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  Citation statistics : Table of Contents
   2017| January-March  | Volume 2 | Issue 1  
    Online since February 28, 2017

 
 
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RESEARCH ARTICLES
Effect of tourniquet use during total knee arthroplasty on global inflammatory cytokine changes associated with ischemia- reperfusion injury
Brian Wu, Ryan Graff, Ido Badash, Joseph G Skeate, Christianne Lane, Ibrahim Mansour, Ravi Rao, Anthony Yi, Jarrad Merriman, C Thomas Vangsness, George Rick Hatch III, Larry Dorr, Paul Gilbert, E Todd Schroeder
January-March 2017, 2(1):1-10
DOI:10.4103/2542-4157.201056  
The use of tourniquets during total knee arthroplasties has been debated given the possibility that prolonged application of a tourniquet may result in ischemia-reperfusion injury, potentially contributing to post-operative muscle atrophy. The goal of this study is to elucidate the influence that tourniquet use may have on the induction of ischemia-reperfusion injury in muscle tissue following total knee arthroplasties surgeries. We hypothesize that prolonged operative use of a tourniquet will cause global increases in pro-inflammatory cytokines indicating the occurrence of ischemia-reperfusion injury, which may contribute to post-operative muscle atrophy. Fifty patients undergoing total knee arthroplasties surgeries were separated into three groups: no tourniquet (n = 17), operative tourniquet (n = 15), and tourniquet during implant cementation (n = 18). Induction of ischemia-reperfusion injury was evaluated by measuring changes in inflammatory cytokines in blood samples collected from an antecubital vein before and after surgery. Analysis suggests statistically significant differences in the concentrations of specific cytokines depending on variable tourniquet application. Overall, both pro-inflammatory and anti-inflammatory cytokines (including tumor necrosis factor-α, interleukin 1β, 4, 5, 12, and monocyte chemtactic protein-1) were found to increase upon application of tourniquets during cementation and decrease without tourniquet use or upon application of operative tourniquets. In general only slight changes in inflammatory cytokines occurred based on altered tourniquet use during total knee arthroplasties. Using global changes in inflammatory cytokine levels as an indicator of ischemia-reperfusion injury, these data may suggest that the use of a tourniquet does not significantly contribute to induction of ischemia-reperfusion injury in total knee arthroplasty surgeries. However, additional studies comparing local plasma cytokine changes near the tourniquet site and utilizing larger sample sizes are necessary to determine if tourniquets can be used in total knee arthroplasty without inducing ischemia-reperfusion injury.
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Risk factors for ligamentum flavum hypertrophy in lumbar spinal stenosis patients from the Xinjiang Uygur Autonomous Region, China: protocol for a retrospective, single-center study
Gang Zhou, Yu-kun Zhang, Wei-min Huang
January-March 2017, 2(1):11-17
DOI:10.4103/2542-4157.201057  
Background: Ligamentum flavum hypertrophy is one important cause of spinal stenosis. Ligamentum flavum thickness of more than 4 mm measured on computed tomography (CT) and magnetic resonance imaging is considered hypertrophy, but causes of hypertrophy and distribution characteristics remain poorly understood. Previous studies showed that the ligamentum flavum thickness at the segments L2/3 , L3/4 , L4/5 and L5/S1 was positively correlated with age. It remains unclear whether ligamentum flavum thickness is associated with nationality, sex and obesity. Methods/Design: We conducted a retrospective, single-center, case analysis at the Sixth Affiliated Hospital, Xinjiang Medical University, China. We collected lumbar CT imaging data of 104 patients diagnosed with lumbar spinal stenosis in the Sixth Affiliated Hospital, Xinjiang Medical University from May 2012 to May 2016. The primary outcome was the ligamentum flavum thickness of patients with different nationalities, sexes, heights, ages, and weights. The secondary outcomes were the morphology of lumbar vertebrae in patients with different nationalities, sexes, heights, ages, and weights; the correlation of nationality, sex, height, age, and weight with ligamentum flavum thickness; results of multiple linear regression analysis of relevant factors for ligamentum flavum hypertrophy. Discussion: This study will determine the variations in the ligamentum flavum thickness of lumbar spinal stenosis patients of different nationalities, sexes, heights, ages, and weights in the Xinjiang Uygur Autonomous Region by measuring the ligamentum flavum thickness using CT, and analyzing risk factors for ligamentum flavum hypertrophy; the findings will provide quantitative reference data for preventing lumbar spinal stenosis induced by ligamentum flavum hypertrophy in the Xinjiang Uygur Autonomous Region. Trial registration: ClinicalTrials.gov identifier: NCT03057353. Ethics: The study protocol has been approved by the Ethics Committee of Sixth Affiliated Hospital, Xinjiang Medical University, China, and conducted in accordance with the Helsinki Declaration, formulated by the World Medical Association. Informed consent: Written informed consent was obtained from all participants.
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MISCELLANEOUS
Information for Authors - Clinical Trials in Orthopedic Disorders

January-March 2017, 2(1):42-52
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RESEARCH ARTICLES
New bone fixation plate for the repair of avulsion fracture of the tibial attachment of the posterior cruciate ligament: study protocol for a prospective, open-label, self-controlled, clinical trial
Guang-dong Chen, Tong-jun Cao
January-March 2017, 2(1):18-23
DOI:10.4103/2542-4157.201060  
Background: Avulsion fractures of the tibial attachment of the posterior cruciate ligament have been repaired using open reduction and rivet fixation, hollow screw fixation, or arthroscopic reconstruction of the posterior cruciate ligament. These methods ignore the importance of early tension reconstruction of the posterior cruciate ligament, so their efficacies are uncertain. Determining the optimal fixation method and how best to restore knee stability remain controversial. Methods/Design: We will conduct a prospective, single-center, self-controlled, clinical trial at the Cangzhou Central Hospital, Hebei Province, China. Fracture fragments and the injured posterior cruciate ligament will be exposed in twenty patients with avulsion fracture of the tibial attachment of the posterior cruciate ligament through a posterior approach and open reduction. The posterior cruciate ligament will be reconstructed with a new type of bone plate. All patients will be followed for 3 and 12 months. Primary outcome: The Hospital for Special Surgery knee score will be used to evaluate knee function preoperatively and 3 and 12 months postoperatively. Secondary outcomes: Lysholm Knee Scoring Scale, X-ray, computed tomography, and magnetic resonance imaging will be used to assess knee morphology preoperatively and 3 and 12 months postoperatively. Patient satisfaction will also be assessed at 3 and 12 months postoperatively. Discussion: This trial will evaluate a newly-designed plate fixation device for early tension reconstruction of the posterior cruciate ligament to repair avulsion fractures of the tibial attachment of the posterior cruciate ligament and restore knee stability. This trial will verify the plate's efficacy, provide an experimental basis for treating avulsion fractures of the tibial attachment of the posterior cruciate ligament, and provide a method of maximizing knee stability. Trial registration: ClinicalTrials.gov identifier: NCT03059368. Ethics: The study protocol has been approved by the Ethics Committee of Cangzhou Central Hospital of China. All protocols will be in accordance with Helsinki Declaration, formulated by the World Medical Association. Informed consent: Written informed consent will be provided by participants.
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STUDY PROTOCOL
Effect of periprosthetic fracture on hip function after femoral neck-preserving total hip arthroplasty: study protocol for a prospective, single-center, self-controlled trial with 2-year follow-up
Di Qin, Yong-tai Han, Hui-jie Li
January-March 2017, 2(1):24-30
DOI:10.4103/2542-4157.194809  
Background: Total hip replacement with a collum femoris preserving (CFP) short stem prosthesis can reportedly reduce postoperative complications and preserve maximum bone tissue for long-term revision. However, CFP replacement has a relatively high risk of intraoperative periprosthetic fractures that can seriously harm hip function recovery. Therefore, this study aims to analyze risk factors for periprosthetic fractures and develop preventive measures to reduce postoperative complications. Methods/Design: A prospective, single-center, self-controlled, open-label study with 2-year follow-up will be carried out at the Department of Orthopedics, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. We will analyze data from 25 patients who undergo total hip replacement with the CFP prosthesis. Primary outcome measure is Harris hip score preoperatively and 6, 12, and 24 months postoperatively. Secondary outcome measures include fracture severity as assessed by periprosthetic fracture classification according to the American Academy of Orthopaedic Surgeons guidelines, and bone healing as assessed by CT and radiographic findings preoperatively and 6, 12, and 24 months postoperatively, including parameters of the proximal and mesal medullary cavity of the fractured femur (width of the medullary cavity at the point 20 mm above the midpoint of the small trochanter, at the midpoint of the small trochanter, at the point 20 mm below the midpoint of the small trochanter, and at the fracture line; width of the corresponding prostheses), intertrochanteric width, femoral neck-stem angle, femoral neck anteversion, femoral neck length, ratio of the distal end of the prosthesis to the medullary space, and height of the femoral calcar. Other outcome measures are multiple logistic regression analysis results of risk factors for periprosthetic fracture during hip replacement, and the incidence of adverse events within 24 months postoperatively. Discussion: This study will be expected to provide references for reducing the incidence of periprosthetic fracture during hip replacement with the CFP prosthesis. Trial registration: ClinicalTrials.gov identifier: NCT02981823. Ethics: Approved by the Ethics Committee of the Third Hospital of Hebei Medical University, China (approval number: KE2016-011-1), the study protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from all participants prior to the trial.
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MRI appearance of injured ligaments and/or tendons of the ankle in different positions: study protocol for a single-center, diagnostic clinical trial
Guo-bin Liu, Guo-ping Zhang, Qing-yun Ren, Li-cun Lei, Feng Zhao, Hong-yang Gao, Chao-hua Zhu, Ya-guang Li
January-March 2017, 2(1):31-35
DOI:10.4103/2542-4157.201058  
Background: The ankle joint is capable of flexion and extension, including plantar flexion and dorsiflexion, which enables it to act as a lever and a support, and to transmit movement. Ankle joint function is seriously threatened by ankle injury, which is often accompanied by fracture and ligament injury. Previously, diagnosis of ankle injury mainly relied on clinical signs and radiographic examination. However, radiographic examination is insufficient for ankle injury diagnosis, as it cannot clearly diagnose damage to the surrounding ligaments, tendons and other soft tissues. Multisequence and multiplanar MRI is currently the optimal noninvasive method for high-resolution determination of soft tissue deformations, but little has been reported on the diagnostic accuracy of MRI for ankle ligament and tendon injury. Here, we describe our protocol to evaluate the diagnostic value of MRI for ligament and tendon injury of the ankle in its normal position, and during complete plantar flexion and dorsiflexion. Methods/Design: This is a single-center, prospective, diagnostic trial that will be completed at the First Affiliated Hospital of Hebei Medical University, China. Sixty cases have been recruited, including 30 normal ankle joint cases and 30 cases of ankle ligament and tendon injury. All cases underwent MRI with the ankle joint in normal position, complete plantar flexion and complete dorsiflexion, and the multiposition MRI results were compared. The primary outcome measure is the sensitivity of MRI to detect ligament and tendon injury of the ankle during complete plantar flexion. The secondary outcomes include the specificity, positive and negative predictive values, and positive and negative likelihood ratios of MRI for diagnosis of ligament and tendon injury of the ankle in the complete plantar position as well as the rate of correct diagnosis; specificity and sensitivity, positive and negative predictive values, and positive and negative likelihood ratios in normal ankle position or in the complete dorsiflexion position as well as the rate of correct diagnosis; morphology of the ankle on multiposition MRI. Discussion: This study aims to determine the rate of correct diagnosis of ankle ligament and tendon injury using MRI, to clarify the diagnostic value of MRI for ankle ligament and tendon injury, and provide a quantitative MRI diagnostic standard for developing a reasonable surgical strategy. Trial registration: ClinicalTrials.gov identifier: NCT03049423. Ethics: The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Hebei Medical University in China (approval No. 2015076), and performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent was obtained from all participants prior to the trial.
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Genetic risk factors of degenerative intervertebral disc disease: a case-control study
Qiang Shen, Ji Qian, Qiang Wu, Ya-ping Luo, Hua Yu, Liang Zhu, Hao Ding, Jian Chen, Wen-cheng Lu
January-March 2017, 2(1):36-41
DOI:10.4103/2542-4157.201059  
Background: The etiology of degenerative disc disease (DDD) is complex and includes genetic, gender, age, environment and traumatic factors. Obvious relatedness of DDD patients has been documented. Genetic factors account for 75% of the risk of DDD and although many genes have been associated with DDD, no specific marker genes have been found. Therefore, we will establish a biological sample library and database of DDD patients who have a family history of the disease and who require surgical treatment. To identify pathogenic DDD genes, we will screen the patient database for genes that contain polymorphisms and/or are differentially expressed. Methods/Design: This is a single-center, case-control study, which will be performed in Shanghai First People's Hospital, School of Medicine, Shanghai Jiao Tong University, China. A total of 2,000 subjects will be prospectively collected from the wards and clinics of Shanghai First People's Hospital. These patients will consist of 1,000 DDD patients with a family history, 500 DDD patients without a family history, and 500 normal controls. Blood or intervertebral disc tissue samples will be collected. Total RNA will be sequenced to identify differentially expressed genes. Genome-wide association analysis will be performed using high-throughput microarrays and single nucleotide polymorphism microarrays and pooling (SNP-MAP). The primary outcome measure of this study will be the percentage of differentially expressed genes in DDD patients with or without a family history. The secondary outcome measures will be sequence variation in differentially expressed genes, SNP genotyping, routine liver and kidney function tests, routine blood tests, routine urine tests, and morphology of degenerated spinal discs. Discussion: This study aims to identify the pathological and physiological risk factors of DDD from the perspective of genetics by screening for genes that are differentially expressed in DDD and to correlate them with DDD, and to identify precise molecular targets for drug development and diagnostics. Trial registration: The study protocol was registered in Chinese Clinical Trial Registry (registration number: ChiCTR-COC-16009617) on October 10 th , 2016. Ethics: This study has been approved by Scientific Research Project Ethics Committee, Shanghai First People's Hospital, China (approval number: 2016KY166-2) and will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent regarding study protocol and treatment procedure will be obtained prior to involvement in the clinical trial.
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