Project description:BackgroundIn treating patients with cervical ossification of the posterior longitudinal ligament (COPLL), a novel surgery technique - anterior controllable antedisplacement and fusion (ACAF) suggested promising clinical benefits in recent exploratory studies.MethodsThis is a multicentre, randomized, open-label, parallel-group, active controlled trial that will compare the clinical benefits of ACAF versus conventional posterior laminoplasty (LAMP) in severe COPLL patients. A total of 164 patients will be enrolled and randomized in a 1:1 ratio to either ACAF or LAMP group. The primary efficacy measure is cervical- Japanese Orthopaedic Association (C-JOA) recovery rate at 12 months post operation, which is to be derived by Hirabayashi's method from JOA data (range, 0 [worst] to 17 [normal condition]). Other important secondary efficacy endpoints include visual analogue scale (VAS) pain score (range, 0 [no pain] to 10 [most severe]), 10-item neck disability index (NDI, a total range of 0 to 50 points, the highest index the worst) and 6-level Nurick disability grade (range, 0 [mild] to 5 [severe]). Safety endpoints including adverse events, perioperative complications, and adverse events of special interest will also be assessed in this study. Full analysis set for baseline and efficacy data analyses according to the intention-to-treat principle will be established as the primary analysis population. Analysis of covariance (ANCOVA) will be used to analyze the C-JOA recovery rate, with random stratification factors (if appropriate) and the treatment group as fixed factors, and the baseline level of C-JOA score as covariate.DiscussionThis study is designed to demonstrate the clinical benefits of ACAF as compared to conventional LAMP in COPLL patients. It will provide clinical evidence that the novel surgery technique - ACAF might be more favorable in treating patients with severe cervical ossification of the posterior longitudinal ligament. (Words: 290).Trial registrationClinicalTrials.gov number, NCT04968028 .

Project description:Background:Conventional anterior cervical corpectomy and fusion (ACCF) for cervical ossification of the posterior longitudinal ligament (OPLL) is associated with a high incidence of surgery-related complications. A novel anterior decompression technique [vertebral body sliding osteotomy (VBSO)] has been developed to prevent such complications and achieve effective anterior decompression for severe OPLL patients. The purpose of this study was to describe the procedure of novel surgical technique and to evaluate the long-term surgical outcomes. Methods:Between 2012 and 2014, 24 patients underwent VBSO for treatment of cervical myelopathy caused by severe OPLL. Operation time, estimated blood loss (EBL), neurologic outcomes and perioperative complications were investigated. Various radiographic parameters such as the preoperative canal occupying ratio, postoperative canal widening, and preoperative and postoperative cervical sagittal alignment were also measured. Minimum follow-up was 24 months. Results:The mean Japanese Orthopaedic Association score for cervical myelopathy (C-JOA score) improved from 12.4±2.9 preoperatively to 16.0±1.4 at the final follow-up (P<0.05). The mean recovery rate of the C-JOA score at the final follow-up was 68.65%±17.80%. The mean operating time was 130.7±21.0 minutes and the EBL was 176.3±38.0 mL. There were no perioperative complications. Pseudarthrosis was detected in two cases at 12 months postoperatively. The average spinal canal compromised ratio by OPLL decreased from 64.0%±15.0% preoperatively to 15.5%±12.2% postoperatively (P<0.05), with an average postoperative canal widening of 5.15±1.39 mm. Conclusions:Novel anterior decompression technique termed VBSO may be an effective and safe surgical option for anterior decompression surgery in patients with severe cervical OPLL. Since, VBSO does not involve a direct manipulation of the OPLL mass or dissection of the interspace between the OPLL and dura mater, this may significantly decrease the incidence of surgery-related complications, operation time, and intraoperative blood loss.

Project description:Background and Objectives: Ossification of the ligamentum flavum (OLF) is a relatively common cause of thoracic myelopathy. Surgical treatment is recommended for patients with myelopathy. Generally, open posterior decompression, with or without fusion, is selected to treat OLF. We performed minimally invasive posterior decompression using a microendoscope and investigated the efficacy of this approach in treating limited type of thoracic OLF. Materials and Methods: Microendoscopic posterior decompression was performed for 19 patients (15 men and four women) with thoracic OLF with myelopathy aged between 35 to 81 years (mean age, 61.9 years). Neurological examination and preoperative magnetic resonance imaging (MRI) and computed tomography (CT) were used to identify the location and morphology of OLF. The surgery was performed using a midline approach or a unilateral paramedian approach depending on whether the surgeon used a combination of a tubular retractor and endoscope. The numerical rating scale (NRS) and modified Japanese Orthopedic Association (mJOA) scores were compared pre- and postoperatively. Perioperative complications and the presence of other spine surgeries before and after thoracic OLF surgery were also investigated. Results: Four midline and 15 unilateral paramedian approaches were performed. The average operative time per level was 99 min, with minor blood loss. Nine patients had a history of cervical or lumbar spine surgery before or after thoracic spine surgery. The mean pre- and postoperative NRS scores were 6.6 and 5.3, respectively. The mean recovery rate as per the mJOA score was 33.1% (mean follow-up period, 17.8 months), the recovery rates were significantly different between patients who underwent thoracic spine surgery alone (50.5%) and patients who underwent additional spine surgeries (13.7%). Regarding adverse events, one patient experienced dural tear, another experienced postoperative hematoma, and one other underwent reoperation for adjacent thoracic stenosis. Conclusion: Microendoscopic posterior decompression was applicable in limited type of thoracic OLF surgery including beak-shaped type and multi vertebral levels. However, whole spine evaluation is important to avoid missing other combined stenoses that may affect outcomes.

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Is anterior decompression and fusion superior to laminoplasty for cervical myelopathy due to ossification of posterior longitudinal ligament? A systematic review and meta-analysis.

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