Hyperbaric oxygen therapy for spinal cord injury: A protocol for systematic review and meta-analysis.

BACKGROUND: Hyperbaric oxygen (HBO) therapy can prevent further spinal cord injury (SCI) caused by spinal cord ischemia-reperfusion injury to the maximum extent, which has been reported increasingly in recent years. However its security and effectiveness still lack of high-quality medical evidence. In this study, we will perform a systematic review of previously published randomized controlled trials (RCTs) to evaluate the efficacy and safety of HBO therapy for SCI. METHODS: All potential RCTs on HBO therapy for SCI will be searched from the following electronic databases: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, Wanfang database and Chinese Biomedical Literature Database. We will search all electronic databases from their initiation to the September 30, 2020 in spite of language and publication date. Two contributors will independently select studies from all searched literatures, extract data from included trials, and evaluate study quality for all eligible RCTs using Cochrane risk of bias tool, respectively. Any confusion will be resolved by consulting contributor and a consensus will be reached. We will utilize RevMan 5.3 software to pool the data and to conduct the data analysis. RESULTS: The quality of the assessments will be assessed through Grading of Recommendations Assessment, Development, and Evaluation. Data will be disseminated through publications in peer-reviewed journals. CONCLUSION: This study will provide evidence to evaluate the efficacy and safety of HBO therapy for SCI at evidence-based medicine level. TRIAL REGISTRATION NUMBER: INPLASY 2020100084.

Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: Protocol for a randomized controlled trial.

BACKGROUND: Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH. METHODS: Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling ("positive" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations. OBJECTIVES: To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH. TRIAL REGISTRATION NUMBER: ChiCTR1900020888; Pre-results.

Comparison of the perioperative parameters between computer navigation and fluoroscopy guidance for pedicle screw placement: A protocol for a systematic review and meta-analysis.

BACKGROUND: Computer navigation technology is gradually applied to the placement of pedicle screws, but its security and effectiveness still lack of high-quality evidence-based medical evidence. In this study, we will perform a systematic review of previously published randomized controlled trials to investigate the accuracy and effectiveness of computer navigation vsersus fluoroscopy guidance for pedicle screw placement. METHODS: All study protocols adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed (MEDLINE), The excerpta medica database, Web of Science (science and social science citation index), The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Methodology Register), China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, WanFang, Chinese Biomedical Literature Database will be searched for relevant articles up to 18 April, 2020. We will include randomized controlled trials of computer navigation and fluoroscopy guidance for pedicle screw placement. The Cochrane Handbook (v6) will be used for assessment of study bias and reliability, and a meta-analysis will be performed using STATA 16.0. The main outcome will be the proportion of accurate implanted screws. Additional outcomes including: overall complication rate, radiation dosage, length of surgery, length of stay, estimated blood loss. RESULTS: The quality of the assessments will be assessed through Grading of Recommendations Assessment, Development, and Evaluation. Data will be disseminated through publications in peer-reviewed journals. CONCLUSION: We will evaluate the accuracy and other perioperative parameters between computer navigation and fluoroscopy guidance for pedicle screw placement. TRIAL REGISTRATION NUMBER: PROSPERO 2020 CRD42020172087.