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PURPOSE: It remains unclear whether the long-term results of RCTs regarding the outcome of microdiscectomy for lumbosacral radicular syndrome (LSRS) are generalizable. The purpose of this study was to determine the external validity of the outcome preseneted in RCTs after microdicectomy for LSRS in a patient cohort from a high-volume spine center. METHODS: Between 2007 and 2010, 539 patients had a single level microdiscectomy for MRI disk-related LSRS of whom 246 agreed to participate. Questionnaires included visual analogue scores (VAS) for leg pain, RDQ, OLBD, RAND-36 and Likert scores for recovery, leg and back pain. Lumbar re-operation(s) were registered. RESULTS: Mean age was 51.3, and median time of follow-up was 8.0 years. Re-operation occurred in 64 (26%) patients. Unfavorable perceived recovery was noted in 85 (35%) patients, and they had worse leg and back pain than the 161 (65%) patients with a favorable recovery: median VAS for leg pain 28/100 mm versus 2/100 mm and median VAS for back pain 9/100 mm versus 3/100 mm, respectively. In addition, the median RDQ and OLBD scores differed significantly: 9 vs 3 for RDQ and 26 vs 4 for OLBD, respectively (p < 0.001). CONCLUSION: In this cohort study, the long-term results after microdiscectomy for LSRS were less favorable than those obtained in RCTs, possibly caused by less strict patient selection than in RCTs. Our findings emphasize that patients, who do not meet the same inclusion criteria for surgery as in RCTs, should be informed about the chances of a less favorable result.
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Deslocamento do Disco Intervertebral , Radiculopatia , Ciática , Estudos de Coortes , Discotomia/métodos , Humanos , Deslocamento do Disco Intervertebral/complicações , Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Pessoa de Meia-Idade , Radiculopatia/complicações , Radiculopatia/cirurgia , Ciática/etiologia , Ciática/cirurgia , Resultado do TratamentoRESUMO
OBJECTIVE: To prevent complications following decompressive craniectomy (DC), such as sinking skin flap syndrome, studies suggested early cranioplasty (CP). However, several groups reported higher complication rates in early CP. We studied the clinical characteristics associated with complications in patients undergoing CP, with special emphasis on timing. METHODS: A single-center observational cohort study was performed, including all patients undergoing CP from 2006 to 2018, to identify predictors of complications. RESULTS: 145 patients underwent CP: complications occurred in 33 (23%): 18 (12%) epi/subdural hemorrhage, 10 (7%) bone flap infection, 4 (3%) hygroma requiring drainage, and 1 (1%) post-CP hydrocephalus. On univariate analysis, acute subdural hematoma as etiology of DC, symptomatic cerebrospinal fluid (CSF) flow disturbance (hydrocephalus) prior to CP, and CP within three months after DC were associated with higher complication rates. On multivariate analysis, only acute subdural hematoma as etiology of DC (OR 7.5; 95% CI 1.9-29.5) and symptomatic CSF flow disturbance prior to CP (OR 2.9; 95% CI 1.1-7.9) were associated with higher complication rates. CP performed within three months after DC was not (OR 1.4; 95% CI 0.5-3.9). Pre-CP symptomatic CSF flow disturbance was the only variable associated with the occurrence of epi/subdural hemorrhage. (OR 3.8; 95% CI 1.6-9.0) CONCLUSION: Cranioplasty has high complication rates, 23% in our cohort. Contrary to recent systematic reviews, early CP was associated with more complications (41%), explained by the higher incidence of pre-CP CSF flow disturbance and acute subdural hematoma as etiology of DC. CP in such patients should therefore be performed with highest caution.
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Craniectomia Descompressiva/estatística & dados numéricos , Procedimentos de Cirurgia Plástica/efeitos adversos , Procedimentos de Cirurgia Plástica/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Crânio/cirurgia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
OBJECTIVE: Since 2009, we have performed skin augmentation using a Gore-Tex patch as a last-resort measure to reduce intracranial pressure (ICP) in uncontrollable brain swelling during decompressive craniectomy (DC). Here, we report our experience and outcome in a consecutive series of patients undergoing DC with skin augmentation (DC+S). METHODS: In 2009-2015, a prospective database was created registering all patients who underwent DC+S when ICP increased >25 mm Hg while approximating the skin edges after DC (or when closing the skin was impossible because of uncontrollable brain swelling in patients without an ICP monitoring catheter). Patients' baseline characteristics and 1-year outcome were compared with patients undergoing DC without the need of skin augmentation in the same time frame. Outcome according to the Glasgow Outcome Scale (GOS) was dichotomized into favorable (GOS score 4-5) and unfavorable (GOS 1-3). RESULTS: Of a total of 180 consecutive patients with DC, 20 (11%) underwent DC+S. Four (20%) survived favorably, 2 (10%) unfavorably, and 14 (70%) died (compared with 36%, 22%, and 42%, respectively, in patients with standard DC). Four of 7 patients in whom DC+S was performed ≥24 hours after injury or at second surgery survived favorably, versus none of the 13 patients in whom DC+S was performed <24 hours after injury and at first surgery. Two of 10 patients surviving the first week after DC+S had a skinplasty-related infection. CONCLUSIONS: Decompressive craniectomy with skin augmentation may be used as a last-resort measure in cases of severe brain swelling despite DC.
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Edema Encefálico/cirurgia , Craniectomia Descompressiva/métodos , Politetrafluoretileno , Pele Artificial , Adolescente , Adulto , Idoso , Edema Encefálico/diagnóstico por imagem , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Lactente , Hipertensão Intracraniana/diagnóstico por imagem , Hipertensão Intracraniana/cirurgia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Adulto JovemRESUMO
OBJECT: Patients with recurrent sciatica due to repeated reherniation of the intervertebral disc carry a poor prognosis for recovery and create a large burden on society. There is no consensus about the best treatment for this patient group. The goal of this study was to evaluate the 12-month results of the placement of stand-alone Trabecular Metal cages in these patients. METHODS: The authors performed a retrospective analysis of 26 patients with recurrent disc herniations treated with stand-alone posterior lumbar interbody fusion (PLIF) with Trabecular Metal cages. At 1 year patients were evaluated using the Roland Morris Disability Questionnaire (RMDQ) and a visual analog scale (VAS) for back and leg pain. Furthermore, Likert scores of perceived recovery and satisfaction with the treatment were recorded. Lumbar spine radiographs after 1 year were compared with postoperative radiographs to measure subsidence. Stability of the operated segment was assessed using dynamic radiography. RESULTS: The patient group consisted of 26 patients (62% male) with a mean age of 45.7 ± 11.4 years (± SD). Patients had a history of 1 (31%), 2 (42%), or more (27%) discectomies at the same level. The mean follow-up period was 15.3 ± 7.3 months. At follow-up the mean VAS score for pain in the affected leg was 36.7 ± 27.9. The mean VAS score for back pain was 42.5 ± 30.2. The mean RMDQ score at follow-up was 9.8 ± 6.2. Twelve (46%) of the 26 patients had a global perceived good recovery. With respect to treatment satisfaction, 18 patients (69%) were content or very content with the operation and would recommend it. Disc height was increased immediately postoperatively, and at the 1-year follow-up it was still significantly higher compared with the preoperative height (mean 41% ± 38.7%, range -25.7 to 126.8, paired t-test, both p < 0.001), although a mean of 7.52% ± 11.6% subsidence occurred (median 2.0% [interquartile range 0.0%-10.9%], p < 0.003). No significant correlation between subsidence and postoperative back pain was found (Spearman's rho -0.2, p = 0.459). Flexion-extension radiographs showed instability in 1 patient. CONCLUSIONS: Although only 46% of patients reported a good recovery with significant reductions in back and leg pain, 85% of patients reported at least some benefit from the operation, and a marked improvement in working status at follow-up was noted. In view of previously published poor results of instrumented lumbar fusion for patients with failed back surgery syndrome, the present data indicate that Trabecular Metal interbody fusion cages can be used in a stand-alone fashion and should not always need supplemental posterior fixation in patients with recurrent disc herniation without spinal instability, although a long-term follow-up study is warranted.
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Dor nas Costas/cirurgia , Fixadores Internos , Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/cirurgia , Fusão Vertebral/instrumentação , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Satisfação do Paciente , Recuperação de Função Fisiológica , Recidiva , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: This study describes the 5 years' results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. DESIGN: A randomised controlled trial. SETTING: Nine Dutch hospitals. PARTICIPANTS: Five years' follow-up data from 231 of 283 patients (82%) were collected. INTERVENTION: Early surgery or an intended 6 months of conservative treatment. MAIN OUTCOME MEASURES: Scores from Roland disability questionnaire, visual analogue scale (VAS) for leg and back pain and a Likert self-rating scale of global perceived recovery were analysed. RESULTS: There were no significant differences between groups on the 5 years' primary outcome scores. Despite at least 6 months of conservative treatment 46% of the conservatively allocated patients were treated surgically because of severe leg pain and disability. Forty-nine (21%) patients had an unsatisfactory recovery at 5 years and the recovery pattern showed that there was a variable group of 66 patients (31%) with at least one unsatisfactory outcome at 1, 2 or 5 years of follow-up. Multivariate logistic regression showed that age (>40; OR 2.42 (95% CI 1.16 to 5.02)), severity of leg pain (VAS >70; OR 3.32 (95% CI 1.69 to 6.54)) and the Mc Gill affective score (score >3; OR 6.23 (95% CI 2.23 to 17.38)) were the only significant predictors for an unsatisfactory outcome at 5 years. CONCLUSIONS: In the long term, 8% of the patients with sciatica never showed any recovery and in at least 23%, sciatica appears to result in ongoing complaints, which fluctuate over time, irrespective of treatment. Prolonged conservative care might give patients a fair chance for pain and disability to resolve without surgery, but with the risk to receive delayed surgery after prolonged suffering of sciatica. Age above 40 years, severe leg pain at baseline and a higher affective Mc Gill pain score were predictors for unsatisfactory recovery. Trial Registry ISRCT No 26872154.
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OBJECTIVE: Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor. METHODS: We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up. RESULTS: At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed. CONCLUSION: The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.