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1.
World Neurosurg ; 180: e550-e559, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37778623

RESUMO

BACKGROUND: In sub-Saharan Africa, the estimated prevalence of scoliosis ranges from 3.3% to 5.5%. The management of these deformities is restricted due to lack of infrastructure and access to deformity spine surgeons. Utilizing surgical camps has been demonstrated to be efficient in transferring skills to low-resource environments; however, this has not been documented concerning deformity surgery. METHODS: We conducted a cross-sectional study. The scoliosis camp was held at a major referral spine center in East Africa. We documented information about the organization of the course. We also collected clinical and demographic patient data. Finally, we assessed the knowledge and confidence among surgeon participants on the management scoliosis. RESULTS: The camp lasted 5 days and consisted of lectures and case discussions, followed by casting and surgical sessions. Five patients were operated during the camp. All the patients in the study were diagnosed with AIS, except one with a congenital deformity. The primary curve in the spine was in the thoracic region for all patients. Six months postoperative Scoliosis Research Society-22R Scoring System (SRS-22R) score ranged from 3.3-4.5/5. 87.5% of the participants found the course content satisfactory. CONCLUSIONS: To the best of our knowledge, this is the first time an African scoliosis camp has been established. The study highlights the difficulty of conducting such a course and illustrates the feasibility of executing these complex surgeries in a resource-limited environment.


Assuntos
Escoliose , Humanos , Escoliose/cirurgia , Estudos Transversais , Região de Recursos Limitados , Estudos de Viabilidade , Qualidade de Vida , Inquéritos e Questionários , África Subsaariana
2.
Telemed J E Health ; 29(12): 1834-1842, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37126940

RESUMO

Objective: Low- and middle-income countries (LMICs) face many challenges compared to industrialized nations, most notably in regard to the health care system. Patients often have to travel long distances to receive medical care with few reliable transportation mechanisms. In time-critical emergencies, this is a significant disadvantage. One specialty that is particularly affected by this is spine surgery. Within this field, traumatic injuries and acutely compressive pathologies are often time-critical. Increasing global networking capabilities through internet access offers the possibility for telemedical support in remote regions. Recently, high-performance cameras and processors became available in commercially available smartphones. Due to their wide availability and ease of use, this could provide a unique opportunity to offer telemedical support in LMICs. Methods: We conducted a feasibility study with a neurosurgical institution in east Africa. To ensure telemedical support, a commercially available smartphone was selected as the experimental hardware. Preoperatively, resolution, contrast, brightness, and color reproduction were assessed under theoretical conditions using a test chart. Intraoperatively, the image quality was assessed under different conditions. In the first step, the instrumentation table was displayed, and the mentor surgeon marked an instrument that the mentee surgeon should recognize correctly. In the next evaluation step, the surgical field was shown on film and the mentor surgeon marked an anatomical structure, and in the last evaluation step, the screen of the X-ray machine was captured, and the mentor surgeon again marked an anatomical structure. Subjective image quality was rated by two independent reviewers using the similar modified Likert scale as before on a scale of 1-5, with 1 indicating inadequate quality and 5 indicating excellent quality. Results: The image quality during the video calls was rated as sufficient overall. When evaluating the test charts, a quality of 97% ± 5 on average was found for the chart with the white background and a quality of 84% ± 5 on average for the chart with the black background. The color reproduction, the contrast, and the reproduction of brightness were rated excellent. Intraoperatively, the visualization of the instrument table was also rated excellent. Visualization of the operative site was rated 1.5 ± 0.5 on average and it was not possible to recognize relevant anatomical structures with the required confidence for surgical procedures. Image quality of the X-ray screen was rated 1.5 ± 0.9 on average. Conclusion: Current generation smartphones have high imaging performance, high computing power, and excellent connectivity. However, relevant anatomical structures during spine surgery procedures and on the X-ray screen in the operating room could not be identified with reliability to provide adequate surgical support. Nevertheless, our study showed the potential in smartphones supporting surgical procedures in LMICs, which could be helpful in other surgical fields.


Assuntos
Cirurgiões , Telemedicina , Humanos , Smartphone , Países em Desenvolvimento , Reprodutibilidade dos Testes
3.
Brain Spine ; 2: 100883, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36248141

RESUMO

Introduction: Early onset scoliosis (EOS) represent a challenge for spine surgeons. The selection of the best treatment is complex. Some patients, such as Jehovah's Witnesses who refuse blood transfusions, are at high risk of complication when surgical treatment is required because blood loss is a major cause of morbidity and postoperative transfusion rates. Research question: Describe blood-saving techniques that allowed an extensive and invasive surgical procedure in a Jehovah's Witness patient. Material and method: 17-year-old Jehovah's Witness girl with severe 120° Cobb Lenke 1A idiopathic scoliosis started as EOS was prepared with 4 cycles of recombinant human erythropoietin, iron and folic acid supplementation that brought her hemoglobin level from 13.6 g/dl to 16.2 g/dl. In the first surgical time, a temporary rod was implanted. Spine dissection using bipolar sealer and a special electrocautery that operates at lower temperatures than traditional ones was performed. Facetectomies and multilevel Ponte osteotomies was performed using an ultrasonic bone scalpel. The second surgical time, the definitive rods were placed, and the correction of the deformity was achieved using the rod link reducer technique. Results: A good correction of the main curve in the coronal plane is achieve. The Hb nadir was 7.2 g/dl four days after the second operation. The postoperative course was uneventful. Discussion and conclusion: The integration of modern and traditional preoperative, intraoperative, and postoperative blood sparing techniques allowed us to perform an extensive and invasive surgical procedure in a Jehovah's Witness girl with a severe idiopathic scoliosis.

4.
Int J Spine Surg ; 16(5): 908, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36253080
5.
Neurosurg Focus ; 52(6): E4, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35921190

RESUMO

OBJECTIVE: Telemedicine technology has been developed to allow surgeons in countries with limited resources to access expert technical guidance during surgical procedures. The authors report their initial experience using state-of-the-art wearable smart glasses with wireless capability to transmit intraoperative video content during spine surgery from sub-Saharan Africa to experts in the US. METHODS: A novel smart glasses system with integrated camera and microphone was worn by a spine surgeon in Dar es Salaam, Tanzania, during 3 scoliosis correction surgeries. The images were transmitted wirelessly through a compatible software system to a computer viewed by a group of fellowship-trained spine surgeons in New York City. Visual clarity was determined using a modified Snellen chart, and a percentage score was determined on the smallest line that could be read from the 8-line chart on white and black backgrounds. A 1- to 5-point scale (from 1 = unrecognizable to 5 = optimal clarity) was used to score other visual metrics assessed using a color test card including hue, contrast, and brightness. The same scoring system was used by the group to reach a consensus on visual quality of 3 intraoperative points including instruments, radiographs (ability to see pedicle screws relative to bony anatomy), and intraoperative surgical field (ability to identify bony landmarks such as transverse processes, pedicle screw starting point, laminar edge). RESULTS: All surgeries accomplished the defined goals safely with no intraoperative complications. The average download and upload connection speeds achieved in Dar es Salaam were 45.21 and 58.89 Mbps, respectively. Visual clarity with the modified white and black Snellen chart was 70.8% and 62.5%, respectively. The average scores for hue, contrast, and brightness were 2.67, 3.33, and 2.67, respectively. Visualization quality of instruments, radiographs, and intraoperative surgical field were 3.67, 1, and 1, respectively. CONCLUSIONS: Application of smart glasses for telemedicine offers a promising tool for surgical education and remote training, especially in low- and middle-income countries. However, this study highlights some limitations of this technology, including optical resolution, intraoperative lighting, and internet connection challenges. With continued collaboration between clinicians and industry, future iterations of smart glasses technology will need to address these issues to stimulate robust clinical utilization.


Assuntos
Óculos Inteligentes , Países em Desenvolvimento , Estudos de Viabilidade , Humanos , Coluna Vertebral/cirurgia , Tanzânia
6.
Global Spine J ; 12(8): 1751-1760, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33590802

RESUMO

STUDY DESIGN: Retrospective multicenter. OBJECTIVES: diffuse idiopathic skeletal hyperostosis (DISH) involving the cervical spine is a rare condition determining disabling aero-digestive symptoms. We analyzed impact of preoperative settings and intraoperative techniques on outcome of patients undergoing surgery for DISH. METHODS: Patients with DISH needing for anterior cervical osteophytectomy were collected. Swallow studies and endoscopy supported imaging in targeting bone decompression. Patients characteristics, clinico-radiological presentation, outcome and surgical strategies were recorded. Impact on clinical outcome of duration and time to surgery and different surgical techniques was evaluated through ANOVA. RESULTS: 24 patients underwent surgery. No correlation was noted between specific spinal levels affected by DISH and severity of pre-operative dysphagia. A trend toward a full clinical improvement was noted preferring the chisel (P = 0.12) to the burr (P = 0.65), and whenever C2-C3 was decompressed, whether hyperostosis included that level (P = 0.15). Use of curved chisel reduced the surgical times (P = 0.02) and, together with the nasogastric tube, the risk of complications, while bone removal involving 3 levels or more (P = 0.04) and shorter waiting times for surgery (P < 0.001) positively influenced a complete swallowing recovery. Early decompressions were preferred, resulting in 66.6% of patients reporting disappearance of symptoms within 7 days. One and two recurrences respectively at clinical and radiological follow-up were registered 18-30 months after surgery. CONCLUSION: The "age of DISH" counts more than patients' age with timeliness of decompression being crucial in determining clinical outcome even with a preoperative mild dysphagia. Targeted bone resections could be reasonable in elderly patients, while in younger ones more extended decompressions should be preferred.

7.
Eur Spine J ; 30(1): 208-216, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32748257

RESUMO

PURPOSE: The eXtreme Lateral Interbody Fusion (XLIF) approach has gained increasing importance in the last decade. This multicentric retrospective cohort study aims to assess the incidence of major complications in XLIF procedures performed by experienced surgeons and any relationship between the years of experience in XLIF procedures and the surgeon's rate of severe complications. METHODS: Nine Italian members of the Society of Lateral Access Surgery (SOLAS) have taken part in this study. Each surgeon has declared how many major complications have been observed during his surgical experience and how they were managed. A major complication was defined as an injury that required reoperation, or as a complication, whose sequelae caused functional limitations to the patient after one year postoperatively. Each surgeon was finally asked about his years of experience in spine surgery and XLIF approach. Pearson correlation test was used to evaluate the association between the surgeon's years of experience in XLIF and the rate of major complications; a p-value of last than 0.05 was considered significant. RESULTS: We observed 14 major complications in 1813 XLIF procedures, performed in 1526 patients. The major complications rate was 0.7722%. Ten complications out of fourteen needed a second surgery. Neither cardiac nor respiratory nor renal complications were observed. No significant correlation was found between the surgeon's years of experience in the XLIF procedure and the number of major complications observed. CONCLUSION: XLIF revealed a safe and reliable surgical procedure, with a very low rate of major complications, when performed by an expert spine surgeon.


Assuntos
Fusão Vertebral , Humanos , Itália/epidemiologia , Vértebras Lombares/cirurgia , Reoperação , Estudos Retrospectivos , Fusão Vertebral/efeitos adversos , Coluna Vertebral , Resultado do Tratamento
8.
Aging Clin Exp Res ; 33(6): 1635-1644, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32910422

RESUMO

BACKGROUND: In the current literature, there is no consensus on the best surgical approach in hip replacement for femoral neck fractures (FNFs). AIM: The aim of this study is to compare the direct anterior approach (DAA) and the direct lateral approach (DLA) in patients treated with bipolar hemiarthroplasty (BHA) and total hip arthroplasty (THA) for FNFs. MATERIALS AND METHODS: Patients with displaced FNFs (Garden type III and IV) treated operatively using BHA and THA were enrolled. The surgical approach techniques DAA and DLA are compared. The analysed variables are: mean surgery time, number of blood units transfused perioperatively, percentage of patients transfused, perioperative complications, pain and functional outcomes at 1 and 6 months and mortality at 1, 3 and 12 months. RESULTS: Between 2015 and 2017, 37 patients underwent BHA by the DAA and 38 patients underwent BHA by the DLA, 69 patients underwent THA by the DAA and 60 patients underwent THA by the DLA. For THA, the DAA compared to the DLA had a higher mean surgery time (100.8 min vs. 97.7 min), a lower mean number of blood units transfused perioperatively (1.4 U vs. 1.9 U), a significantly lower percentage of patients transfused (53.6% vs. 71.7%), a higher rate of perioperative complications (10.1% vs. 1.6%), a lower pain referred and better functional outcomes in the first 6 postoperative months and a significantly lower mortality rate at 12 months (2.9% vs. 16.7%). For BHA, the advantages of the DAA over DLA are not as significant. CONCLUSIONS: The direct anterior approach in THA for FNFs provides significant benefits in the early post-operative period compared to the direct lateral approach in terms of functional recovery, residual pain, blood loss and mortality rate in the elderly active population. LEVEL OF EVIDENCE: Level IV, retrospective cohort study.


Assuntos
Artroplastia de Quadril , Fraturas do Colo Femoral , Hemiartroplastia , Idoso , Artroplastia de Quadril/efeitos adversos , Fraturas do Colo Femoral/cirurgia , Hemiartroplastia/efeitos adversos , Humanos , Estudos Retrospectivos
9.
World Neurosurg ; 145: e1-e6, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32777401

RESUMO

In December 2019, coronavirus disease 2019 (COVID-19) was discovered in Wuhan, Hubei province, from where it spread rapidly worldwide. COVID-19 characteristics (increased infectivity, rapid spread, and general population susceptibility) pose a great challenge to hospitals. Infectious disease, pulmonology, and intensive care units have been strengthened and expanded. All other specialties have been compelled to suspend or reduce clinical and elective surgical activities. The profound effects on spine surgery call for systematic approaches to optimizing the diagnosis and treatment of spinal diseases. Based on the experience of one Italian region, we draw an archetype for assessing the current and predicted level of stress in the health care system, with the aim of enabling hospitals to make better decisions during the pandemic. Further, we provide a framework that may help guide strategies for adapting surgical spine care to the conditions of epidemic surge.


Assuntos
COVID-19 , Cirurgia Geral/estatística & dados numéricos , Pandemias , Coluna Vertebral/cirurgia , COVID-19/epidemiologia , Tomada de Decisões Gerenciais , Árvores de Decisões , Atenção à Saúde/estatística & dados numéricos , Serviço Hospitalar de Emergência , Humanos , Itália/epidemiologia , Doenças da Coluna Vertebral/cirurgia , Doenças da Coluna Vertebral/terapia , Tempo para o Tratamento
10.
Int J Spine Surg ; 14(5): 847-851, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32991304

RESUMO

The treatment of early-onset scoliosis with magnetic growing rods has been established, but the management at the end of the lengthening program is still controversial. The options available are removal of rods and observation, removal of rods and immediate fusion, or replacement/maintenance of rods. We present 2 cases of early-onset scoliosis patients treated with Magec rods, up to skeletal maturity. In the first case of a Lenke 3 scoliosis (14 years and 11 months) with a thoracic curve of 50° and lumbar curve of 40°, we removed the rods and kept the patient under observation. After 5 months, the patient showed curve progression, with a thoracic curve of 61° and a lumbar curve of 57°. Consequently, we performed an instrumented T4 to L4 fusion with a correction of the thoracic curve of 66% and lumbar curve of 60%. In the second case of a Lenke 1 scoliosis (15 years and 10 months) with a thoracic curve of 38°, the rods were removed and the patient was kept under observation. After 10 months, following a curve progression, presenting a thoracic curve of 72°, we performed an instrumented fusion T5 to L2 and right thoracoplasty (6th to 11th ribs) with a 40% curve correction. Observing these 2 cases at the end of the treatment with Magec rods, even in case of a good and satisfying final correction, skeletal maturity, and secondary sexual characteristics, we recommend immediate instrumented spine fusion.

11.
J Orthop Surg (Hong Kong) ; 28(1): 2309499019900472, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31994969

RESUMO

PURPOSE: For anterior spine column reconstruction after corpectomy, expandable cages offer solid anterior support and allow correction of deformity, providing excellent primary stability. To provide a larger body of clinical observations concerning the effectiveness of the approach, this retrospective study examines patients treated by corpectomy and reconstruction with an expandable cage for different pathologies. METHODS: Across 5 years, 39 patients underwent vertebral reconstruction with expandable cages after single (n = 34), double (n = 4), or triple (n = 1) corpectomy. Pathologies were tumors (n = 21), fractures, or deformities in traumatic injuries (n = 14), degenerative pathology (n = 2), and infection (n = 2). Levels were cervical (n = 10), thoracic (n = 14), and lumbar (n = 15). All patients were evaluated clinically and radiographically. RESULTS: There were no cases of neurologic deterioration. Nurick grade showed significant improvement at 3 months postoperative versus preoperative (p < 0.01). Visual analog scale significantly improved preoperatively versus 3 and 12 months postoperatively (both p = 0). Regional angulation was significantly corrected, from preoperative to 3 and 12 months postoperative, at cervical, thoracic, and lumbar levels. We achieved reconstruction of the normal local anatomy with full recovery of the height of the vertebral body. Six patients (15.4%) had complications and two (5.1%) underwent revision surgery. CONCLUSIONS: In our experience, expandable cages confer stable anterior support, providing significant improvement of the segmental kyphosis angle and restoration of the original somatic height. Our clinical results are favorable, and the low rate of complications and revision accentuates the expandable cage as a valuable tool to replace the vertebral body in diverse pathologies and different spine levels.


Assuntos
Fixadores Internos , Doenças da Coluna Vertebral/cirurgia , Fraturas da Coluna Vertebral/cirurgia , Fusão Vertebral/instrumentação , Coluna Vertebral/cirurgia , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos de Cirurgia Plástica/instrumentação , Procedimentos de Cirurgia Plástica/métodos , Estudos Retrospectivos , Fusão Vertebral/métodos , Resultado do Tratamento , Adulto Jovem
12.
Acta Biomed ; 91(14-S): e2020035, 2020 12 30.
Artigo em Inglês | MEDLINE | ID: mdl-33559626

RESUMO

Background The surgical treatment of degenerative disc disease L5-S1 is considerably controversial. The purpose of this study was to evaluate the radiographic and clinical results of patients treated with AxiaLif® Technique (AxiaLif®, AMSGroup, Italy) using a minimally invasive pre-sacral approach. Methods From 2013 to 2018 a total of 52 patients have been treated (12 M, 40 F; mean age 46.3 years). Diagnosis included L5 isthmic spondylolisthesis low-grade dysplasia, primary and secondary degenerative disc disease. 43 patients have been followed for at least 2 years. Fusion assessment was based on plain radiographs and Brantigan fusion criteria at 1, 6, 12 and 24 months after surgery. All patients completed the VAS and ODI at baseline through last follow-up. Results Clinical results showed good pain resolution. VAS back demonstrated an average reduction over baseline of 50%, 57%, 71%, 77% at 3, 6, 12 and 24 months, respectively (p<0.001). ODI demonstrated an average reduction over baseline of 38%, 51%, 67%, and 72% at the same time points (p<0.001). Complete fusion was demonstrated in 65% of cases, 30% partial fusion and 5% in the absence of bony bridges visible radiographically. We had two major complications, as 1 retroperitoneal hematoma and 1 spondylodiscitis, and one minor complication, as a superficial infection of the surgical wound. Conclusions The surgical treatment of degenerative disc disease at L5-S1 with minimally invasive technique Axialif showed good radiographic and clinical outcomes with an acceptable rate of complications. Moreover, shorter hospitalization and faster functional recovery are adding factors to choice this technique.


Assuntos
Vértebras Lombares , Fusão Vertebral , Humanos , Itália , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos , Estudos Retrospectivos , Resultado do Tratamento
13.
Global Spine J ; 8(5): 512-516, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30258758

RESUMO

STUDY DESIGN: Prospective cohort study. OBJECTIVES: To assess rate and degree of interbody bone fusion and evolution in Oswestry Disability index (ODI) and visual analog scale (VAS) of pain after minimally invasive far lateral lumbar interbody fusion. METHODS: Twenty-three patients with single-level lumbar instability or degenerative disc were treated by this method and prospectively included. VAS of pain and ODI were evaluated preoperatively and at last follow-up. Computed tomography scan was performed 6 months after surgery to assess interbody fusion. RESULTS: Between preoperative and 2 years postoperative follow-up, mean VAS decreased by 2.4 points (P < .001); mean ODI improved by 21.8% (P < .001). Computed tomography scan showed fusion in all patients but one. No severe complications were observed. CONCLUSIONS: Minimally invasive far lateral lumbar interbody fusion resulted in satisfactory clinical and radiological results.

14.
Acta Orthop Traumatol Turc ; 52(3): 185-190, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29544917

RESUMO

OBJECTIVES: The aim of this study was to evaluate the results on anterior decompression and fusion with titanium mesh or expanding cage and plate fixation in patients with cervical myelopathy. METHODS: We conducted a retrospective multicentric review of 114 patients, 75 males and 39 females, with cervical myelopathy who underwent surgical treatment between July 2009 to December 2011. All surgeries were performed via a ventral approach. Based on the type of surgery the patients received, they were divided into 3 groups: group 1 consisted of 49 patients who received multilevel corpectomies and fusion with strut iliac bone graft and plates; group 2 consisted of 26 patients who received multilevel corpectomies and fusion with titanium expanding cage and plating; group 3 consisted of 39 patients who received multilevel corpectomies and fusion using titanium mesh with autologous bone graft and anterior plating. RESULTS: Decompression of the cervical spinal cord and grafting with plate fixation via a ventral approach demonstrated a high rate of improvement in neurological function with minimal complications. Fusion was documented radiologically in all cases. Eighty-three patients experienced a partial improvement and 41 had a complete recovery according to Nurick's myelopathy grading. Sixty-two patients were ranked as excellent, 48 as good, 4 as fair; unsatisfactory outcome was related to donor site complications. CONCLUSION: Spinal decompression and fusion with titanium cages and plates appears to be a safe and effective alternative in patients with cervical spinal myelopathy. LEVEL OF EVIDENCE: Level IV, therapeutic study.


Assuntos
Transplante Ósseo/métodos , Descompressão Cirúrgica , Doenças da Medula Espinal/cirurgia , Fusão Vertebral , Idoso , Placas Ósseas , Vértebras Cervicais/diagnóstico por imagem , Vértebras Cervicais/cirurgia , Descompressão Cirúrgica/instrumentação , Descompressão Cirúrgica/métodos , Feminino , Fixação Interna de Fraturas , Humanos , Ílio/transplante , Imageamento por Ressonância Magnética/métodos , Masculino , Próteses e Implantes , Procedimentos de Cirurgia Plástica/métodos , Estudos Retrospectivos , Fusão Vertebral/instrumentação , Fusão Vertebral/métodos , Telas Cirúrgicas , Titânio/uso terapêutico , Resultado do Tratamento
15.
Minerva Urol Nefrol ; 69(3): 271-277, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27813398

RESUMO

BACKGROUND: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT. METHODS: A total of 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer were enrolled. Patients were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months or alendronate (70 mg/week) for 2 years. All patient received supplemental vitamin D (600 IU/day) and supplemental calcium to maintain a calcium intake of 1200 mg per day. Effectiveness of therapy in both groups (denosumab group and alendronate group) was assessed by changes in bone turnover markers (BTMs), bone mineral density, fracture incidence, Visual Analogue Scale score for back pain, and Short Form-8 health survey score for health-related quality of life. RESULTS: In the denosumab study group, level of BTMs for bone formation were significantly increased from baseline at all time points during the study (P<0.001); in the alendronate study group level of BTMs for bone formation were increased too (P>0.05). Mean changes in BMD at final follow-up differed significantly between two groups. BMD changes at the lumbar spine at 24 months were 5.6% with denosumab vs. -1.1% with alendronate (P<0.001). CONCLUSIONS: Denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.


Assuntos
Alendronato/uso terapêutico , Conservadores da Densidade Óssea/uso terapêutico , Denosumab/uso terapêutico , Hipogonadismo/fisiopatologia , Osteoporose/tratamento farmacológico , Neoplasias de Próstata Resistentes à Castração/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Humanos , Hipogonadismo/complicações , Masculino , Pessoa de Meia-Idade , Osteoporose/etiologia , Estudos Prospectivos , Neoplasias de Próstata Resistentes à Castração/complicações
16.
Clin Cases Miner Bone Metab ; 13(3): 195-199, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28228781

RESUMO

INTRODUCTION: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. The best defense against osteoporosis in prostate cancer is to identify patients with a high risk for fracture during the first clinical visit, select an effective anti-osteoporosis agent, and advise the patient to change his lifestyle and diet to prevent further bone loss. New agents include denosumab, a human monoclonal antibody that inhibits the RANK ligand (RANKL). RANKL promotes the formation, activity, and survival of osteoclasts and, thus, supports the breakdown of bone. PURPOSE: This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT in prostate cancer patients in three European countries (Italy, France, Switzerland). PATIENTS AND METHODS: In this 24-month observation study we enrolled 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer. All patients aged ≥55 years and had a dual-energy X-ray absorptiometry (DEXA) T-score <-1.0 (hip or spine, measured within last 2 years) and ≥ 1 fragility fracture. Patients were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months or alendronate (70 mg weekly) for 2 years. All patient received supplemental vitamin D (600 IU per day) and supplemental calcium to maintain a calcium intake of 1200 mg per day. Effectiveness of therapy in both groups (denosumab group and alendronate group) was assessed by changes in bone turnover markers (BTMs), Bone Mineral Density (BMD), fracture incidence, Visual Analogue Scale (VAS) score for back pain, and Short Form-8 (SF-8TM) health survey score for health-related quality of life (HRQoL). Percent changes from baseline in BTMs and BMD were assessed using the paired t test; a P-value 0.05). Mean changes in BMD at final follow-up differed significantly between two groups. BMD changes at the lumbar spine at 24 months were 5.6% with denosumab vs -1.1% with alendronate (P<0.001). New vertebral fractures developed in fewer patients in the denosumab group than in the alendronate group during the 24-month period, although this difference was not significant (P=0.10). Back pain significantly (P<0.001) improved from baseline at all time points during the study in both study groups. SF-8 health survey scores significantly improved following treatment with both drugs. Incidence of adverse drug reactions were similar in both groups. CONCLUSION: In our study denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.

17.
Eur Spine J ; 24 Suppl 3: 405-8, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25906377

RESUMO

Over the past decade, extreme lateral interbody fusion (XLIF) has gained in popularity as a minimally invasive alternative to direct anterior lumbar interbody fusion (ALIF), and ALIF's associated morbidity. Most notably, XLIF largely avoids vascular and visceral structures that are required to be mobilized in ALIF. In this case report, the authors describe a rare complication of a bowel injury in a 70-year-old male who underwent an L3-4 and L4-5 lateral transpsoas approach for interbody fusion.


Assuntos
Colo/lesões , Vértebras Lombares/cirurgia , Fusão Vertebral/efeitos adversos , Idoso , Colo/diagnóstico por imagem , Humanos , Vértebras Lombares/diagnóstico por imagem , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Fusão Vertebral/métodos , Tomografia Computadorizada por Raios X
18.
Evid Based Spine Care J ; 5(1): 28-37, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24715870

RESUMO

STUDY DESIGN: Systematic review. STUDY RATIONALE: The surgical treatment of adult degenerative lumbar conditions remains controversial. Conventional techniques include posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF). A new direct approach known as lumbar lateral interbody fusion (LLIF), or extreme lateral interbody fusion (XLIF(®)) or direct lateral interbody fusion (DLIF), has been introduced. Objectives The objective of this article is to determine the comparative effectiveness and safety of LLIF, at one or more levels with or without instrumentation, versus PLIF or TLIF surgery in adults with lumbar degenerative conditions, and to determine which preoperative factors affect patient outcomes following LLIF surgery. MATERIALS AND METHODS: A systematic review of the literature was performed using PubMed and bibliographies of key articles. Articles were reviewed by two independent reviewers based on predetermined inclusion and exclusion criteria. Each article was evaluated using a predefined quality rating scheme. RESULTS: The search yielded 258 citations and the following met our inclusion criteria: three retrospective cohort studies (all using historical cohorts) (class of evidence [CoE] III) examining the comparative effectiveness and safety of LLIF/XLIF(®)/DLIF versus PLIF or TLIF surgery, and one prospective cohort study (CoE II) and two retrospective cohort studies (CoE III) assessing factors affecting patient outcome following LLIF. Patients in the LLIF group experienced less estimated blood loss and a lower mortality risk compared with the PLIF group. The number of levels treated and the preoperative diagnosis were significant predictors of perioperative or early complications in two studies. CONCLUSION: There is insufficient evidence of the comparative effectiveness of LLIF versus PLIF/TLIF surgery. There is low-quality evidence suggesting that LLIF surgery results in fewer complications or reoperations than PLIF/TLIF surgery. And there is insufficient evidence that any preoperative factors exist that predict patient outcome after LLIF surgery.

19.
Eur Spine J ; 21 Suppl 1: S37-42, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22402840

RESUMO

PURPOSE: To describe the clinical outcomes and complications in a consecutive series of extreme lateral interbody fusion cases. METHODS: Retrospective cohort review of 97 consecutive patients from three centers with minimum 6-month follow-up (mean 12 months). Functional status was evaluated by preoperative and last follow-up Oswestry Disability Index score. Leg and back pain were evaluated by visual analog scales. Complications were recorded and permanent complications and neurological impairment was actively investigated at last follow-up. RESULTS: No permanent neurological impairment, vascular or visceral injuries were observed. Transient neurological symptoms presented in 7% of cases, all resolved within 1 month from surgery. Transient thigh discomfort was observed in 9%. Clinical success was recorded in 92% of cases. CONCLUSIONS: Extreme lateral interbody fusion is a safe and effective technique for anterior interbody fusion.


Assuntos
Avaliação da Deficiência , Vértebras Lombares/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Fusão Vertebral/métodos , Vértebras Torácicas/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Dor nas Costas/epidemiologia , Estudos de Coortes , Europa (Continente) , Seguimentos , Humanos , Incidência , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Medição da Dor , Radiografia , Estudos Retrospectivos , Vértebras Torácicas/diagnóstico por imagem , Resultado do Tratamento
20.
SAS J ; 1(1): 36-45, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-25802577

RESUMO

BACKGROUND: Disc arthroplasty is gaining popularity for treatment of low-back pain caused by degenerative disc disease (DDD). It can involve total disc replacement or partial disc or nucleus replacement (or augmentation). Compared with total disc replacement, nucleus replacement is less invasive, has less surgical risk, has faster postoperative recovery, and doesn't "burn bridges" should further surgery be required. However, nucleus replacement has a high risk of implant expulsion because the device is not fixed to the vertebrae. Nubac is the first polyetheretherketone (PEEK)-on-PEEK articulated disc arthroplasty device designed to optimally restore the lumbar anatomy and biomechanics. METHODS: ISO 10993 standards were used to evaluate the biocompatibility of the PEEK material. Chemical and thermal-mechanical tests and in vivo study assessed PEEK's biostability after exposure to high g irradiation and harsh oxidative conditions. Biomechanical tests to evaluate kinematic properties and anatomical restoration of the implanted lumbar motion segments and implant expulsion risk assessments were performed with a human cadaveric model. Because of the novelty of PEEK-on-PEEK as a self-mating articulating material, extensive wear tests were conducted with unidirectional and coupled motions. Static and fatigue strength also were tested. Animal study with a baboon model was conducted with gross, radiographic, biomechanical, and histological evaluations at 6 and 12 months postoperatively. Preliminary clinical data were collected through a prospective multicenter cohort study. RESULTS: PEEK demonstrated exceptional biocompatibility and biodurability. Nubac restored disc height and motion segment range of motion. The unique articulating design of the Nubac demonstrated low risk of implant expulsion in a human cadaveric model. Wear tests showed that the Nubac has minimal wear and compares favorably to other disc arthroplasty materials. The Nubac also had excellent static and fatigue properties for the intended application. The animal study showed that the Nubac caused no adverse local or systematic tissue reaction and there was no detectable wear debris. The preliminary clinical data showed no major intraoperative vascular and neurological complications. There was significant Visual Analog Scale and Oswestry Disability Index score improvement. CONCLUSIONS: The preclinical data supported the design rationale, and the preliminary clinical data (level II evidence) on safety and efficacy were encouraging. CLINICAL RELEVANCE: The Nubac could be a viable first surgical option for patients with back pain caused by DDD.

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