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STUDY DESIGN: Retrospective cohort study of prospectively accrued data. OBJECTIVE: To evaluate a large, prospective, multicentre dataset of surgically-treated DCM cases on the contemporary risk of C5 palsy with surgical approach. SUMMARY OF BACKGROUND DATA: The influence of surgical technique on postoperative C5 palsy after decompression for degenerative cervical myelopathy (DCM) is intensely debated. Comprehensive analyses are needed using contemporary data and accounting for covariates. METHODS: Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012, to May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy. RESULTS: A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients that underwent posterior decompression compared to anterior decompression (11.26% vs. 3.03%, P=0.008). After multivariable regression, posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy (P=0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches. CONCLUSION: The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM. LEVEL OF EVIDENCE: Therapeutic Level II.
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BACKGROUND: Previous analyses of the US Food and Drug Administration (FDA) Investigational Device Exemption study demonstrated the superiority of i-FACTOR compared with local autograft bone in single-level anterior cervical discectomy and fusion (ACDF) at 12 and 24 months postoperatively in a composite end point of overall success. OBJECTIVE: To report the final, 6-year clinical and radiological outcomes of the FDA postapproval study. METHODS: Of the original 319 subjects enrolled in the Investigational Device Exemption study, 220 participated in the postapproval study (106 i-FACTOR and 114 control). RESULTS: The study met statistical noninferiority success for all 4 coprimary end points. Radiographic fusion was achieved in 99% (103/104) and 98.2% (109/111) in i-FACTOR and local autograft subjects, mean Neck Disability Index improvement from baseline was 28.6 (24.8, 32.3) in the i-FACTOR and 29.2 (25.6, 32.9) in the control group, respectively (noninferiority P < .0001). The neurological success rate at 6 years was 95.9% (70/73) in i-FACTOR subjects and 93.7% (70/75) in local autograft subjects (noninferiority P < .0001). Safety outcomes were similar between the 2 groups. Secondary surgery on the same or different cervical levels occurred in 20/106 (18.9%) i-FACTOR subjects and 23/114 (20.2%) local autograft subjects ( P = .866). Secondary outcomes (pain, SF-36 physical component score and mental component score) in i-FACTOR subjects were similar to those in local autograft subjects. CONCLUSION: i-FACTOR met all 4 FDA-mandated noninferiority success criteria and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion for cervical radiculopathy through 6 years postoperatively. Safety outcomes are acceptable, and the clinical and functional outcomes observed at 12 and 24 months remained at 72 months.
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Vértebras Cervicais , Fusão Vertebral , Humanos , Resultado do Tratamento , Seguimentos , Autoenxertos/cirurgia , Vértebras Cervicais/cirurgia , Discotomia , PeptídeosRESUMO
Background Multiple studies describe the outcomes of patients undergoing single-level and multilevel posterolateral lumbar fusion (PLF). However, a comparison of outcomes between single-level and two-level PLF is lacking. The aim of this prospective cohort study was to compare outcomes between single-level and two-level instrumented PLF. Methods A total of 42 patients were enrolled at nine US centers between October 2015 and June 2017. Data included radiologic outcomes, visual analog scale (VAS) Back and Leg Pain, disability per the Oswestry Disability Index (ODI), and health-related quality of life (QoL) per 36-Item Short Form Survey version 2.0 (SF-36v2) at six weeks and three, six, 12, and 24 months. Results Twelve-month and 24-month follow-ups were completed by 38 (90.5%) and 32 (76.2%) subjects, respectively. The average age was 67 years, and 54.8% were female. Twenty-six received single-level PLF, and 16 received two-level PLF. In the single-level group, there was one reoperation, two postoperative infections, and one dural tear. In the two-level group, there was one postoperative infection. The surgeon computed tomography (CT)-based evaluation of fusion rate was 67.6% (25/37) at 12-month follow-up and 94.1% (32/34) at 24-month follow-up. The third-party evaluation of fusion rate was 52.8% (19/36) at six months, 81.1% (30/37) at 12 months, and 86.5% (32/37) at 24 months. There was a tendency toward a higher fusion rate in single-level compared with two-level PLF. The ODI, SF-36v2 Mental Component Score (MCS), and VAS Back Pain and Leg Pain outcomes improved by the first follow-up visit in both the single-level and two-level groups. Improvement in the ODI was 5.86 (95% confidence interval (CI): 0.03-11.69) points greater in the single-level group compared with the two-level group. Conclusions Compared with the two-level PLF subjects, single-level PLF subjects had better functional outcomes and reported higher satisfaction with the outcome of surgery but showed similar fusion, pain, and generic health-related quality of life outcomes. Both single-level and two-level PLF subjects demonstrated high fusion rates in association with improvements in pain, functional, and quality of life outcomes, as well as high satisfaction levels.
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AIMS: The aim of our study was to investigate the effect of asymmetric crosslinked polyethylene liner use on the risk of revision of cementless and hybrid total hip arthroplasties (THAs). METHODS: We undertook a registry study combining the National Joint Registry dataset with polyethylene manufacturing characteristics as supplied by the manufacturers. The primary endpoint was revision for any reason. We performed further analyses on other reasons including instability, aseptic loosening, wear, and liner dissociation. The primary analytic approach was Cox proportional hazard regression. RESULTS: A total of 213,146 THAs were included in the analysis. Overall, 2,997 revisions were recorded, 1,569 in THAs with a flat liner and 1,428 in THAs using an asymmetric liner. Flat liner THAs had a higher risk of revision for any reason than asymmetric liner THAs when implanted through a Hardinge/anterolateral approach (hazard ratio (HR) 1.169, 95% confidence interval (CI) 1.022 to 1.337) and through a posterior approach (HR 1.122, 95% CI 1.108 to 1.346). There was no increased risk of revision for aseptic loosening when asymmetric liners were used for any surgical approach. A separate analysis of the three most frequently used crosslinked polyethylene liners was in agreement with this finding. When analyzing THAs with flat liners only, THAs implanted through a Hardinge/anterolateral approach were associated with a reduced risk of revision for instability compared to posterior approach THAs (HR 0.561 (95% CI 0.446 to 0.706)). When analyzing THAs with an asymmetric liner, there was no significant difference in the risk of revision for instability between the two approaches (HR 0.838 (95% CI 0.633 to 1.110)). CONCLUSION: For THAs implanted through the posterior approach, the use of asymmetric liners reduces the risk of revision for instability and revision for any reason. In THAs implanted through a Hardinge/anterolateral approach, the use of an asymmetric liner was associated with a reduced risk of revision. The effect on revision for instability was less pronounced than in the posterior approach. Cite this article: Bone Joint J 2021;103-B(9):1479-1487.
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Artroplastia de Quadril/instrumentação , Prótese de Quadril , Polietileno/química , Desenho de Prótese , Reoperação/estatística & dados numéricos , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Prótese , Sistema de RegistrosRESUMO
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.
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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 JovemRESUMO
STUDY DESIGN: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. OBJECTIVE: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. METHODS: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. RESULTS: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline (P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. CONCLUSIONS: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD.
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BACKGROUND: Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy. METHODS: This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18-80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8-14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828. FINDINGS: From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference -0·38 points (-0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications. INTERPRETATION: In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study. FUNDING: AOSpine North America.
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Vértebras Cervicais/cirurgia , Craniectomia Descompressiva/métodos , Degeneração do Disco Intervertebral/tratamento farmacológico , Degeneração do Disco Intervertebral/cirurgia , Fármacos Neuroprotetores/uso terapêutico , Procedimentos Neurocirúrgicos/métodos , Riluzol/uso terapêutico , Compressão da Medula Espinal/tratamento farmacológico , Compressão da Medula Espinal/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Método Duplo-Cego , Determinação de Ponto Final , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuroprotetores/efeitos adversos , Dor Pós-Operatória/epidemiologia , Riluzol/efeitos adversos , Resultado do TratamentoRESUMO
AIMS: The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA). METHODS: Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening. Cox proportional hazard regression was the primary analytical approach. Manufacturing variables included resin type, crosslinking radiation dose, terminal sterilization method, terminal sterilization radiation dose, stabilization treatment, total radiation dose, packaging, and face asymmetry. Total radiation dose was further divided into G1 (no radiation), G2 (> 0 Mrad to < 5 Mrad), G3 (≥ 5 Mrad to < 10 Mrad), and G4 (≥ 10 Mrad). RESULTS: A total of 5,329 THAs were revised, 1,290 of which were due to aseptic loosening. Total radiation dose, face asymmetry, and stabilization treatments were found to significantly affect implant survival. G1 had the highest revision risk for any reason and for aseptic loosening and G3 and G4 the lowest. Compared with G1, the adjusted hazard ratio for G2 was 0.74 (95% confidence interval (CI) 0.64 to 0.86), G3 was 0.36 (95% CI 0.30 to 0.43), and G4 was 0.38 (95% CI 0.31 to 0.47). The cumulative incidence of revision for aseptic loosening at 12 years was 0.52 and 0.54 per 100 THAs for G3 and G4, respectively, compared with 1.95 per 100 THAs in G1. Asymmetrical liners had a lower revision risk due to aseptic loosening and reasons other than aseptic loosening compared with symmetric (flat) liners. In G3 and G4, stabilization with vitamin E and heating above melting point performed best. CONCLUSION: Polyethylene liners with a total radiation dose of ≥ 5 Mrad, an asymmetrical liner face, and stabilization with heating above the melting point demonstrate best survival. Cite this article: Bone Joint J 2020;102-B(1):90-101.
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Artroplastia de Quadril/normas , Prótese de Quadril/normas , Polietileno , Adulto , Idoso , Artroplastia de Quadril/instrumentação , Artroplastia de Quadril/estatística & dados numéricos , Tecnologia Biomédica , Feminino , Prótese de Quadril/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese/normas , Desenho de Prótese/estatística & dados numéricos , Falha de Prótese , Reoperação/estatística & dados numéricos , Fatores de RiscoRESUMO
BACKGROUND: The effect on functional and quality of life (QOL) outcomes of surgery in elderly degenerative cervical myelopathy (DCM) patients has not been definitively established. OBJECTIVE: To evaluate the effect of older age on the functional and QOL outcomes after surgery in an international, multi-center cohort of patients with DCM. METHODS: 107 patients aged over 70 years old (mean 75.6 ± 4.4 years) were enrolled in the AOSpine CSM-North America and International studies. A propensity-matched cohort of 107 patients was generated from the remaining 650 adults aged <70 years old (mean 56.3 ± 9.6 years), matched to gender, complexity of surgery, co-morbidities, and baseline functional impairment (modified Japanese Orthopedic Association scale (mJOA). Functional, disability, and QOL outcomes were compared at baseline and at two years post-operatively, along with peri-operative adverse events. RESULTS: Both cohorts were equivalently matched. At two years, both cohorts showed significant functional improvement from the baseline but the magnitude was greater in the younger cohort (mJOA 3.8 (3.2-4.4) vs. 2.6 (2.0-3.3); p = 0.007). This difference between groups was also observed in the SF-36 physical component summary (PCS) and mental component summary (MCS) outcomes (p = <0.001, p = 0.007), but not present in the neck disability index (NDI) scores (p = 0.094). Adverse events were non-significantly higher in the elderly cohort (22.4% vs. 15%; p = 0.161). CONCLUSIONS: Elderly patients showed an improvement in functional and QOL outcomes after surgery for DCM, but the magnitude of improvement was less when compared to the matched younger adult cohort. An age over 70 was not associated with an increased risk of adverse events.
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BACKGROUND: The JOURNEY II Bi-Cruciate Stabilizing Total Knee System (BLINDED) is a second-generation guided-motion knee implant that has been used in over 100,000 primary total knee arthroplasties (TKAs) worldwide. However, performance information is limited. METHODS: Data for 2059 primary TKAs were abstracted at 7 US and 3 European sites. Estimates of cumulative incidence of revision were compared with registry data for cemented posterior-stabilized implants. RESULTS: Average age was 64.3 years (range, 18-91); 58.5% were females; and 12.3% TKAs were in subjects younger than 55 years. Patellae were resurfaced in 95.9%. Median time since primary TKA was 4.2 years; longest was 6.1 years; and 78.9% were 3 years or more since primary TKA. Of 67 revisions (3.2%), 20 (30%) involved femoral or tibial component removal compared to 42% in the Australian Joint Registry (Australian Orthopedic Association National Joint Replacement Registry). All-component revisions accounted for 15 of 67, femoral component only for 2 of 67, tibial component only for 3 of 67, patellar component with/without tibial insert exchange for 17 of 67, and isolated tibial insert exchange for 30 of 67. In addition, there were 18 reoperations without component exchange. Component revision indications were infection (33%), mechanical loosening (21%), fracture of bone around the joint (16%), and instability (15%). Kaplan-Meier revision estimate was 3.1 and 3.6 per 100 TKAs at 3 and 5 years, respectively, compared to Australian Orthopedic Association National Joint Replacement Registry estimates of 3.1 and 4.1 per 100 TKAs. CONCLUSION: The revision rate for the second-generation implant was similar to cemented posterior-stabilized registry controls.
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Artroplastia do Joelho/instrumentação , Artroplastia do Joelho/métodos , Desenho de Prótese , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/efeitos adversos , Europa (Continente) , Feminino , Fêmur/cirurgia , Humanos , Internacionalidade , Estimativa de Kaplan-Meier , Articulação do Joelho/cirurgia , Prótese do Joelho/efeitos adversos , Masculino , Pessoa de Meia-Idade , Patela/cirurgia , Falha de Prótese , Infecções Relacionadas à Prótese , Sistema de Registros , Reoperação/efeitos adversos , Tíbia/cirurgia , Estados Unidos , Adulto JovemRESUMO
BACKGROUND: Preoperative duration of symptoms may significantly impact outcomes in patients treated surgically for degenerative cervical myelopathy (DCM). OBJECTIVE: To (i) analyze whether duration of symptoms is associated with preoperative functional impairment, disability, and quality of life and (ii) determine the optimal timing for decompressive surgery. METHODS: Patients with DCM were prospectively enrolled in either the AOSpine North American or International study at 26 global sites (n = 757). Postoperative functional impairment was evaluated at 1-yr using the modified Japanese Orthopaedic Association (mJOA) score. Change scores between baseline and 1-yr were computed for the mJOA. Duration of symptoms was dichotomized into a "short" and "long" group at several cut-offs. Analysis of covariance was used to evaluate differences in change scores on the mJOA between duration of symptoms groups in 4-mo increments. RESULTS: Our cohort consisted of 424 men and 255 women, with a mean duration of symptoms of 26.1 ± 36.4 mo (0.25-252 mo). Duration of symptoms was not correlated with preoperative mJOA, Nurick, Neck Disability Index, or Short-Form (SF)-36 Physical and Mental Component Scores. Patients with a duration of symptoms shorter than 4 mo had significantly better functional outcomes on the mJOA than patients with a longer duration of symptoms (>4 mo). Thirty-two months was also a significant cut-off. CONCLUSION: Patients who are operated on within 4 mo of symptom presentation have better mJOA outcomes than those treated after 4 mo. It is recommended that patients with DCM are diagnosed in a timely fashion and managed appropriately.
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Procedimentos Neurocirúrgicos , Doenças da Medula Espinal/complicações , Doenças da Medula Espinal/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Vértebras Cervicais/cirurgia , Estudos de Coortes , Feminino , Humanos , Hipestesia/etiologia , Pessoa de Meia-Idade , Debilidade Muscular/etiologia , Estudos Prospectivos , Reflexo Anormal , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Total knee arthroplasty (TKA) can provide pain relief and good long-term results. However, nearly 30% of post-surgical patients are unsatisfied due to persistent pain and functional deficits. A second-generation bi-cruciate stabilized TKA device has a post-cam mechanism with an asymmetric femoral component, a polyethylene insert, and a medially concave and laterally convex shape. The device is designed to provide guided motion, and thus improve knee kinematics by more closely approximating a normal knee. The aim of this study was to evaluate early complication and revision rates of the second-generation device and to compare its clinical performance to the first-generation device. MATERIALS AND METHODS: In this retrospective, longitudinal, non-concurrent cohort study, 140 TKAs were performed using the second-generation device on 131 patients from 2012 to 2016, and 155 TKAs were performed using the first-generation device on 138 patients from 2009 to 2012. Primary outcomes were occurrence of revisions and reoperations. RESULTS: There were 31 reoperations [3.21 per 100 observed component years (OCY)] in 22 (2.28 per 100 OCY) TKAs in the first-generation device cohort compared to five reoperations (1.92 per 100 OCY) in four TKAs (1.54 per 100 OCY) in the second-generation device cohort. The adjusted hazard ratio (HR) was 3.50 (P = 0.0254). There were 21 revisions (2.17 per 100 OCY) in 16 (1.66 per 100 OCY) TKAs in the first-generation device cohort, compared to only three revisions (1.15 per 100 OCY) in two TKAs (0.77 per 100 OCY) in the second-generation device cohort. The adjusted HR was 4.16 (P = 0.0693). CONCLUSION: The improved design of the second-generation device appears to be associated with a lower risk of reoperation and revision compared to that of the first-generation device. LEVEL OF EVIDENCE: III.
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Artroplastia do Joelho/instrumentação , Articulação do Joelho/cirurgia , Prótese do Joelho/efeitos adversos , Falha de Prótese/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Estudos de Coortes , Feminino , Humanos , Estimativa de Kaplan-Meier , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , RiscoRESUMO
BACKGROUND: This study was designed to identify preoperative predictors of survival in surgically treated patients with metastatic epidural spinal cord compression (MESCC), to examine how these predictors are related to 8 prognostic models, and to perform the first full external validation of these models in accordance with the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement. METHODS: One hundred forty-two surgically treated patients with MESCC were enrolled in a prospective, multicenter North American cohort study and were followed for 12 months or until death. Cox regression was used. Noncollinear predictors with < 10% missing data, with ≥ 10 events per stratum, and with P < .05 in a univariate analysis were tested through a backward stepwise selection. For the original and revised Tokuhashi prognostic scoring systems (PSSs), Tomita PSS, modified Bauer PSS, van der Linden PSS, Bartels model, Oswestry Spinal Risk Index, and Bollen PSS, this study examined calibration graphically, discrimination with Harrell c-statistics, and survival stratified by risk groups with the Kaplan-Meier method and log-rank test. RESULTS: The following were significant in the univariate analysis: type of primary tumor, sex, organ metastasis, body mass index, preoperative radiotherapy to MESCC, physical component (PC) of the 36-Item Short Form Health Survey, version 2 (SF-36v2), and EuroQol 5-Dimension (EQ-5D) Questionnaire. Breast, prostate and thyroid primary tumor (HR: 2.9; P =.0005), presence of organ metastasis (hazard ratio (HR): 2.0; P = .005) and SF-36v2 PC (HR: 0.95; P < .0001) were associated with survival in multivariable analysis. Predicted prognoses poorly matched observed values on calibration plots; Bartels model calibration slope was 0.45. Bollen PSS (0.61; 95% CI: 0.58-0.64) and Bartels model (0.68; 95% CI: 0.65-0.71) had the lowest and highest c-statistics, respectively. CONCLUSIONS: The primary tumor type (breast, prostate, or thyroid), an absence of organ metastasis, and a lower degree of physical disability are preoperative predictors of longer survival for surgical MESCC patients. These results are in keeping with current models. This full external validation of 8 prognostic PSSs or model of survival in surgical MESCC patients has revealed that calibration is poor, especially for long-term survivors, whereas discrimination is possibly helpful.
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Neoplasias Epidurais/mortalidade , Neoplasias Epidurais/cirurgia , Modelos Estatísticos , Compressão da Medula Espinal/mortalidade , Compressão da Medula Espinal/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Descompressão Cirúrgica/mortalidade , Descompressão Cirúrgica/estatística & dados numéricos , Neoplasias Epidurais/complicações , Neoplasias Epidurais/secundário , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , América do Norte/epidemiologia , Valor Preditivo dos Testes , Prognóstico , Compressão da Medula Espinal/diagnóstico , Compressão da Medula Espinal/etiologia , Neoplasias da Coluna Vertebral/complicações , Neoplasias da Coluna Vertebral/mortalidade , Neoplasias da Coluna Vertebral/secundário , Neoplasias da Coluna Vertebral/cirurgia , Análise de Sobrevida , Resultado do Tratamento , Adulto JovemRESUMO
STUDY DESIGN: A prospective observational international study. OBJECTIVE: The aim of this study was to evaluate outcomes of decompressive surgery in patients with very severe degenerative cervical myelopathy (DCM). SUMMARY OF BACKGROUND DATA: Although decompressive surgery has been evidenced as a safe and effective approach for patients with myelopathic deficiencies, studies have suggested residual disability following treatment in patients with more severe disease presentation. METHODS: Postoperative outcomes of 60 patients with very severe DCM (modified Japanese Orthopaedic Association [mJOA] score ≤8) were compared to outcomes of 188 patients with severe DCM (mJOA 9-11). Postimputation follow-up rate was 93.1%. Unadjusted and adjusted analyses were performed using two-way repeated measures of covariance. RESULTS: The two cohorts were similar in demographics, length of duration of myelopathy symptoms, source of stenosis, and surgical approaches used to decompress the spine. The very severe and severe cohorts differed in preoperative Nurick grades (4.97 vs. 3.91, respectively, Pâ<â0.0001) and Neck Disability Index scores (45.20 vs. 56.21, respectively, Pâ=â0.0006). There were no differences in Short Form 36 (SF-36v2) physical (PCS) and mental (MCS) component summary scores. Both cohorts improved in mJOA, Nurick, Neck Disability Index, and SF-36v2 PCS and MCS scores. Despite the substantial postoperative improvements, patients in both cohorts had considerable residual symptoms. Two-thirds of the patients in the very severe cohort had severe (mJOA ≤11) or moderate (mJOA ≤ 14) myelopathy symptoms at 24 months follow-up. Longer duration of disease was associated with poorer treatment response. CONCLUSION: Decompressive surgery is effective in patients with very severe DCM; however, patients have significant residual symptoms and disability. The very severe subgroup (mJOA ≤8) of patients with DCM represents a distinct group of patients and their different clinical trajectory is important for clinicians and patients to recognize. Duration of symptoms negatively affects chances for recovery. Whenever possible, patients with DCM should be treated before developing very severe symptomatology. LEVEL OF EVIDENCE: 2.
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Vértebras Cervicais/cirurgia , Descompressão Cirúrgica/tendências , Complicações Pós-Operatórias/diagnóstico , Índice de Gravidade de Doença , Doenças da Medula Espinal/diagnóstico , Doenças da Medula Espinal/cirurgia , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Doenças da Medula Espinal/epidemiologia , Resultado do TratamentoRESUMO
BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) is a progressive degenerative spine disease and the most common cause of spinal cord impairment in adults worldwide. Few studies have reported on regional variations in demographics, clinical presentation, disease causation, and surgical effectiveness. PURPOSE: The objective of this study was to evaluate differences in demographics, causative pathology, management strategies, surgical outcomes, length of hospital stay, and complications across four geographic regions. STUDY DESIGN/SETTING: This is a multicenter international prospective cohort study. PATIENT SAMPLE: This study includes a total of 757 symptomatic patients with DCM undergoing surgical decompression of the cervical spine. OUTCOME MEASURES: The outcome measures are the Neck Disability Index (NDI), the Short Form 36 version 2 (SF-36v2), the modified Japanese Orthopaedic Association (mJOA) scale, and the Nurick grade. MATERIALS AND METHODS: The baseline characteristics, disease causation, surgical approaches, and outcomes at 12 and 24 months were compared among four regions: Europe, Asia Pacific, Latin America, and North America. RESULTS: Patients from Europe and North America were, on average, older than those from Latin America and Asia Pacific (p=.0055). Patients from Latin America had a significantly longer duration of symptoms than those from the other three regions (p<.0001). The most frequent causes of myelopathy were spondylosis and disc herniation. Ossification of the posterior longitudinal ligament was most prevalent in Asia Pacific (35.33%) and in Europe (31.75%), and hypertrophy of the ligamentum flavum was most prevalent in Latin America (61.25%). Surgical approaches varied by region; the majority of cases in Europe (71.43%), Asia Pacific (60.67%), and North America (59.10%) were managed anteriorly, whereas the posterior approach was more common in Latin America (66.25%). At the 24-month follow-up, patients from North America and Asia Pacific exhibited greater improvements in mJOA and Nurick scores than those from Europe and Latin America. Patients from Asia Pacific and Latin America demonstrated the most improvement on the NDI and SF-36v2 PCS. The longest duration of hospital stay was in Asia Pacific (14.16 days), and the highest rate of complications (34.9%) was reported in Europe. CONCLUSIONS: Regional differences in demographics, causation, and surgical approaches are significant for patients with DCM. Despite these variations, surgical decompression for DCM appears effective in all regions. Observed differences in the extent of postoperative improvements among the regions should encourage the standardization of care across centers and the development of international guidelines for the management of DCM.
Assuntos
Descompressão Cirúrgica/efeitos adversos , Deslocamento do Disco Intervertebral/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Doenças da Medula Espinal/epidemiologia , Espondilose/epidemiologia , Adulto , Idoso , Vértebras Cervicais/cirurgia , Europa (Continente) , Feminino , Humanos , Deslocamento do Disco Intervertebral/patologia , Deslocamento do Disco Intervertebral/cirurgia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , América do Norte , Complicações Pós-Operatórias/patologia , Doenças da Medula Espinal/patologia , Doenças da Medula Espinal/cirurgia , Espondilose/patologia , Espondilose/cirurgiaRESUMO
BACKGROUND: i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE: To report 2-yr follow-up. METHODS: Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. RESULTS: At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. CONCLUSION: Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.
Assuntos
Substitutos Ósseos/uso terapêutico , Transplante Ósseo/métodos , Discotomia/métodos , Fusão Vertebral/métodos , Resultado do Tratamento , Adulto , Autoenxertos , Transplante Ósseo/efeitos adversos , Vértebras Cervicais/cirurgia , Discotomia/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Fusão Vertebral/efeitos adversos , Transplante Autólogo/métodos , Estados Unidos , United States Food and Drug AdministrationRESUMO
BACKGROUND: Although dysphagia is a common complication after anterior cervical decompression and fusion, important risk factors have not been rigorously evaluated. Furthermore, the impact of dysphagia on neurological and quality-of-life outcomes is not fully understood. The aim of this study was to determine the prevalence of and risk factors for dysphagia, and the impact of this complication on short and long-term clinical outcomes, in patients treated with anterior cervical decompression and fusion. METHODS: Four hundred and seventy patients undergoing a 1-stage anterior or 2-stage anteroposterior cervical decompression and fusion were enrolled in the prospective AOSpine CSM (Cervical Spondylotic Myelopathy) North America or International study at 26 global sites. Logistic regression analyses were conducted to determine important clinical and surgical predictors of perioperative dysphagia. Preoperatively and at each follow-up visit, patients were evaluated using the modified Japanese Orthopaedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short Form-36 Health Survey (SF-36). A 2-way repeated-measures analysis of covariance was used to evaluate differences in outcomes at 6 and 24 months between patients with and those without dysphagia, while controlling for relevant baseline characteristics and surgical factors. RESULTS: The overall prevalence of dysphagia was 6.2%. Bivariate analysis showed the major risk factors for perioperative dysphagia to be a higher comorbidity score, older age, a cardiovascular or endocrine disorder, a lower SF-36 Physical Component Summary score, 2-stage surgery, and a greater number of decompressed levels. Multivariable analysis showed patients to be at an increased risk of perioperative dysphagia if they had an endocrine disorder, a greater number of decompressed segments, or 2-stage surgery. Both short and long-term improvements in functional, disability, and quality-of-life scores were comparable between patients with and those without dysphagia. CONCLUSIONS: The most important predictors of dysphagia are an endocrine disorder, a greater number of decompressed levels, and 2-stage surgery. At the time of both short and long-term follow-up, patients with perioperative dysphagia exhibited improvements in functional, disability, and quality-of life scores that were similar to those of patients without dysphagia. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Assuntos
Vértebras Cervicais/cirurgia , Transtornos de Deglutição/epidemiologia , Espondilose/cirurgia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Descompressão Cirúrgica , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Qualidade de Vida , Fatores de Risco , Fusão Vertebral , Resultado do TratamentoRESUMO
BACKGROUND CONTEXT: It remains unclear whether cervical laminoplasty (LP) offers advantages over cervical laminectomy and fusion (LF) in patients undergoing posterior decompression for degenerative cervical myelopathy (DCM). PURPOSE: The objective of this study is to compare outcomes of LP and LF. STUDY DESIGN/SETTING: This is a multicenter international prospective cohort study. PATIENT SAMPLE: A total of 266 surgically treated symptomatic DCM patients undergoing cervical decompression using LP (N=100) or LF (N=166) were included. OUTCOME MEASURES: The outcome measures were the modified Japanese Orthopaedic Association score (mJOA), Nurick grade, Neck Disability Index (NDI), Short-Form 36v2 (SF36v2), length of hospital stay, length of stay in the intensive care unit, treatment complications, and reoperations. METHODS: Differences in outcomes between the LP and LF groups were analyzed by analysis of variance and analysis of covariance. The dependent variable in all analyses was the change score between baseline and 24-month follow-up, and the independent variable was surgical procedure (LP or LF). In the analysis of covariance, outcomes were compared between cohorts while adjusting for gender, age, smoking, number of operative levels, duration of symptoms, geographic region, and baseline scores. RESULTS: There were no differences in age, gender, smoking status, number of operated levels, and baseline Nurick, NDI, and SF36v2 scores between the LP and LF groups. Preoperative mJOA was lower in the LP compared with the LF group (11.52±2.77 and 12.30±2.85, respectively, p=.0297). Patients in both groups showed significant improvements in mJOA, Nurick grade, NDI, and SF36v2 physical and mental health component scores 24 months after surgery (p<.0001). At 24 months, mJOA scores improved by 3.49 (95% confidence interval [CI]: 2.84, 4.13) in the LP group compared with 2.39 (95% CI: 1.91, 2.86) in the LF group (p=.0069). Nurick grades improved by 1.57 (95% CI: 1.23, 1.90) in the LP group and 1.18 (95% CI: 0.92, 1.44) in the LF group (p=.0770). There were no differences between the groups with respect to NDI and SF36v2 outcomes. After adjustment for preoperative characteristics, surgical factors and geographic region, the differences in mJOA between surgical groups were no longer significant. The rate of treatment-related complications in the LF group was 28.31% compared with 21.00% in the LP group (p=.1079). CONCLUSIONS: Both LP and LF are effective at improving clinical disease severity, functional status, and quality of life in patients with DCM. In an unadjusted analysis, patients treated with LP achieved greater improvements on the mJOA at 24-month follow-up than those who received LF; however, these differences were insignificant following adjustment for relevant confounders.
Assuntos
Degeneração do Disco Intervertebral/cirurgia , Laminectomia/efeitos adversos , Laminoplastia/efeitos adversos , Adulto , Feminino , Humanos , Laminectomia/normas , Laminoplastia/normas , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , América do Norte , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Qualidade de VidaRESUMO
BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) represents the most common cause of non-traumatic spinal cord impairment in adults. Surgery has been shown to improve neurologic symptoms and functional status, but it is costly. As sustainability concerns in the field of health care rise, the value of care has come to the forefront of policy decision-making. Evidence for both health-related quality of life outcomes and financial expenditures is needed to inform resource allocation decisions. PURPOSE: This study aimed to estimate the lifetime incremental cost-utility of surgical treatment for DCM. DESIGN/SETTING: This is a prospective observational cohort study at a Canadian tertiary care facility. PATIENT SAMPLE: We recruited all patients undergoing surgery for DCM at a single center between 2005 and 2011 who were enrolled in either the AOSpine Cervical Spondylotic Myelopathy (CSM)-North America study or the AOSpine CSM-International study. OUTCOME MEASURES: Health utility was measured at baseline and at 6, 12, and 24 months following surgery using the Short Form-6D (SF-6D) health utility score. Resource expenditures were calculated on an individual level, from the hospital payer perspective over the 24-month follow-up period. All costs were obtained from a micro-cost database maintained by the institutional finance department and reported in Canadian dollars, inflated to January 2015 values. METHODS: Quality-adjusted life year (QALY) gains for the study period were determined using an area under the curve calculation with a linear interpolation estimate. Lifetime incremental cost-to-utility ratios (ICUR) for surgery were estimated using a Markov state transition model. Structural uncertainty arising from lifetime extrapolation and the single-arm cohort design of the study were accounted for by constructing two models. The first included a highly conservative assumption that individuals undergoing nonoperative management would not experience any lifetime neurologic decline. This constraint was relaxed in the second model to permit more general parameters based on the established natural history. Deterministic and probabilistic sensitivity analyses were employed to account for parameter uncertainty. All QALY gains and costs were discounted at a base of 3% per annum. Statistical significance was set at the .05 level. RESULTS: The analysis included 171 patients; follow-up was 96.5%. Mean age was 58.2±12.0 years and baseline health utility was 0.56±0.14. Mean QALY gained over the 24-month study period was 0.139 (95% confidence interval: 0.109-0.170, p<.001) and the mean 2-year cost of treatment was $19,217.82±12,404.23. Cost associated with the operation comprised 65.7% of the total. The remainder was apportioned over presurgical preparation and postsurgical recovery. Three patients required a reoperation over the 2-year follow-up period. The costs of revision surgery represented 1.85% of the total costs. Using the conservative model structure, the estimated lifetime ICUR of surgical intervention was $20,547.84/QALY gained, with 94.7% of estimates falling within the World Health Organization definition of "very cost-effective" ($54,000 CAD). Using the more general model structure, the estimated lifetime ICUR of surgical intervention was $11,496.02/QALY gained, with 97.9% of estimates meeting the criteria to be considered "very cost-effective." CONCLUSIONS: Surgery for DCM is associated with a significant quality of life improvement. The intervention is cost-effective and, from the perspective of the hospital payer, should be supported.
Assuntos
Vértebras Cervicais/cirurgia , Análise Custo-Benefício , Procedimentos Neurocirúrgicos/economia , Assistência Centrada no Paciente/economia , Qualidade de Vida , Canadá , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reoperação/economia , Doenças da Medula Espinal/economia , Doenças da Medula Espinal/cirurgiaRESUMO
STUDY DESIGN: Analysis of a combined prospective dataset. OBJECTIVE: To compare clinical outcomes in patients with and without preexisting depression or bipolar disorder undergoing surgery for degenerative cervical myelopathy (DCM). SUMMARY OF BACKGROUND DATA: Psychiatric comorbidities, including depression, have been associated with worse clinical outcomes after lumbar spine surgery; however, it is unclear whether these psychiatric disorders are also predictive of outcomes in patients undergoing surgery for the treatment of DCM. METHODS: Four hundred and one patients with symptomatic DCM were enrolled in the prospective AOSpine International or North America study at twelve North American sites. Patients were evaluated preoperatively and at 6, 12, and 24 months using the modified Japanese Orthopedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short- Form 36v2 (SF-36v2) Health Survey. A mixed model analytic approach was used to evaluate differences in outcomes at 24 months among patients with and without psychiatric disorders, while controlling for relevant baseline characteristics and surgical factors. RESULTS: Ninety-seven patients (24.19%) were diagnosed with preexisting depression or bipolar disorder. There were more females (65.98%) with these psychiatric disorders than males (34.02%) (Pâ<â0.0001). Patients with psychiatric comorbidities were more likely to have cardiovascular (Pâ=â0.0177), respiratory (Pâ<â0.0001), gastrointestinal (Pâ<â0.0001), rheumatologic (Pâ=â0.0109), and neurologic (Pâ=â0.0309) disorders. At 24 months after surgery, patients in both groups demonstrated significant improvements on the mJOA, Nurick, NDI, and SF-36v2 Physical Component Score (PCS). Patients with depression or bipolar disorder, however, did not exhibit a significant or clinically important change on the SF-36v2 Mental Component Score (MCS). There were no differences in mJOA and Nurick scores at 24 months among patients in each group. Improvement in NDI, SF-36v2 PCS, and MCS, however, were smaller in patients with depression or bipolar disorder than those without. CONCLUSION: Patients with depression or bipolar disorder have smaller functional and quality of life improvements after surgery compared to patients without psychiatric comorbidities. LEVEL OF EVIDENCE: 2.