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1.
Spine J ; 23(10): 1494-1505, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37236367

RESUMO

BACKGROUND CONTEXT: Several minimally invasive lumbar interbody fusion techniques may be used as a treatment for spondylolisthesis to alleviate back and leg pain, improve function and provide stability to the spine. Surgeons may choose an anterolateral or posterior approach for the surgery however, there remains a lack of real-world evidence from comparative, prospective studies on effectiveness and safety with relatively large, geographically diverse samples and involving multiple surgical approaches. PURPOSE: To test the hypothesis that anterolateral and posterior minimally invasive approaches are equally effective in treating patients with spondylolisthesis affecting one or two segments at 3-months follow-up and to report and compare patient reported outcomes and safety profiles between patients at 12-months post-surgery. DESIGN: Prospective, multicenter, international, observational cohort study. PATIENT SAMPLE: Patients with degenerative or isthmic spondylolisthesis who underwent 1- or 2-level minimally invasive lumbar interbody fusion. OUTCOME MEASURES: Patient reported outcomes assessing disability (ODI), back pain (VAS), leg pain (VAS) and quality of life (EuroQol 5D-3L) at 4-weeks, 3-months and 12-months follow-up; adverse events up to 12-months; and fusion status at 12-months post-surgery using X-ray and/or CT-scan. The primary study outcome is improvement in ODI score at 3-months. METHODS: Eligible patients from 26 sites across Europe, Latin America and Asia were consecutively enrolled. Surgeons with experience in minimally invasive lumbar interbody fusion procedures used, according to clinical judgement, either an anterolateral (ie, ALIF, DLIF, OLIF) or posterior (MIDLF, PLIF, TLIF) approach. Mean improvement in disability (ODI) was compared between groups using ANCOVA with baseline ODI score used as a covariate. Paired t-tests were used to examine change from baseline in PRO for both surgical approaches at each timepoint after surgery. A secondary ANCOVA using a propensity score as a covariate was used to test the robustness of conclusions drawn from the between group comparison. RESULTS: Participants receiving an anterolateral approach (n=114) compared to those receiving a posterior approach (n=112) were younger (56.9 vs 62.0 years, p <.001), more likely to be employed (49.1% vs 25.0%, p<.001), have isthmic spondylolisthesis (38.6% vs 16.1%, p<.001) and less likely to only have central or lateral recess stenosis (44.9% vs 68.4%, p=.004). There were no statistically significant differences between the groups for gender, BMI, tobacco use, duration of conservative care, grade of spondylolisthesis, or the presence of stenosis. At 3-months follow-up there was no difference in the amount of improvement in ODI between the anterolateral and posterior groups (23.2 ± 21.3 vs 25.8 ± 19.5, p=.521). There were no clinically meaningful differences between the groups on mean improvement for back- and leg-pain, disability, or quality of life until the 12-months follow-up. Fusion rates of those assessed (n=158; 70% of the sample), were equivalent between groups (anterolateral, 72/88 [81.8%] fused vs posterior, 61/70 [87.1%] fused; p=.390). CONCLUSIONS: Patients with degenerative lumbar disease and spondylolisthesis who underwent minimally invasive lumbar interbody fusion presented statistically significant and clinically meaningful improvements from baseline up to 12-months follow-up. There were no clinically relevant differences between patients operated on using an anterolateral or posterior approach.


Assuntos
Fusão Vertebral , Espondilolistese , Humanos , Espondilolistese/cirurgia , Espondilolistese/etiologia , Estudos Prospectivos , Seguimentos , Vértebras Lombares/cirurgia , Constrição Patológica , Qualidade de Vida , Fusão Vertebral/efeitos adversos , Fusão Vertebral/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Dor nas Costas/etiologia , Resultado do Tratamento , Estudos Retrospectivos
2.
Bratisl Lek Listy ; 124(8): 609-614, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37218494

RESUMO

AIM: Prospective evaluation of the results of endoscopic lumbar discectomy. METHODS: 95 patients were consecutively enrolled in the study between 2017 and 2021. We monitored low back pain and sciatica according to the Visual Analogue Scale (VAS), the limitations in daily activities (Oswestry Disability Index, ODI), overall satisfaction according to a 0-100 % scale, and the rate of surgical complications and reoperations. RESULTS: Postoperatively, the VAS values of low back pain and sciatica decreased significantly from 5 to 1 point and from 6 to 1 point, respectively, and the pain remained in the tolerable range (VAS 1-2) throughout the follow-up period. The ODI score improved significantly from severe disability (46 %), preoperatively, to moderate disability at discharge and one month after surgery (29 % and 22 %, respectively), down to minimal disability at 3 and 12 months after surgery (12 % and 14 %, respectively). Overall patient satisfaction improved significantly at all follow-up time points (46 %, 70 %, 77 %, 80 %, and 78 %, respectively). Reoperation rate was 6.3 %. Cerebrospinal fluid leakage was observed in one case only (1.1 %). Transient postoperative perianogenital sensory impairment occurred in two patients (2.1 %). There was no evidence of surgical site infection or haematoma. CONCLUSION: Endoscopic discectomy provides significant pain relief and improves the patient's ability to perform activities of daily living, contributing to greater satisfaction. It is a safe method with a low risk of surgical and neurological complications (Tab. 3, Fig. 3, Ref. 27).


Assuntos
Deslocamento do Disco Intervertebral , Dor Lombar , Ciática , Humanos , Ciática/cirurgia , Deslocamento do Disco Intervertebral/cirurgia , Dor Lombar/cirurgia , Atividades Cotidianas , Resultado do Tratamento , Vértebras Lombares/cirurgia , Discotomia/métodos , Endoscopia/métodos , Estudos Retrospectivos
3.
J Orthop Surg Res ; 18(1): 165, 2023 Mar 03.
Artigo em Inglês | MEDLINE | ID: mdl-36869376

RESUMO

BACKGROUND: The objective of this prospective randomized monocentric study is to compare the speed and quality of interbody fusion of implanted porous Al2O3 (aluminium oxide) cages with PEEK (polyetheretherketone) cages in ACDF (anterior cervical discectomy and fusion). MATERIALS AND METHODS: A total of 111 patients were enrolled in the study, which was carried out between 2015 and 2021. The 18-month follow-up (FU) was completed in 68 patients with an Al2O3 cage and 35 patients with a PEEK cage in one-level ACDF. Initially, the first evidence (initialization) of fusion was evaluated on computed tomography. Subsequently, interbody fusion was evaluated according to the fusion quality scale, fusion rate and incidence of subsidence. RESULTS: Signs of incipient fusion at 3 months were detected in 22% of cases with the Al2O3 cage and 37.1% with the PEEK cage. At 12-month FU, the fusion rate was 88.2% for Al2O3 and 97.1% for PEEK cages, and at the final FU at 18 months, 92.6% and 100%, respectively. The incidence of subsidence was observed to be 11.8% and 22.9% of cases with Al2O3 and PEEK cages, respectively. CONCLUSIONS: Porous Al2O3 cages demonstrated a lower speed and quality of fusion in comparison with PEEK cages. However, the fusion rate of Al2O3 cages was within the range of published results for various cages. The incidence of subsidence of Al2O3 cages was lower compared to published results. We consider the porous Al2O3 cage as safe for a stand-alone disc replacement in ACDF.


Assuntos
Óxido de Alumínio , Discotomia , Humanos , Porosidade , Estudos Prospectivos , Cetonas , Polietilenoglicóis
4.
Polymers (Basel) ; 14(5)2022 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-35267761

RESUMO

Biodegradable biliary stents are promising treatments for biliary benign stenoses. One of the materials considered for their production is polydioxanone (PPDX), which could exhibit a suitable degradation time for use in biodegradable stents. Proper material degradation characteristics, such as sufficient stiffness and disintegration resistance maintained for a clinically relevant period, are necessary to ensure stent safety and efficacy. The hydrolytic degradation of commercially available polydioxanone biliary stents (ELLA-CS, Hradec Králové, Czech Republic) in phosphate-buffered saline (PBS) was studied. During 9 weeks of degradation, structural, physical, and surface changes were monitored using Raman spectroscopy, differential scanning calorimetry, scanning electron microscopy, and tensile and torsion tests. It was found that the changes in mechanical properties are related to the increase in the ratio of amorphous to crystalline phase, the so-called amorphicity. Monitoring the amorphicity using Raman spectroscopy has proven to be an appropriate method to assess polydioxanone biliary stent degradation. At the 1732 cm-1 Raman peak, the normalized shoulder area is less than 9 cm-1 which indicates stent disintegration. The stent disintegration started after 9 weeks of degradation in PBS, which agrees with previous in vitro studies on polydioxanone materials as well as with in vivo studies on polydioxanone biliary stents.

5.
J Thromb Thrombolysis ; 52(4): 1215-1219, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33956281

RESUMO

Spontaneous spinal epidural hematoma (SSEH) is a very rare clinical entity with potential diagnostic difficulties and which can result in severe neurological deficit. The etiology of this rare condition is largely not known, but with potential predisposition in patients on anticoagulation medication. This includes the novel anticoagulants with direct inhibition of the factor Xa mechanism (DOACs). These medications are supposed to have more predictable pharmacokinetics with fewer severe haemorrhagic adverse events in comparison with standard warfarin therapy. However, in the last few years, an increasing number of case reports have been published of haemorrhage into the central nervous system. We present a case of non-traumatic spinal epidural hematoma in the lumbar region in a patient on chronic apixaban therapy. To the best of our knowledge, it is the first described SSEH in the lumbar region associated with apixaban therapy.


Assuntos
Hematoma Epidural Espinal , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Anticoagulantes , Hematoma Epidural Espinal/induzido quimicamente , Hematoma Epidural Espinal/diagnóstico por imagem , Humanos , Região Lombossacral , Imageamento por Ressonância Magnética
6.
PLoS One ; 15(7): e0235842, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32639989

RESUMO

Biodegradable stents are promising treatments for many diseases, e.g., coronary artery disease, urethral diseases, tracheal diseases, and esophageal strictures. The mechanical properties of biodegradable stent materials play a key role in the safety and efficacy of treatment. In particular, insufficient creep resistance of the stent material could result in premature stent collapse or narrowing. Commercially available biodegradable self-expandable SX-ELLA stents made of polydioxanone monofilament were tested. A new, simple, and affordable method to measure the shear modulus of tiny viscoelastic wires is presented. The important mechanical parameters of the polydioxanone filament were obtained: the median Young's modulus was [Formula: see text] = 958 (922, 974) MPa and the shear modulus was [Formula: see text] = 357 (185, 387) MPa, resulting in a Poisson's ratio of ν = 0.34. The SX-ELLA stents exhibited significant force relaxation due to the stress relaxation of the polydioxanone monofilament, approximately 19% and 36% 10 min and 48 h after stent application, respectively. However, these results were expected, and the manufacturer and implanting clinician should be aware of the known behavior of these biodegradable materials. If possible, a biodegradable stent should be designed considering therapeutic force rather than initial force. Additionally, new and more advanced biodegradable shape-memory polymers should be considered for future study and use.


Assuntos
Implantes Absorvíveis , Materiais Biocompatíveis/química , Polidioxanona/química , Stents , Módulo de Elasticidade , Humanos , Teste de Materiais , Fenômenos Mecânicos , Desenho de Prótese
7.
J Neurosci Methods ; 329: 108459, 2020 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-31614161

RESUMO

BACKGROUND: Noninvasive diagnostic methods utilizing pulse wave measurements on the surface of the head are an important tool in diagnosing various types of cerebrovascular disease. The measurement of extraorbital pressure fluctuations reflects intraocular and intracranial pressure changes and can be used to estimate pressure changes in intracranial arteries and the collateral circulation. NEW METHOD: In this paper, we describe our patented (CZ 305757) digital device for noninvasive measuring and monitoring of orbital movements using pressure detection. We conducted preclinical tests (126 measurements on 42 volunteers) to evaluate the practical capabilities of our device. Two human experts visually assessed the quality of the pressure pulsation and discriminability among various test conditions (specifically, subject lying, sitting, and the Matas carotid occlusion test). RESULTS: The results showed that our device provided clinically relevant outcomes with a sufficient level of detail of the pulse wave and a high reliability (not less than 85%) in all clinically relevant situations. It was possible to record the effect of the Matas carotid occlusion test. COMPARISON WITH EXISTING METHOD(S): Our fully noninvasive, lightweight (185 g), portable, and wireless device provides a considerably cheaper alternative to the current diagnostic methods (e.g., transcranial ultrasound, X-ray, or MRI angiography) for specific assessment of cerebral circulation. Within a minute, it can detect the Willis circle integrity and thus eliminate the potential risks associated with the Matas test using standard EEG. CONCLUSIONS: Our device represents an improvement and a valid alternative to the current methods diagnosing regional cerebral circulation.


Assuntos
Circulação Cerebrovascular/fisiologia , Círculo Arterial do Cérebro/fisiologia , Desenho de Equipamento , Órbita , Pletismografia/instrumentação , Pletismografia/normas , Fluxo Pulsátil/fisiologia , Fluxo Sanguíneo Regional/fisiologia , Humanos , Órbita/irrigação sanguínea , Reprodutibilidade dos Testes
8.
Artigo em Tcheco | MEDLINE | ID: mdl-16669490

RESUMO

In our set of 19 operated patients with spinal myeloma it was in 17 patients (89%) the first manifestation of malignant haematological disease. Indication for admission for surgery were in 18 patients (92%) graphical signs of spinal compression of osteolytic affliction of the vertebra of unclear aetiology, which in 17 (63%) of patients were demonstrated by neurological deficit. On the basis of graphical examinations the most frequent suspicion was on metastatic affliction of the spine at unknown primary focus and the basic diagnosis was determined after the operation at most of cases. In decision about the choice of radicalness of surgery intervention important data about the type of tumour in the spine were usually missing and it especially did not make possible to estimate the life expectation of the patient. When deciding about the radicalness of the surgery, we started from the degree of spinal compression and surgical character of pathological process in the spine. The aim of the operation is to decompress the spinal cord in tumour and to stabilize the afflicted part of the spine. Radical extirpation of tumour followed with stabilization and spine reconstruction we decided to carry out in 7 patients, i.e. 37%, all of them clinically improved and from this group only 2 patients (29%) died till now. We carried out only palliative surgery on the spine in next 12 patients, i.e. in 63%, only 6 patients improved neurologically, i.e. 50% and 10 patients, i.e. 83% died till now.


Assuntos
Mieloma Múltiplo/cirurgia , Neoplasias da Coluna Vertebral/cirurgia , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/complicações , Neoplasias da Coluna Vertebral/complicações
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