril/cirurgia , Prótese de Quadril , Complicações Pós-Operatórias/cirurgia , Idoso , Cimentos Ósseos/efeitos adversos , Dinamarca , Feminino , Fêmur/fisiopatologia , Articulação do Quadril/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico , Modelos de Riscos Proporcionais , Desenho de Prótese , Falha de Prótese , Sistema de Registros , Reoperação , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
10.
Acta Orthop ; 85(6): 548-55, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25285615

RESUMO

BACKGROUND AND PURPOSE: Traditions are passed on from experienced surgeons to younger fellows and become "the right way to do it". Traditions associated with arthroplasty surgery may, however, not be evidence-based and may be potentially deleterious to both patients and society, increasing morbidity and mortality, slowing early functional recovery, and increasing cost. METHODS: We identified selected traditions and performed a literature search using relevant search criteria (June 2014). We present a narrative review grading the studies according to evidence, and we suggest some lines of future research. RESULTS: We present traditions and evaluate them against the published evidence. Preoperative removal of hair, urine testing for bacteria, use of plastic adhesive drapes intraoperatively, and prewarming of the operation room should be abandoned-as should use of a tourniquet, a space suit, a urinary catheter, and closure of the knee in extension. The safety and efficacy of tranexamic acid is supported by meta-analyses. Postoperatively, there is no evidence to support postponement of showering or postponement of changing of dressings to after 48 h. There is no evidence to recommend routine dental antibiotic prophylaxis, continuous passive motion (CPM), the use of compression stockings, cooling for pain control or reduction of swelling, flexion of at least 90 degrees as a discharge criterion following TKA, or having restrictions after THA. We present evidence supporting the use of NSAIDs, early mobilization, allowing early travel, and a low hemoglobin trigger for transfusion. INTERPRETATION: Revision of traditions and myths surrounding hip and knee arthroplasty towards more contemporary evidence-based principles can be expected to improve early functional recovery, thus reducing morbidity, mortality, and costs.


Assuntos
Artroplastia de Quadril/normas , Artroplastia do Joelho/normas , Atitude do Pessoal de Saúde , Medicina Baseada em Evidências , Humanos , Guias de Prática Clínica como Assunto
11.
J Arthroplasty ; 29(11): 2078-83, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25129452

RESUMO

Precise indications for THA remain unclear and regional differences might exist in selecting patients for surgery. In this study we investigate radiological OA grade and self-reported quality of life in 909 patients undergoing THA in 16 centers across US and Europe. Patients in US were younger and had higher BMI. More patients with mild Tönnis OA grade underwent surgery in the US compared to Europe. Patients in the US had significantly higher pain VAS and significantly lower SF-36 Physical, while having significantly higher EQ-VAS scores preoperatively. Patient demographics and disease severity according to radiological OA grade and self-reported survey scores vary between the United States and Europe. This knowledge can be used in the interpretation of US and European based studies on outcome following THA.


Assuntos
Artroplastia de Quadril , Osteoartrite do Quadril/diagnóstico por imagem , Osteoartrite do Quadril/cirurgia , Idoso , Europa (Continente) , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Radiografia , Resultado do Tratamento , Estados Unidos
12.
J Arthroplasty ; 29(2): 443-7, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23891061

RESUMO

Radial impaction grafting (RIG) potentially improves the durability and reliability of cementing the femoral components in revision total hip arthroplasty (THA). In this multicenter, prospective study, 88 revision THAs (87 patients) with RIG technique were performed. The average follow-up time was 7.0 years (range, 5.0-10.2). There were 14 femur fractures: 2 intraoperative, 5 within 3 months after surgery, and 7 later in the postoperative stage (range, 5-84 months). Sixteen patients were lost to follow-up and 20 died without stem re-revision. None of the patients have been re-revised for any reason during follow-up. Age was observed to be a significant factor for determining fracture risk. In conclusion, RIG can be considered a reliable surgical technique, especially for younger patients.


Assuntos
Artroplastia de Quadril/efeitos adversos , Transplante Ósseo/métodos , Fraturas do Fêmur/cirurgia , Articulação do Quadril/cirurgia , Fraturas Periprotéticas/cirurgia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Cimentação , Feminino , Fraturas do Fêmur/etiologia , Seguimentos , Prótese de Quadril , Humanos , Masculino , Pessoa de Meia-Idade , Fraturas Periprotéticas/etiologia , Estudos Prospectivos , Reoperação , Fatores de Risco
13.
Clin Drug Investig ; 33(9): 607-19, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23912473

RESUMO

BACKGROUND: Tapentadol prolonged release (PR; 100-250 mg twice daily) has been efficacious and well tolerated for managing moderate-to-severe, chronic osteoarthritis hip or knee pain in phase 3 studies with washout of previous analgesic treatment. OBJECTIVE: The objective of this study was to evaluate the effectiveness and tolerability of tapentadol PR (50-250 mg twice daily) after direct rotation from World Health Organization (WHO) step III opioids in patients with severe osteoarthritis knee pain who previously responded to WHO step III therapy but showed poor tolerability. METHODS: This open-label, phase 3b study (NCT00982280) was conducted from October 2009 through June 2010 (prematurely terminated due to slow recruitment and study drug shortages) in clinical care settings in Europe and Australia. The study population included patients with severe, chronic osteoarthritis knee pain who had taken WHO step III opioids daily for ≥2 weeks before screening, responded to therapy (average pain intensity [11-point numerical rating scale-3 (NRS-3)] ≤5 at screening), and reported opioid-related adverse effects as their reason for changing analgesics. Patients switched directly from WHO step III therapy to tapentadol. Patients received oral tapentadol PR (50-250 mg twice daily) during 5-week titration and 7-week maintenance periods. Oral tapentadol immediate release (IR) was permitted (≤twice/day, ≥4 h apart) for acute pain episodes due to index pain or withdrawal symptoms following discontinuation of previous opioids (combined dose of tapentadol [PR and IR] ≤500 mg/day). This study was planned to evaluate conversion to tapentadol PR, based on responder rate 1 (percentage of patients with same/less pain [NRS-3] versus Week -1) at Week 6 (primary endpoint), adverse events (AEs), and discontinuation rates. Equianalgesic ratios were calculated for tapentadol prior to WHO step III opioids (PR and PR plus IR formulations). RESULTS: Of 82 patients enrolled, 63 received study medication. In the per-protocol population, responder rate 1 at Week 6 (last observation carried forward) was 94.3 % (50/53; P < 0.0001 vs. the null hypothesis rate [<60 %]). Mean (standard deviation) pain intensity scores were 4.7 (0.66) at baseline, 2.5 (1.46) at Week 6, and 1.8 (1.41) at Week 12 in the main analysis population (change from baseline at Weeks 6 and 12, P < 0.0001). Tapentadol to transdermal buprenorphine equianalgesic ratios (PR [n = 48], 262.9:1; PR plus IR [n = 48], 281.1:1) and tapentadol to oral oxycodone equianalgesic ratios (PR [n = 4], 4.3:1; PR plus IR [n = 6], 4.6:1) were calculated for the main analysis population. In the safety population, prevalence of AEs reported as associated with prior opioids at Week -1 (reasons for rotation) and related to tapentadol treatment at Week 12 decreased over time; the most common were nausea (46.0 vs. 24.1 %) and constipation (31.7 vs. 7.4 %). Overall, 14.3 % of patients discontinued the study early; reasons included AEs (9.5 %), lack of efficacy (3.2 %), and withdrawal of consent (1.6 %). CONCLUSIONS: Significant improvements in effectiveness were observed for tapentadol PR (50-250 mg twice daily) versus WHO step III opioids in patients with severe, chronic osteoarthritis knee pain who previously responded to WHO step III therapy. Equianalgesic ratios were calculated for tapentadol to transdermal buprenorphine and oral oxycodone and were in line with observations from previous phase 3 studies.


Assuntos
Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Fenóis/uso terapêutico , Receptores Opioides mu/agonistas , Idoso , Preparações de Ação Retardada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/tratamento farmacológico , Fenóis/efeitos adversos , Tapentadol
14.
Dan Med J ; 59(10): A4515, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23158892

RESUMO

INTRODUCTION: Immediate weight-bearing following osteosynthesis of proximal tibial fractures is traditionally not allowed due to fear of articular fracture collapse. Anatomically shaped locking plates with sub-articular screws could improve stability and allow greater loading forces. The purpose of this study was to investigate if immediate weight-bearing can be allowed following locking plate osteosynthesis of proximal tibial fractures. MATERIAL AND METHODS: Locking plate osteosynthesis of partial articular proximal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen type 41B) operated from November 2007 to September 2009 at Hvidovre Hospital were included retrospectively (n = 32). Complications, reoperations and radiographic outcome at 6-8 week of follow-up were assessed. Twenty patients were not allowed to bear weight the first 6-8 weeks, whereas twelve were allowed immediate postoperative weight-bearing. RESULTS: The use of bone allograft, the number of screws inserted and the application of postoperative articular mobilizing brace were comparable between the two groups (p = 0.08). Persisting depressions of the articular surface ranged from 0 to 5 mm postoperatively with no difference between the groups (p = 0.36). At 6-8 weeks postoperatively, no changes in radiographic configuration of the fracture site were observed in either group. CONCLUSION: This retrospective study suggests that immediate weight-bearing following locking plate osteosynthesis of partial articular proximal tibial fractures may be allowed. Future, larger prospective randomised studies are needed. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.


Assuntos
Placas Ósseas , Parafusos Ósseos , Fixação Interna de Fraturas/instrumentação , Consolidação da Fratura/fisiologia , Fraturas da Tíbia/cirurgia , Suporte de Carga/fisiologia , Adulto , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Estudos Retrospectivos , Fraturas da Tíbia/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
15.
Open Orthop J ; 6: 366-70, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22930667

RESUMO

The aim of the present study was to determine the frequency of adverse reaction to metal on metal total hip arthroplasty using a M2a-38 articulation and a Magnum articulation, (Biomet Warsaw, Indiana).All patients who had received a Metal on Metal bearing prosthesis, in two centres in Copenhagen, were asked to complete a questionnaire about groin pain. Patients with self-reported groin pain, 68/314, underwent a physical examination and had Co and Cr ion levels measured in full blood samples. Fifty patients also had a CT scan performed.The present study found one patient with bilateral arthroplasty, who had an adverse reaction on one side. In addition the study showed that females had higher values of Co and Cr, and that younger patient reported groin pain more often.The conclusion of this study is that the number of adverse reactions is low, despite the time of observation being relatively short, no high frequency of adverse reactions to this prosthesis is expected.

16.
Interact Cardiovasc Thorac Surg ; 14(5): 543-7, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22298857

RESUMO

The aim of this retrospective study was to evaluate factors potentially influencing short- and long-term mortality in patients who had a non-traumatic lower limb amputation in a university hospital. A consecutive series of 93 amputations (16% toe/foot, 33% trans-tibial, 9% through knee and 42% trans-femoral) were studied. Their mean age was 75.8 years; 21 (23%) were admitted from a nursing home and 87 (92%) were amputated due to a vascular disease and/or diabetes. Thirty days and 1-year mortality were 30 and 54%, respectively. Cox regression analysis demonstrated that the 30-day mortality was associated with older age (P = 0.01), and the number of co-morbidities (P = 0.04), when adjusted for gender, previous amputations, cause of and amputation level, and residential status. Thus, a patient with 4 or 5 co-morbidities (n = 20) was seven times more likely to die within 30 days, compared with a patient with 1 co-morbidity (n = 16). Further, the risk of not surviving increased with 7% per each additional year the patient got older. Of concern, almost one-third of patients died within 1 month. This may be unavoidable, but a multidisciplinary, optimized, multimodal pre- and postoperative programme should be instituted, trying to improve the outcome.


Assuntos
Amputação Cirúrgica/mortalidade , Extremidade Inferior/cirurgia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica/efeitos adversos , Análise de Variância , Distribuição de Qui-Quadrado , Comorbidade , Dinamarca , Feminino , Hospitais Universitários , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento
17.
Acta Orthop ; 83(1): 26-30, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22248165

RESUMO

BACKGROUND AND PURPOSE: Treatment of hip fracture patients is controversial. We implemented a new operative and supervision algorithm (the Hvidovre algorithm) for surgical treatment of all hip fractures, primarily based on own previously published results. METHODS: 2,000 consecutive patients over 50 years of age who were admitted and operated on because of a hip fracture were prospectively included. 1,000 of these patients were included after implementation of the algorithm. Demographic parameters, hospital treatment, and reoperations within the first postoperative year were assessed from patient records. RESULTS: 931 of 1,000 operative procedures were performed according to the algorithm, as compared to only 726 of 1,000 prior to its introduction (p < 0.001). After implementation of the algorithm, junior registrars still performed half of the operations, but unsupervised procedures declined from 192 of 1,000 to 105 of 1,000 (p < 0.001). The rate of reoperations declined from 18% to 12% (p < 0.001 in a multiple Cox regression analysis), with a decline of 24% to 18% for intracapsular fractures and a decline of 13% to 7% for extracapsular fractures. The proportion of bed-days caused by reoperations was reduced from 24% of total hospitalization before the algorithm was introduced to 18% after it was introduced. INTERPRETATION: It is possible to implement an algorithm for treatment of all hip fracture patients in a large teaching hospital. In our case, the Hvidovre algorithm both raised the rate of supervision and reduced the rate of reoperations. The reduced reoperation rate saved many hospital bed-days.


Assuntos
Artroplastia de Quadril/estatística & dados numéricos , Fixação Interna de Fraturas/estatística & dados numéricos , Fraturas do Quadril/cirurgia , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Feminino , Fraturas do Colo Femoral/cirurgia , Seguimentos , Fixação Interna de Fraturas/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Reoperação/estatística & dados numéricos , Resultado do Tratamento
18.
Acta Orthop ; 82(2): 166-70, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-21434790

RESUMO

BACKGROUND AND PURPOSE: In recent years, intramedullary nails (INs) for the treatment of pertrochanteric hip fractures have gained prominence relative to conventional, sliding hip screws (SHSs). There is little empirical background for this development, however. A previous series of ours suggested that the use of SHS was not adequate in situations with fragile or fractured lateral femoral walls, where it often led to lack of healing in a maximally telescoped position. We hypothesized that INs would be the superior implant in these specific circumstances. METHODS: We retrospectively examined 311 consecutive patients treated in our department between 2002 and 2008, with either an IN (n = 158) or an SHS (n = 153) mounted on a 4-hole side-plate, for an AO/OTA type 31A1-2 pertrochanteric fracture with a detached greater trochanter. The status of the lesser trochanter was assessed preoperatively and the integrity of the lateral femoral wall, fracture reduction, and position of the implants were assessed postoperatively. Reoperations due to technical failure were recorded for one year postoperatively. RESULTS: Multivariate logistic regression analysis showed that the groups were similar regarding demographic and biomechanical parameters. The lateral femoral wall was more frequently fractured during SHS implantation (42 patients) than in the IN group (9 patients) (p < 0.001). 6 (4%) of the 158 patients operated with IN had to be reoperated, as compared to 22 (14%) in the SHS group of 153 patients (p = 0.001). INTERPRETATION: IN had a lower reoperation rate than SHS in these pertrochanteric hip fractures with a detached greater trochanter. IN left more lateral femoral walls intact.


Assuntos
Pinos Ortopédicos , Fixação Intramedular de Fraturas/métodos , Fraturas do Quadril/cirurgia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Seguimentos , Fixação Intramedular de Fraturas/efeitos adversos , Fixação Intramedular de Fraturas/instrumentação , Fraturas do Quadril/diagnóstico por imagem , Humanos , Masculino , Radiografia , Reoperação , Estudos Retrospectivos , Fatores de Risco
20.
Dan Med Bull ; 57(5): A4148, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20441715

RESUMO

INTRODUCTION: Fractures of the tibial shaft are relatively common injuries. There are indications that tibial shaft fractures share characteristics in terms of site, type and local fracture mechanisms. In this study, we aimed to set up a mathematical, computer-based model using finite element analysis of the bones of the lower leg to examine if such a model is adequate for prediction of fracture locations and patterns. In future studies, we aim to use these biomechanical results to examine fracture prevention, among others, and to simulate different types of osteosynthesis and the process of bony healing. The biomechanical results are the basis for fracture healing, biomechanical fall analysis and stability analysis of osteosynthesis. MATERIAL AND METHODS: A finite element model of the bony part of the lower leg was generated on the basis of computed tomography data from the Visible Human Project. The data consisted of 21,219 3D elements with a cortical shell and a trabecular core. Three types of load of torsion, a direct lateral load and axial compression were applied. RESULTS: The finite element linear static analysis resulted in relevant fracture localizations and indicated relevant fracture patterns. CONCLUSION: In the present study, we have successfully simulated fracture mechanisms, obtained adequate fracture locations and achieved an indication of the fracture morphology. The method of fracture simulation employed showed good agreement with known clinical data and data from prior mechanical testing. This substantiates the validity of fracture simulation for future studies examining tibial fractures, fracture healing and prevention.


Assuntos
Simulação por Computador , Análise de Elementos Finitos , Fraturas da Tíbia/fisiopatologia , Fenômenos Biomecânicos , Fíbula/fisiopatologia , Fixação Interna de Fraturas , Humanos , Tíbia/fisiopatologia , Fraturas da Tíbia/cirurgia , Torção Mecânica
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