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   Table of Contents - Current issue
Coverpage
April-June 2018
Volume 3 | Issue 2
Page Nos. 1-22

Online since Monday, June 18, 2018

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RESEARCH ARTICLES  

Developing a consensus on indications, timing and core outcomes for surgical fixation of rib fracture: a Delphi technique protocol p. 1
Helen MA Ingoe, Catriona McDaid, William Eardley, Catherine Hewitt
DOI:10.4103/2542-4157.233622  
Background and objectives: Developing a robust surgical trial requires evidenced based indications and selection of relevant outcomes. The aim of this study is to develop a consensus on indications and timing and a core outcome set for surgical fixation of rib fractures following blunt chest trauma. Design: A systematic review of the literature and identification of a core outcome set using a Delphi survey. Methods: Systematic review has identified multiple outcomes, indications and timing of surgery following rib fracture fixation. Using the Core Outcomes Measures in Effectiveness Trials (COMET) methodology, three expert panels including clinicians, allied health professionals and patients will be invited to participate in an online questionnaire. Consensus will be achieved after three rounds using a rating scale of 1 (not important) to 9 (critically important). Those responses unable to gain consensus will be dropped through subsequent rounds. All three expert panels will take part in the development of a core outcome set. Clinicians will run a concurrent consensus on timing and indications for surgery. Discussion: A consensus on the indications, timing and outcomes that should be measured in a surgical rib fracture fixation trial is required to address in ability to compare multiple studies for evidence synthesis. Ethics and dissemination: Ethics approval has been obtained from the University of York Health Science Research Governance Committee, Health Research Authority (235596) and North West Research Ethics Committee (18/WM/0018). Systematic review is complete, and the consensus rounds will take place between February and June 2018. Protocol version: 2.0. The results of the study will be disseminated in a peer-reviewed journal. Trial registration: This protocol was registered on the COMET website http://www.comet-initiative.org/studies/details/1104.
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Extracorporeal shockwave therapy with a modified peppering technique for knee osteoarthritis: study protocol for a randomized controlled trial p. 7
Huei-Yu Lo, Huan-Jui Yeh, Kun-Dong Ho
DOI:10.4103/2542-4157.233623  
Background and objectives: Extracorporeal shockwave therapy (ESWT) has been shown to promote pain relief and functional improvement in osteoarthritis (OA) patients. We aimed to determine the efficacy of ESWT for knee OA with a modified peppering technique by comparison with sham treatment. Design: A single-center, double-blinded, randomized controlled trial. Methods: This trial will be performed at Taoyuan General Hospital, Taiwan, China. We will enroll at least 36 patients with knee OA (Kellgren-Lawrence grading scale, grade 2 to grade 4) to receive ESWT or sham ESWT. Using simple randomization patients will be assigned into two groups: ESWT and sham ESWT. In the ESWT group, patients will receive 1600 pulses of shockwave at 0.24 mJ/mm2 weekly for 3 weeks. In the sham ESWT group, patients will receive 1600 pulses of shockwave at 0.24 mJ/mm2 in the same area without jelly between applicator pad and handpiece. Outcome measures: The primary outcome measure is Western Ontario and McMaster Universities Osteoarthritis Index. The secondary outcome measures are Visual analog scale and six-minute walk test. The patients will be evaluated at baseline, 3rd week and 4th week. Discussion: The trial outcomes will investigate the effects of ESWT with a modified peppering technique in patients diagnosed with knee OA. Ethics and dissemination: This study protocol has acquired written approval from Ethics Committee, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan, China (IRB No. TYGH105013), and will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association. Written informed consent will be obtained from all participants. The results will be published in peer-reviewed journals or disseminated via conference presentations. Trial registration: ClinicalTrial.gov identifier: NCT03048773; registered on February 9, 2017. Protocol version: 1.0.
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Three different radiological indicators for diagnosis of adult acetabular dysplasia: study protocol for a diagnostic trial and preliminary results p. 12
Di Qin, Xiao-Bo Wu, Hui-Jie Li, Li-Ying He, Tao Wu, Wen-Hui Ma, Shi-Wei Hu, Yong-Tai Han
DOI:10.4103/2542-4157.233633  
Background and objectives: Acetabular dysplasia is often characterized by acetabular bone hyperplasia and osteonecrosis of the femoral head. These pathological changes can alter the position of the center of the femoral head, causing abnormal values on anteroposterior radiographs of the adult pelvis involving the Wiberg anterior center-edge (CE) angle, acetabular angle (Sharp angle), and acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular dysplasia. Herein, we introduce and verify three X-ray indicators, offshoring index (OFI), moving up index (MUI) and teardrop baseline offshoring index (TBOI). All data will be expressed as relative ratios, as we expect to make an accurate diagnosis by avoiding the generation of errors resulting from measurement angles. Design: A single-center, diagnostic trial. Methods: Two hundred adult patients (100 female and 100 male) will be scheduled to undergo pelvic X-ray examinations at the Third Hospital of Hebei Medical University in China. The affected and healthy sides will be measured and analyzed using commercial software. Outcome measures and preliminary results: The primary outcome measure is the sensitivity of OFI of the femoral head for diagnosing adult acetabular dysplasia. Secondary outcome measures include the specificity, positive and negative predictive values, and positive and negative likelihood ratios of OFI, and sensitivity specificity, positive and negative predictive values, and positive and negative likelihood ratios of MUI and TBOI of the femoral head for diagnosing adult acetabular dysplasia as well as the rate of correct diagnosis; correlation of OFI, MUI and TBOI to CE angle, Sharp angle and acetabular head index; and risk factors for hip dysfunction as analyzed by logistic regression analysis. In our pre-tests, pelvic X-ray data from 241 male patients showed that the OFI, MUI and TBOI were 86.8 ± 0.6%, 75.8 ± 2.0% and 76.2 ± 0.5%, which closely correlated with CE angle, Sharp angle, and acetabular head index (AHI). Discussion: This study is designed to verify that three new X-ray indicators, OFI, MUI and TBOI, as diagnostic indicators for adult acetabular dysplasia, can increase diagnostic accuracy and effectively avoid diagnostic errors in comparison with the CE angle, Sharp angle, and AHI. Ethics and dissemination: The study was approved by the Ethics Committee of the Third Hospital of Hebei Medical University in China (approval No. KE2016-011-1). The study will be performed in accordance with the relevant laws and regulations of the Declaration of Helsinki. All the participatns will be fully informed of the study protocol and experimental process, and provide written informed consent with the premise of fully understanding the treatment plan. The results of this study will be disseminated in peer-reviewed journals or presented at scientific meetings. Trial registrations: This trial was registered in the Chinese Clinical Trial Registry with registration number: ChiCTR1800016375 (protocol version: 1.0).
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Stratification of injuries to the lateral collateral ligament of the ankle using ultrasound: protocol of a prospective, open-label, diagnostic trial and preliminary results p. 17
Dan Huang, Xiu-Zhen He, Xu-Huan Yang, Si-Min Peng, Ying-Xian Wu
DOI:10.4103/2542-4157.233637  
Background and objectives: Patients with ankle sprain most commonly experience injuries to the lateral collateral ligament (LCL) complex, which affects the stability and function of the ankle. Early diagnosis of LCL complex injuries is extremely important. In clinical practice, magnetic resonance imaging (MRI) displays the soft tissues of the ankle well, but it is expensive and cannot be used for real-time evaluation. Ultrasound (US) has the advantages of ease of operation, low cost, and real-time capability. Some studies have reported on the stratification of injuries to the LCL complex using US. However, there is controversy regarding the injury grading. The purpose of this study was to investigate the grading of LCL complex injuries (sprain, partial tear, and complete tear) using US. Design: A prospective, open-label, diagnostic trial. Methods: Seventy patients with suspected ankle sprain who have an acute ankle sprain history and present with surgical indicators will be scheduled to receive ankle ligament repair surgery in the Guangzhou Orthopedics Hospital, China. On the day after admission, these patients will undergo US and magnetic resonance imaging (MRI) of the injured ankle prior to ankle ligament repair surgery (test group). The contralateral ankle will be included in the control group and will also undergo MRI and US examination prior to surgery. MRI or surgical results will be used as the gold standard for diagnosing LCL complex injuries. The feasibility of stratification of LCL complex injuries (sprain, partial tear, and complete tear) using US will be evaluated. Outcome measures and preliminary results: The primary outcome measure of this study is the sensitivity of US in the diagnosis of complete LCL complex tear. The secondary outcome measures are the sensitivity of US in the diagnosis of sprain and partial tear of the LCL complex; the specificity, positive predictive value, negative predictive value, accuracy, area under the ROC curve (AUC), and cut-off value of US in the diagnosis of sprain, partial tear, and complete tear of the LCL; and US imaging for the anatomy of the LCL complex. The results of 53 patients with acute ankle sprain included in the preliminary study suggest that there is no significant difference in the type of injuries to the talofibular ligament and calcaneofibular ligament between ultrasound diagnosis results and surgical or MRI findings (P > 0.05). Discussion: The results of this study will reveal whether US has a higher diagnostic value than MRI in the diagnosis of injuries to the LCL complex. Ethics and dissemination: This study was approved by Medical Ethics Committee of Guangzhou Orthopedics Hospital, China in May, 2018 (approval No. 2018-05). This study protocol will be performed in strict accordance with the Declaration of Helsinki. The personal information and data of the testing subjects participating in the clinical trials will be confidential and will be protected in accordance with applicable laws and regulations. The study protocol was designed in February 2018. Patient recruitment will begin in August 2018 and end in August 2019. Data collection will begin in August 2018. Data analysis will be performed in December 2019. The study will end in March 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016244). Protocol version: 1.0.
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