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Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol.

ABSTRACT: BACKGROUND:Thoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. Percutaneous minimally invasive surgery was introduced to reduce the pain associated with the open posterior approach and reduce the morbidity of the procedure by avoiding damage and dissection of the paravertebral muscles. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open approach and the percutaneous minimally invasive approach using similar types of pedicle spine fixation systems. METHODS/DESIGNS:This study is designed as a multi-center, randomized controlled trial of patients aged 18-65?years who are scheduled to undergo surgical posterior fixation. Treatment by the conventional open approach or percutaneous minimally invasive approach will be randomly assigned. The primary outcome measure is postoperative pain, which will be measured using the visual analogue scale (VAS). The secondary outcome parameters are intraoperative bleeding, postoperative drainage, surgery time, length of hospital stay, SF-36, EQ-5D-5?l, HADS, pain medication, deambulation after surgery, intraoperative fluoroscopy time, vertebral segment kyphosis, fracture vertebral body height, compression of the vertebral canal, accuracy of the pedicle screws, and breakage or release of the implants. Patient will be followed up for 1, 2, 3, 6, 12 and 24?months postoperatively and evaluated according to the outcomes using clinical and radiological examinations, plain radiographs and computed tomografy (CT). DISCUSSION:Surgical treatment of thoracolumbar fractures by the open or percutaneous minimally invasive approach will be compared in a multicenter randomized study using similar types of fixation systems, and the results will be evaluated according to clinical and radiological parameters at 1, 2, 3, 6, 12 and 24?months of follow-up. TRIAL REGISTRATION:ClinicalTrial.gov approval number: 1.933.631, code: NCT03316703 in may 2017.

SUBMITTER: Defino HLA

PROVIDER: S-EPMC6717640 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol.

Defino Helton L A HLA Costa Herton R T HRT Nunes Altacílio A AA Nogueira Barbosa Marcello M Romero Valéria V

BMC musculoskeletal disorders 20190831 1

<h4>Background</h4>Thoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. Percutaneous minimally invasive surgery was introduced to reduce the pain associated with the open posterior approach and reduce the morbidity of the procedure by avoiding damage and dissection of the paravertebral muscles. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open appro ...[more]

PMID: 31472691

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Project description:PurposeMany minimally invasive surgical (MIS) techniques have been developed for instrumentation of spine. These MIS techniques restore stability, alignment while achieving return to function quite early as compared to open spine surgeries. The main aim of this review was to evaluate role, indications and complications of these MIS techniques in Thoracolumbar and Lumbar fractures.MethodsPubmed search using key words such as"Percutaneous pedicle screw for Thoracolumbar fractures" and "Video Assisted Thoracoscopy, Thoracoscopic, VATS for thoracolumbar, Lumbar and Spine fractures" were used till July 2016 while doing literature search. Authors analyzed all the articles, which came after search; the articles relevant to the topic were selected and used for the study. Both prospective and retrospective case control studies and randomized control trials (RCT's) were included in this review. Case reports and reviews were excluded. Studies demonstrating use of MIS in cases other than spine trauma and studies with lack of clinical follow up were excluded from this review. Variables such as number of patients, operative time and complications were evaluated in each study.ResultsAfter pubmed search, we found total 68 studies till July 2016 out of which eight studies were relevant for analysis of Video Assisted Thoracoscopy for thoracolumbar and lumbar fractures. Total 72 articles for Percutaneous pedicle screws in thoracolumbar and lumbar fractures were retrieved out of which percutaneous pedicle screws were analyzed in eleven studies and twelve studies involved comparison of percutaneous pedicle screws and conventional open techniques.ConclusionRole and Indications of the MIS techniques in spinal trauma are expanding quite rapidly. MIS techniques restore stability, alignment while achieving early return to function and lower infection rates as compared to open spine surgeries. In long term, they provide good kyphosis correction and stable fixation and fusion of spine. They are associated with long learning curve and technical challenges but with careful patient selection and in expert hands, MIS techniques may produce better results than open trauma spine surgeries.

Project description:BackgroundOpen reduction internal fixation (ORIF) has long been the conventional procedure for managing displaced patella fracture. This surgical approach has certain drawbacks, which might affect clinical outcomes and patient prognosis. Minimally invasive percutaneous fixation (MIPF) was proposed to overcome these disadvantages. Few in-depth investigations have been performed to determine the superiority of MIPF over ORIF. The aim of this study was to compare the efficacies of MIPF and ORIF for patella fractures.MethodsThe PubMed, Cochrane Library, Embase, and Scopus databases were searched for relevant studies from November 26 to December 17, 2020. Non-English publications and pediatric orthopedic articles were excluded. Statistical analysis was performed using Review Manager, version 5.4, with mean differences (MDs), standardized mean differences (SMDs), odds ratios (ORs), and respective 95% confidence intervals (CIs) calculated using a random effects model. The primary outcomes were the pain score, knee range of motion, and joint functionality. The secondary outcomes were the surgical time, complications, and implant removal rate.ResultsSix articles with a total of 304 patients were included in the meta-analysis. Pooled analysis revealed that patients with MIPF had a significantly reduced pain score (MD = - 1.30, 95% CI = - 1.77 to -0.82; p < 0.00001) and increased knee extension angles (MD = 0.72, 95% CI = 0.18 to 1.25; p = 0.009) at 3-month follow-up. Furthermore, knee flexion angles (MD = 8.96, 95% CI = 5.81 to 12.1; p < 0.00001) and joint functionality (SMD = 0.54, 95% CI = 0.21 to 0.86; p = 0.001) had statistically improved at 2 years. However, no difference was observed between MIPF and ORIF with regard to the surgical time. The risk of complications (OR = 0.10, 95% CI = 0.05 to 0.18; p < 0.00001) and implant removal rate (OR = 0.20, 95% CI = 0.07 to 0.57; p = 0.003) were significantly lower with MIPF than with ORIF.ConclusionsMIPF is more favorable than ORIF in terms of the pain score, knee range of motion, joint functionality, complications, and implant removal rate. Thus, it can be adopted as an alternative to ORIF.

Project description:BackgroundThere is uncertainty regarding delayed removal versus retention of minimally invasive screws following percutaneous fixation for thoracolumbar fractures. We conducted a systematic review and case-control study to test the hypothesis that delayed metalwork removal following percutaneous fixation for thoracolumbar fractures improves outcome.MethodsA systematic review was performed in accordance with the PRISMA guidelines. Our case-control study retrospectively evaluated 55 consecutive patients with thoracolumbar fractures who underwent percutaneous fixation in a single unit: 19 with metalwork retained (controls) and 36 with metalwork removed. Outcomes were the Oswestry Disability Index (ODI), a supplemental questionnaire, and complications.ResultsThe systematic review evaluated nine articles. Back pain was reduced in most patients after metalwork removal. One study found no difference in the ODI after versus before metalwork removal, whereas three studies reported significant improvement. Six studies noted no significant alterations in radiological markers of stability after metalwork removal. Mean complication rate was 1.7% (0-6.7). Complications were superficial wound infection, screw breakage at the time of removal, pull-out screw, and a broken rod. In the case-control study, both groups were well matched. For metalwork removal, mean operative time was 69.5 min (range 30-120) and length of stay was 1.3 days (0-4). After metalwork removal, 24 (68.6%) patients felt better, 10 (28.6%) the same and one felt worse. Two patients had superficial hematomas, one had a superficial wound infection, and none required re-operation. Metalwork removal was a significant predictor of return to work or baseline household duties (odds ratio 5.0 [1.4-18.9]). The ODI was not different between groups.ConclusionsThe findings of both the systematic review and our case-control study suggest that removal of metalwork following percutaneous fixation of thoracolumbar fractures is safe and is associated with improved outcome in most patients.

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Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol.

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Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol.

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