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   2018| January-March  | Volume 3 | Issue 1  
    Online since March 21, 2018

 
 
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RESEARCH ARTICLES
Functional outcomes and health-related quality of life after open repair of rotator cuff tears: a prospective cohort study
Joel Galindo-Avalos, Oscar Medina-Pontaza, Juan López-Valencia, Juan Manuel Gómez-Gómez, Avelino Colin-Vázquez, Rubén Torres-González
January-March 2018, 3(1):1-6
DOI:10.4103/2542-4157.227045  
Background and objectives: Rotator cuff tears are a common cause of shoulder pain, that can diminish a patient’s functionality and quality of life. The objective of this study was to assess the effectiveness of open repair of rotator cuff tears by evaluating functional outcomes and health-related quality of life. Design: A prospective cohort study. Methods: We evaluated the functional outcome and health-related quality of life (HRQoL) of 120 patients with rotator cuff tears, aged 40 to 65 years, repaired by an open technique applying two questionnaires, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) and a shortened form (12 items) of the Short Form 36 Health Survey version 2 (SF12v2) preoperatively, and at 3, 6 and 12 months postoperatively. Functional outcomes were categorized as Excellent (88–100), Good (75–87), Fair (62–74) or Bad (61 or less) depending on the ASES score. The HRQoL was divided into its physical and mental components (physical component summary (PCS) and mental component summary (MCS), respectively) by using QualityMetric Health Outcomes™ version 4.5, and was categorized as under the norm, at the norm, or above the norm. We also evaluated if a relationship existed between sex, side, tear size, or tear pattern, with the functional outcome or the HRQoL. Results: We found a statistically significant difference between the preoperative ASES and PCS scores with the 6- and 12-month follow-up results and between preoperative MCS score with the 12-month follow-up result (P < 0.05). We found no correlation between functional outcome and HRQoL; or between sex, side, tear size, or tear pattern, with the functional outcome and HRQoL (P > 0.05). Conclusion: Open repair of rotator cuff tears remains a valid and effective option, despite the current trend of arthroscopic repair, obtaining satisfactory results at around 6 months after surgery. Trial registration: This study was registered at SIRELCIS, with the identifier R-2011-3401-43 CLIS 3401.
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STUDY PROTOCOL
Effects of balance training prior total knee replacement surgery: study protocol for a randomized controlled trial
José-María Blasco, Fernando Dominguez-Navarro, Celedonia Igual-Camacho, Antonio Silvestre-Muñoz, Sergio Roig-Casasús
January-March 2018, 3(1):12-17
DOI:10.4103/2542-4157.227050  
Background and objectives: Many functional limitations following total knee replacement are related to balance. This trial aims to determine the short and long-term effects on balance and functionality of a preoperative muscle enhancement program that includes a specifically oriented protocol of balance and proprioception training in the methods. Design: Prospective three-arm, randomized controlled trial. Methods: Seventy-eight participants will be will be recruited from Hospital Clínico y Universitario de Valencia in Spain, and randomly divided into three equal groups: a control group, a active comparator which performs a program for muscle enhancement preparatory for surgery, and a experimental group which additionally includes a program oriented to enhance balance and proprioception. Outcome measures: The primary outcome measures are overall balance assessed by the Berg Scale and self-reported functionality measured by the Knee Injury Osteoarthritis Outcome Function Score. Secondary outcomes include stability, dynamic and static balance abilities, anxiety-depression, and knee function. Outcomes will be assessed prior to intervention, 2 weeks, 6 weeks and 1 year after surgery. A cost effectiveness-analysis will be conducted based on the quality adjusted life years gained. Discussion: The results will help to appraise the early-postoperative effects in terms of balance and functionality. This research will also appraise the cost-effectiveness of the proposal, based on data extracted from long-term evaluations. Ethics and dissemination: The trial was approved by the Ethics and Scientific Committee of the Clinical and University Hospital of Valencia (26052016). Early-postoperative outcomes will be likely available by November 2018. Follow-up will be completed by the end of 2019. The results will be disseminated through workshops, peer-reviewed publications, and local and international conferences. Trial registration: ClinicalTrials.gov identifier: NCT02995668.
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RESEARCH ARTICLES
Evaluation of a computer-assisted orthopedic training system for learning knee replacement surgery: a prospective randomized trial
Jie Xu, Deng Li, Bing Xu, Zhi-qing Cai, Ying-bin Zhang, Ruo-fan Ma
January-March 2018, 3(1):7-11
DOI:10.4103/2542-4157.227047  
Background and objectives: As conventional knee replacement training requires bone model, computer-assisted simulation seems to be an attractive alternative. Therefore, we compared the transfer of conventional training for the knee replacement and computer-assisted simulation to surgery in this trial. Design: A prospective randomized trial. Methods: The study was performed in Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. After completing an intensive course in basic theory of total knee arthroplasty (TKA), three groups of 10 participants proceeded with no additional training (control group), 5 hours of conventional training on bone model (model training group) or simulation TKA training on the computer-assisted orthopedic training system (CAOS training group). Participants were evaluated during a TKA based on a bone model at baseline, 1 week and 4 months after training. Results: The CAOS training group performed the procedure significantly better than the other two groups at posttesting (P < 0.05). CAOS training group performing the procedure better than the model training group was identified at retention testing but this did not reach statistical significance. Conclusion: These results indicated that this computer-assisted training system was able to produce the effect of learning TKA skill, and it could provide a training alternative for novices. Meanwhile, it could enhance student learning through increased motivation.
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STUDY PROTOCOL
Total hip arthroplasty via the direct anterior approach versus lateral approach: study protocol for a randomized controlled trial
Dan Viorel Nistor, Sergiu Caterev, Nicolae Ciprian Bota, Dan Osvald Gheorghe Lucaciu, Adrian Todor
January-March 2018, 3(1):18-23
DOI:10.4103/2542-4157.227048  
Background and objectives: Total hip replacement is evolving to be more refined, especially through the development of muscle sparing approaches such as the direct anterior approach (DAA), bone preserving prosthesis, as well as the use of a fast tracking protocol. Despite the rising interest in the DAA, its attribute and benefits as a muscle sparing approach continue to be debated. While some advocates of this procedure report a faster recovery, lower postoperative pain levels and lower dislocation rates, there are some studies describing higher complication rates specific to the approach, longer setup and surgery time, as well as muscle damage similar to classic approaches, especially in complex cases. We aim to establish if the total hip replacement through the DAA results in lower muscle damage, faster recovery and better overall clinical outcomes when compared to the classic lateral approach. Design: This will be a single-center, single surgeon, randomized controlled trial. Methods: Two hundred patients diagnosed with end-stage primary degenerative hip arthritis confirmed on plain radiographs will be randomly assigned to undergo a primary total cementless hip arthroplasty via the direct anterior approach or the lateral approach. The primary goal of this study is to determine if the direct anterior approach is less invasive and if this yields superior clinical outcomes. Outcome measures: The primary outcome is muscle damage assessment using Myoglobin and Troponin as biomarkers. Secondary outcomes include functional outcome measures Oxford Hip Score, Harris Hip Score and quality of life 36-Item Short-Form Health Survey, physical recovery tests, complication rates, postoperative pain levels (daily for the 1st week and weekly for the first 3 months, as well as 6, 12 and 24 months after surgery), rescue medication consumption, prosthesis component positioning evaluated on radiographs, as well as perioperative data (i.e., surgery and setup time, incision length, blood loss, length of hospital stay, time to cessation of walking aids) and other biomarkers for muscle damage and inflammatory responses (i.e., creatine kinase, lactate dehydrogenase, aspartate aminotransferase and C-reactive protein). Discussion: This study represents a pursuit to provide an evidence based enquiry upon the muscle sparing benefits of the total hip replacement via the direct anterior approach relative to the lateral approach. Ethics and dissemination: This study was approved by the University of Medicine and Pharmacy Cluj-Napoca Ethics Committee (517/2015) and it will be performed in accordance with the guidelines of the Declaration of Helsinki. Written informed consent will be obtained from all patients prior to recruitment in this study. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: ClinicalTrial.gov identifier: NCT02719236.
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A new fixation and reconstruction method versus arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee posterior cruciate ligament: study protocol for a non-randomized controlled trial and preliminary results
Guang-dong Chen, Yang Zhang, Yong-jian Ni, Hong-mei Du, Tong-jun Cao, Zhong-lin Shan
January-March 2018, 3(1):24-31
DOI:10.4103/2542-4157.227049  
Background and objectives: Arthroscopic reconstruction for treatment of avulsion fracture at the tibial insertion of the knee posterior cruciate ligament (PCL) can minimize surgical trauma to the largest degree. However, its implants have relatively poor stability; therefore, functional exercise cannot be performed in the early stages after surgery, which is inconducive to knee function recovery. It is extremely challenging to perform traditional open reduction with internal fixation to repair avulsion fractures at the tibial insertion of the knee PCL. Often, the crushed bones cannot be firmly fixed because of their small size, leading to a poor repair effect. Therefore, we designed a new inverted “L”-shaped incision in the popliteal fossa through which bone plates were inserted to fix the crushed bones and to reconstruct PCL tension, facilitating knee function recovery. In this study, we plan to compare the therapeutic effects of this new fixation and reconstruction method, and arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee PCL. Design: A prospective, single-center, non-randomized controlled trial. Methods: One hundred and eighty patients (knees) with avulsion fracture at the tibial insertion of the knee PCL will be assigned to two groups based on treatment methods: arthroscopic reconstruction group (n = 90; fracture fixation and repair under the arthroscope) and new method group (n = 90; bone plates will be inserted through an “L”-shaped incision in the popliteal fossa to fix the crushed bones and reconstruct PCL tension). After surgery, these patients will be followed up for 6 weeks, 6 months, and 12 months. Outcome measures and preliminary results: The primary outcome measure is the excellent and good rate of knee function recovery at 12 months after surgery as evaluated by Lysholm Knee Scoring Scale score (herein referred to as Lysholm score). The secondary outcome measures are the excellent and good rate of knee function recovery before surgery, 6 weeks and 6 months after surgery; Lysholm score before surgery, 6 weeks, 6 months and 12 months after surgery; Hospital for Special Surgery (HSS) knee score, Visual Analogue Scale (VAS) score, posterior drawer test negative rate, X-ray morphology of the knee before surgery, and 6 weeks, 6 months, and 12 months after surgery and; incidence of adverse events at 6 weeks, 6 months and 12 months after surgery. Results of a preliminary study involving 62 patients (knees) with avulsion fracture at the tibial insertion of the knee PCL showed that posterior drawer test negative rate and Lysholm score were significantly higher in the new method group compared to the arthroscopic reconstruction group (P < 0.05) at 3 months after surgery. Discussion: This study will be performed to compare the therapeutic effects of bone plate insertion through an “L”-shaped incision made in the popliteal fossa to fix the crushed bones and to reconstruct PCL tension, and traditional fracture fixation and repair under the arthroscope to treat avulsion fracture at the tibial insertion of the knee PCL. We believe that the former method will be superior to the latter one because it can fix the avulsion fracture more firmly, facilitating knee function recovery. Ethics and dissemination: This study has been approved by Medical Ethics Committee of Cangzhou Central Hospital of China (approval No. 2017-120-01). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Participants will provide signed informed consent prior to participation in the study. This study was designed in December 2017. Patient recruitment and data collection will begin in April 2018. Patient recruitment will end in June 2019. Data analysis will be performed in August 2020. The study will be completed in October 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: ChiCTR1800015026). Protocol version: 1.0.
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MISCELLANEOUS
Information for Authors - Clinical Trials in Orthopedic Disorders (CTOD)

January-March 2018, 3(1):32-36
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