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RESEARCH ARTICLES
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.
  10,933 227 1
Surgical site infections in orthopedic surgery: incidence and risk factors at an Iranian teaching hospital
Keykhosro Mardanpour, Mahtab Rahbar, Sourena Mardanpour, Nyousha Mardanpour
October-December 2017, 2(4):132-137
DOI:10.4103/2542-4157.219372  
Background and objectives: Surgical site infection (SSI) is rare complication in orthopedic surgery and have serious consequences for outcomes and costs. Different risk factors may be involved, including age, sex, body mass index (BMI), prophylactic antibiotics, operation technique and duration, type of shaving, and length of hospitalization. This study aimed to determine the risk factors affecting orthopedic surgical site infections and their incidence at Imam Reza and Taleghani , two major referral teaching hospitals in west of Iran. Design: A prospective cohort study. Methods: A 36-month prospective cohort study, with 1 to 12 months of patient follow-up after surgery, was conducted at the teaching hospital in Iran. Patients (n = 1,900) who had undergone orthopedic surgery were studied between January 2012 and January 2015. Each patient was followed by pre- and post-operative examinations and telephone follow-ups. Results: Of the 1,900 patients, 73 suffered from SSI (3.84%). Methicillin Resistant Staphylococcus aureus (MRSA) 53% (n = 25) and Staphylococcus coagulase-negative 32% (n = 15) are the most common isolated germs. The smoking, high BMI, multiple fractures, increased operation time, increased bed stay, electivity of the operation, type of operation, using prosthetic implant and pre-operation of prophylactic antibiotic were all significantly associated with increased evidence of SSI (P < 0.04). Conclusion: Our study presented that stopping smoking, appropriate pre- and post-operational antibiotic prophylaxis regimens specially when using prosthetic implant, shortening duration of surgery and hospitalization and experience of the surgeon should be helpful to reduce rate of SSI.
  3,807 357 -
REVIEWS
Venous thromboembolism in the setting of orthopedic trauma surgery
Ido Badash, Emily G Pott, Brian W Wu
October-December 2016, 1(4):128-137
DOI:10.4103/2542-4157.194812  
Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, can result in serious medical complications and is the leading cause of preventable hospital deaths. Risk of VTE is especially concerning in orthopedic trauma, where VTE incidences of up to 80% can result in significant morbidity following surgery. Studies investigating VTE in orthopedic trauma have identified predisposing factors for VTE that can be used to stratify patients for risk of developing thrombosis. Additionally, an assortment of diagnostic procedures may be used to reliably detect or exclude VTE, and various methods of VTE prophylaxis has been shown to reduce patient morbidity and mortality. However, many orthopedic trauma patients who present with known risk factors still do not receive the prophylaxis they need, and hospital resources may be misused when inappropriate diagnostic tests are ordered. As a result, it is critical for physicians working in orthopedic trauma to be aware of validated methods for VTE management, including known risk factors, diagnostic tools, and prophylactic methods, to appropriately and efficiently manage VTE. The purpose of this review is to centralize information about the management of VTE in orthopedic trauma. Articles included were selected from leading journals and online databases based on their scientific merit and applicability to clinical orthopedics. By consolidating information about VTE management, it will be possible to identify areas that need further research and ultimately create guidelines that standardize the treatment of VTE in orthopedic trauma across multiple institutions.
  2,631 865 1
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.
  3,015 344 -
STUDY PROTOCOL
Isometric muscle strength as a predictor of one repetition maximum in healthy adult females: a crossover trial
Manisha Parai, Pramod Divakara Shenoy, Shalini Velayutham, Choo Kian Seng, Charmaine Yip Fung Yee
April-June 2016, 1(2):71-78
DOI:10.4103/2468-5674.183005  
One repetition maximum (1RM) and maximum voluntary contraction (MVC) with a digital dynamometer are popular methods of measuring muscle strength. The types of muscle contraction involved in both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with a digital dynamometer involves isometric muscle contraction (IMMC). There are several risks involved in measurement of 1RM, such as delayed onset muscle soreness and being unsafe for pathological joints, all of these can be reduced if we use IMMC in measuring muscular strength. Both cannot be equated as they are different types of contraction, therefore the purpose of this study was to compare and find a relationship between 1RM measurement and isometric MVC in healthy females. Twenty-nine young females (mean age = 20.77 ± 1.28 years) without any weight training experience (mean body mass index = 20.43 ± 1.85) volunteered to participate in the study. It was a crossover trial where 48 hours of rest period was given between each measurement technique. Results showed moderate correlations (r = 0.365-0.847) between 1RM and MVC. A simple linear regression analysis revealed a significant estimated regression equation for dominant and non-dominant sides [dominant, Y = 0.391X + 1.472; non-dominant, Y = 0.251X + 2.629 (Y: 1RM, X: Isometric)] with low standard error of estimate (dominant, 0.74; non-dominant, 0.80). Results also showed no significant difference between these derived equations and Brzycki 1RM prediction equation. Both prediction equations can be used interchangeably to predict the muscle strength of a healthy female, and thus IMMC can be used to predict 1RM in healthy females.
  2,687 310 -
REVIEWS
Preemptive analgesia in orthopedic surgery: a literature review
Juan Lopez Valencia, Anapaola Koch Leopo
October-December 2017, 2(4):144-152
DOI:10.4103/2542-4157.219377  
Pain after surgery is a maladaptive response. Acute postoperative pain is an important predictive factor for chronic post-surgical pain, which is observed in 10–65% of patients after surgery. Therefore controlling pain after surgery is very important. Reducing postoperative pain will result in more patient satisfaction, less complications due to immobility and decreased hospitalization periods. In this review, the use of preemptive analgesia in orthopedic surgery with a great variety of medications and interventions is examined. A search with the key words of “preemptive analgesia”, “orthopedic surgery” and “post-surgical pain” was conducted in online database PubMed, EBSCO, Elsevier (ClinicalKey), SpringerLink and OVID. Then selected articles from 5 years relevant with the application of preemptive analgesia in orthopedic surgery were analyzed. Finally we show some interventions with the outcomes and the challenges and new investigations suggested. The results showed that preemptive analgesia can be from regional blockade and local wound infiltration before incision to application of oral or intravenous medication before beginning surgery (NSAIDs, Gabapentin, Pregabalin, Dextromethorphan, Melatonin, Multimodal and Opioids) and the new approaches like transcutaneous electrical nerve stimulation (TENS). Preemptive analgesia has an important role in diminishing the pain rate in the post-surgical state, lowering pain medication intake and improving the patient satisfaction and early mobilization.
  2,493 308 -
Recent advancements in magnesium implants for orthopedic application and associated infections
Jaslin P James
October-December 2016, 1(4):138-144
DOI:10.4103/2542-4157.194813  
In recent years extensive research on magnesium and its alloys as potential biodegradable implant materials have been carried out by various research groups around the world. Biodegradable magnesium alloys are more suitable for load-bearing implant applications than their polymeric counterparts because of their superior mechanical strength. Moreover, since their elastic properties resemble those of natural bone, they are considered ideal for hard tissue implants employed in fracture stabilization so that stress shielding is avoided and bone regeneration is enhanced. Also studies have shown that Mg alloy exhibit good biocompatibility with no systemic inflammatory reaction or affection of the cellular blood composition. One of the main advantages of biodegradable implants is the elimination of follow-up surgery to remove the implant after the tissue has healed sufficiently. Consequently, extensive studies have been carried out to develop Mg-based alloys with superior mechanical and corrosion performance. This review focuses on the following topics: (i) the design criteria of biodegradable materials; (ii) in vitro performances of currently developed magnesium alloys; (iii) improving properties of Mg based orthopedic implants using surface improvement techniques and other alloying methods; as well as (iv) implant infections and current methods.
  2,405 321 2
STUDY PROTOCOL
A corrective functional exercise program for postural thoracic kyphosis in teenagers: study protocol for a randomized, controlled clinical trial
Qiang Feng, Yu Zhou, Mei Wang, Yan-feng Zhang, Fubaihui Wang
October-December 2016, 1(4):158-163
DOI:10.4103/2542-4157.194805  
Background: In this report, we describe our protocol for testing the hypothesis that a comprehensive corrective training program for teenagers could effectively treat postural thoracic kyphosis, which is a common problem in this age group. Methods/Design: This was a prospective, single-center, randomized, controlled, open-label trial completed at the China Institute of Sport Science in Beijing, China. Eighty teenagers were enrolled and randomized into two groups (n = 40/group). The participants completed one of two training programs: 1) a comprehensive training program aimed at functional correction of posture that targeted active range of motion, proprioception, and strength of the muscles acting on the cervical, thoracic, and lumbar vertebrae (test group) or 2) a standard strength-training program (control group). The two training programs were designed to be equal in intensity and each consisted of two 20-minute sessions per week for 8 consecutive weeks. All participants underwent non-invasive testing using Spinal Mouse® while standing upright, and with their trunks in flexion and extension, before, and at 1, 2, and 4 weeks after the final training session. Outcome measures were assessed before training and 1, 2, and 4 weeks after the last training session. The primary outcome was thoracic kyphosis angle. Secondary outcomes included lumbar lordosis, sacral inclination angle, thoracic inclination angle, range of motion of the spine, posture, and the incidence of adverse events. Discussion: Successful treatment of postural thoracic kyphosis would improve the health of affected teenagers. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (www.chictr.org.cn) (registration number: ChiCTR-INR-16008860). Ethics: This trial has been approved by the Ethics Committee of the China Institute of Sport Science, Beijing, China and performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Training content and process was fully exposed to all the participants, and signed informed consent was obtained from each participant.
  2,287 260 -
ORIGINAL ARTICLES
Traction apophysitis of the medial malleolus
Sandeep Kumar Nema, Gopisankar Balaji, P Pasupathy, N Ravi
July-September 2016, 1(3):123-125
DOI:10.4103/2468-5674.189517  
Traction apophysitis of the accessory ossification center of the medial malleolus is infrequently reported. Traction apophysitis of both the accessory ossification centers of medial malleoli is very rare. This entity is also reported as osteochondrosis of medial malleolus in literature. We present a case of traction apophysitis of accessory ossification centers of both the medial malleoli in an 11-year-old boy of Indian origin, who presented with pain and swelling over both the ankle with plano-valgus deformity of feet. His imaging revealed fragmented accessory ossification center of medial malleoli on both the sides. He was treated non-operatively and followed through one year to see the eventual fate.
  2,196 196 -
STUDY PROTOCOL
Safety and efficacy of WeChat combined with Yi Jin Jing exercise for the treatment of cervical spondylosis in white-collar workers: study protocol for a prospective open label randomized controlled trial
Guang-hui An, Xiao-ting Tang, Guo-miao Zhu
January-March 2016, 1(1):31-37
DOI:10.4103/2468-5674.178853  
Background: Yi Jin Jing (changing tendon exercise) is a traditional Chinese exercise. Yi Jin Jing can reportedly prevent cervical spondylosis in financial professionals. In the absence of effective supervision and follow-up training, Yi Jin Jing self-exercise does not become habitual, reducing the efficacy of the technique. WeChat is an online text and voice messaging communication service developed by Tencent in China, and can be used as an interactive platform for doctors and patients. We hypothesized that WeChat could be used to guide Yi Jin Jing exercise, potentially enhancing the preventative and therapeutic benefits for cervical spondylosis in white-collar workers. Methods/Design: 120 financial professionals with cervical spondylosis working at the Bank Card Industrial Park in Pudong New Area, Shanghai, China will be enrolled in this prospective, open label, randomized controlled trial. Participants will be equally and randomly divided into two groups. In the intervention group, participants will undertake conventional Yi Jin Jing training followed by a group chat using WeChat to provide interactive guidance. In the control group, participants will undertake conventional Yi Jin Jing training alone. The primary ontcome will be the Cervical Spondylosis Symptoms scale measured 1, 3, 6 and 12 months after training. The secondary outcomes will be the 36-item Short Form Health Survey score, Visual Analog Scale score for pain intensity, medical expenses and the number of days absent from work. Discussion: This study will examine whether on-going interactive Yi Jin Jing exercise using the WeChat platform will improve outcomes in participants with cervical spondylosis. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-OCH-13003426) on 6 August 2013. Ethical approval: Written approval for this project was obtained from the Ethics Committee of Wanggang Community Health Center, Shanghai Pudong New Area, Shanghai, China (approval number WG2013 0709001). All patients will be informed of the protocols and will provide written informed consent.
  2,122 239 -
RESEARCH ARTICLES
Predicting necrotic femoral head collapse using computed tomographic and X-ray imaging before hip arthroplasty: study protocol and results of a single-center, open-label, diagnostic trial
Di Qin, Wen-hui Ma, Wei-xia Bai, Yong-wei Shang, Hui-jie Li, Yong-tai Han
October-December 2017, 2(4):125-131
DOI:10.4103/2542-4157.219373  
Background and objectives: Determining whether the femoral head collapses and the degree of collapse of the articular cartilage of the femoral head can help select the best surgical treatment plan for patients with osteonecrosis of the femoral head. Currently, articular cartilage collapse > 2 mm or < 2 mm supports palliative surgery and hip arthroplasty, respectively. However, the ideal method to preoperatively predict femoral head collapse remains controversial. We hypothesized that computed tomography (CT) and X-ray imaging can effectively predict collapse of the necrotic femoral head before hip arthroplasty. Our preoperative measurements highly matched measurements of the intraoperatively-resected femoral head specimens. Design: A single-center, open-label, diagnostic trial. Methods: We proposed, and subsequently conducted, a single-center, open-label, diagnostic trial at the Third Hospital, Hebei Medical University, China. Eighty-six patients with unilateral osteonecrosis of the femoral head who underwent total hip arthroplasty were randomized into three groups. In the X-ray group, changes in femoral head height were measured on anteroposterior X-ray images of the pelvis (healthy and affected sides of the hip) at preoperative week 1. In the CT group, changes in femoral head height were measured using bilateral hip CT scans (healthy side and affected side) at preoperative week 1. In the specimen group, the femoral head on the affected side was resected surgically and measured directly with a ruler and vernier caliper. The primary outcome of the trial was the sensitivity of the three methods to detect femoral head collapse. The secondary outcomes were specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and diagnostic accuracy of the three methods to detect femoral head collapse; the consistency of X-ray and CT scans to diagnosis femoral head collapse; changes in the height of the middle, medial, and lateral femoral head measured by the three methods; and morphological changes in the femoral head observed by the three methods. Results: Changes in the height of the femoral head detected by different methods: The heights of the middle, medial and lateral femoral head were not significantly different on the affected side (P > 0.05). Discussion: This trial analyzed femoral head height using X-ray, CT, ruler and vernier caliper to precisely predict collapse of the necrotic femoral head, and provides imaging guidance for clinicians to select the best surgical management for osteonecrosis of the femoral head. Trial registration: ClinicalTrials.gov identifier: NCT03351153.
  1,430 804 -
STUDY PROTOCOL
Treatment of intertrochanteric femoral fracture with proximal femoral medial sustainable intramedullary nails: study protocol for a randomized controlled trial
Peng-bin Yin, An-hua Long, Jing Shen, Pei-fu Tang
April-June 2016, 1(2):44-50
DOI:10.4103/2468-5674.183001  
Background: Conservative management of intertrochanteric femoral fracture often yields poor therapeutic outcomes, and surgical fixation is generally warranted. Biomechanical instability of intertrochanteric femoral fracture is a major cause of fixation failure. To increase the stability of intramedullary nails in intertrochanteric femoral fracture, it is critical to strengthen the support between the nail and the cortical bone. Our previously designed proximal femoral medial sustainable intramedullary nail has been proven to be able to provide this internal support and stabilization by finite element analysis. We aim to examine the efficacy and safety of internal fixation with this new type of intramedullary nail in the treatment of stable and unstable intertrochanteric femoral fractures. Methods/Design: This will be a single-center, two-arm, parallel, randomized controlled trial conducted at the Chinese PLA General Hospital, China. Seventy-two patients with stable or unstable intertrochanteric femoral fracture diagnosed according to AO/OTA Classification of Fractures and Dislocations will be randomly assigned to receive internal fixation either with proximal femoral medial sustainable intramedullary nails, or proximal femoral nail antirotation. The primary outcome measure will be bone healing condition 6 months postoperatively; secondary outcomes will be requirement for revision surgery, quality of life and complications 1 year postoperatively. Discussion: Our findings will provide an evidence base for the use of proximal femoral medial sustainable intramedullary nails for the treatment of intertrochanteric femoral fracture. Trial registration: ClinicalTrial.gov identifier: NCT01437176; registered on 1 September 2011. Ethics: This protocol was approved by Ethics Committee of Chinese PLA General Hospital of China (approval No. 07/06/2011) and will be performed in accordance with the Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent will be obtained prior to involvement in the clinical trial.
  1,955 235 2
REVIEWS
Use of incisional negative pressure wound therapy in orthopedics
Supriya Singh, Jennifer C Urquhart, Christopher S Bailey, Parham Rasoulinejad
October-December 2017, 2(4):153-159
DOI:10.4103/2542-4157.219376  
This review article summarizes the results of currently available literature on use of incisional negative pressure wound therapy for primary closure of orthopedic incisions. Post-operative wound complications place a heavy toll on patients and the health care system. Patients with post-operative wound complications often require readmission, repeat surgery, prolonged hospitalization, and diminished outcomes. The financial burden on the health care system for surgical site infection, the most common post-operative wound complication, varies from $27,969 to over $100,000 per patient, representing a nearly 300% increase in health care costs.The role of incisional negative pressure wound therapy is currently being investigated in reducing post-operative wound complications. However, the subject is still novel and based on our literature search, only 11 papers discuss the role of incisional negative pressure wound therapy in orthopedic surgery, with only one paper providing level 1 evidence. However, despite the paucity of sufficient clinical trials, it appears that most reports suggest positive outcomes with use of negative pressure wound therapy.
  1,839 225 -
STUDY PROTOCOL
Clinical efficacy of tranexamic acid administration via different routes during total hip arthroplasty: study protocol for a prospective randomized controlled trial
Kai-di Zhou, Hong-yi Wang, Yu-fei Yan, Wei-xiang Hong, Jian-min Feng
January-March 2016, 1(1):1-7
DOI:10.4103/2468-5674.178819  
Background: Intravenous injection or topical application of tranexamic acid during total hip arthroplasty has been shown to effectively reduce blood loss. There is no consensus on differences in clinical efficacy and safety between these two administration methods. To determine the optimal clinical efficacy of tranexamic acid during hip replacement, we will compare differences between these two administration methods during total hip arthroplasty. Methods/Design: The study protocol is a prospective, paired (1:1:1), double-blind, randomized controlled clinical trial. A total of 174 patients who will receive hip replacement at Ruijin Hospital, Shanghai Jiao Tong University, China will be randomly divided into three groups, with 58 patients per group. Before the end of surgery, in the placebo group, 60 mL of physiological saline will be used to soak the articular cavity for at least 3 minutes and then be sucked away; in the topical tranexamic acid group, 60 mL of physiological saline containing 3 g tranexamic acid will be used and then sucked away; in the intravenous tranexamic acid group, 100 mL of physiological saline containing 10 mg/kg tranexamic acid will be intravenously administered 15 minutes before surgery and then again 3 hours later. The primary outcome is total blood loss on postoperative day 3, which is calculated using Nadler's and Gross's formula. Secondary outcomes include blood transfusion rates, drainage output within 2 days postoperation, amount of human serum albumin used during hospitalization, postoperative blood coagulation indices, and incidences of deep venous thrombosis and other thromboembolic events during postoperative day 1-week 6. Discussion: This protocol is powered to provide reference information for the rational use of tranexamic acid by comparing clinical efficacy of the drug between intravenous and topical administration routes. Trial registration: ClinicalTrials.gov identifier: NCT02312440; registered on 28 November 2014. Ethical approval: This study protocol was approved by the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University, China (permission No. (2014)-47-2) and will be performed in accordance with the Declaration of Helsinki.
  1,829 225 1
Safety and effectiveness of proximal femoral nail antirotation for the treatment of intertrochanteric femoral fracture: study protocol for a prospective case series
Jun-jie Xu
July-September 2016, 1(3):90-99
DOI:10.4103/2468-5674.189505  
Background: The root cause of intertrochanteric femoral fracture in elderly patients is osteoporosis manifested by reduced bone strength, decreased bone mineral density, and subsequently decreased anchoring between the internal fixator and bone. This is also a major cause of ineffective internal fixation and leads to surgical failure. Because of the special anatomical structure and biomechanical requirements of the proximal femur, internal fixation must have two basic functions, to prevent inversion and rotation of the proximal fractured femur. Reducing the incidence of coxa vara is also one of the treatment objectives. Methods/Design: This is a single-center, prospective, self-controlled case series. The objective of this study is to validate the safety and effectiveness of minimally invasive proximal femoral nail antirotation (PFNA) in the treatment of intertrochanteric femoral fracture. Twenty patients with intertrochanteric femoral fracture scheduled to undergo PFNA implantation will be recruited from the Department of Orthopedics, Chaohu Hospital of Anhui Medical University, China. The primary outcome measure of this study is the percentage of patients having PFNA implantation-related safety problems manifested as pain in the affected region, wound nonunion, incisional infection, and gross findings observed at the time of nail removal, including inflammatory reaction, tissue proliferation, and the appearance of a fibrous capsule wall 3 and 6 months after PFNA implantation. The secondary outcome measures are operative time, intraoperative blood loss, duration of intraoperative fluoroscopy, patients' quality of life evaluated by the EuroQol five-dimension questionnaire and the Barthel Index of Activities of Daily Living, fracture healing examined by X-ray images, and hip joint function evaluated by Harris hip scores 3 and 6 months after PFNA implantation. Discussion: The currently reported clinical studies on PFNA for the treatment of intertrochanteric femoral fracture are mainly case series, a few of which are retrospective, randomized, controlled trials. Here, we will perform a normalized prospective case series to validate the safety and effectiveness of PFNA in the treatment of intertrochanteric femoral fracture. Trial registration: ClinicalTrial.gov identifier: NCT02880501; registered on 18 August 2016. Ethics: This trial has been approved by Ethics Committee, Chaohu Hospital of Anhui Medical University, China and will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from the patients or their relatives.
  1,786 256 -
Femoral nerve block prevents deep venous thrombosis of the lower extremity after knee arthroplasty: a single-center randomized controlled trial
Yi Chen, Shen Qu, Gang Ma, Jin-hai Meng, Xin-li Ni
January-March 2016, 1(1):8-14
DOI:10.4103/2468-5674.178820  
Background: The use of tourniquets in knee arthroplasty can promote the release of abundant neutrophil elastase from neutrophils, which increases the risk of deep venous thrombosis of the lower extremity. Advanced femoral nerve blocks can decrease the risk of deep venous thrombosis of the lower extremity after knee arthroplasty, but their mechanism of action remains unclear. We assume that the femoral nerve block can effectively suppress the inflammatory reaction and prevent deep venous thrombosis of the lower extremity after knee arthroplasty. Methods/Design: A total of 120 patients undergoing total knee arthroplasty under general anesthesia in the General Hospital of Ningxia Medical University of China will be enrolled in this single-center randomized controlled trial. These patients will be equally and randomly assigned to three groups. In the advanced femoral nerve block group, ultrasound-guided femoral nerve block will be conducted 30 minutes before surgery. In the conventional femoral nerve block group, ultrasound-guided femoral nerve block will be carried out at consciousness after surgery. In the intravenous analgesia group, an analgesia pump will be used to relieve pain after surgery. The primary outcomes will be the changes in the levels of serum thrombosis-related inflammatory factors (neutrophil elastase, thrombin-antithrombin III complex, D-dimers, C-reactive protein, tumor necrosis factor-α, interleukin-1, interleukin-6, and interleukin-8) immediately after entering the operating room; 30 and 60 minutes after application of the tourniquet; 30 minutes after removal of the tourniquet; and 12, 24 and 48 hours after surgery. The secondary outcomes measures will be the Ramsay Sedation Scale score, visual analogue scale score, times until initial and complete effect of the block, muscle strength rating, blood loss, and color Doppler ultrasound examination results of the lower extremity veins. Discussion: We hope to identify the clinical advantages of advanced femoral nerve block for total knee arthroplasty and determine whether deep venous thrombosis of the lower extremity after knee arthroplasty can be prevented by inhibiting the release of abundant neutrophil elastase and suppressing the inflammatory reaction. Trial registration: ClinicalTrial.gov identifier: NCT02411097; registered on 20 March 2015. Ethical approval: Written approval for this project was obtained from the Ethics Committee of the General Hospital of Ningxia Medical University of China. All patients or their family members will be informed of the protocols and will provide written informed consent. Our study is in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.
  1,852 189 -
Cubital tunnel syndrome treated with ulnar nerve simple decompression, anterior intramuscular or subcutaneous transposition: a parallel randomized controlled clinical trial
Qian-qian Liu, Rui Li
January-March 2016, 1(1):15-21
DOI:10.4103/2468-5674.178845  
Background: Simple decompression and anterior transposition of the ulnar nerve are surgical methods commonly used for treating moderate and severe cubital tunnel syndrome. It is generally thought that anterior transposition effectively eliminates ulnar nerve compression, but simple decompression cannot improve symptoms. However, studies have also shown that the therapeutic effects of the two procedures are identical. The advantages and disadvantages of the two surgical methods have been described in a small number of cases. Thus, we will conduct a parallel-group randomized controlled clinical trial to determine the optimal surgical intervention. Methods/Design: The trial will be conducted at the Center for Hand and Foot Surgery and Reparative and Reconstructive Surgery, Orthopedics Hospital, the Second Hospital, Jilin University, China. Moderate and severe cubital tunnel syndrome patients will be equally and randomly divided into simple decompression, anterior intramuscular transposition, and anterior subcutaneous transposition groups. In the simple decompression group, adhesions will be completely removed around the ulnar nerve. In the anterior intramuscular transposition group, the ulnar nerve and its accompanying nutrient vessels will be removed in the tunnel of the forearm flexor, pronator teres muscle membrane, and a small portion of muscle fibers below it. In the anterior subcutaneous transposition group, the ulnar nerve in the cubital tunnel will be dissociated and placed in the subcutaneous tissue of the forearm flexor and pronator teres. Two primary outcomes will be determined, sensory disturbance, tested with Semmes-Weinstein filaments, and muscle strength, evaluated using the Medical Research Council's grading system. The secondary outcomes of pain will be assessed with the Visual Analogue Scale and the function of the ulnar nerve with electromyography. Discussion: Trial results will provide a reference for selecting an effective surgical method for treating moderate and severe cubital tunnel syndrome. Trial registration: ClinicalTrial.gov identifier: NCT01893164; registered on 2 July 2013. Ethical approval: Written approval for this project was obtained from the Ethics Committee of the Orthopedics Hospital, the Second Hospital, Jilin University of China. Our study is in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.
  1,815 192 -
Iodophor-impregnated versus iodophor-free adhesive drapes for prevention and healing of wound infections after total hip arthroplasty: study protocol for a randomized controlled trial
Zhuo Wu, Zhi Wang, Zeng-bing Xia
January-March 2016, 1(1):38-43
DOI:10.4103/2468-5674.178854  
Background: Surgical adhesive drapes can be used to create an aseptic area around the operative wound to reduce bacterial infection. However, the efficacy of such drapes in preventing wound infection remains unclear. Few studies have examined the effects of iodophor-impregnated and iodophor-free adhesive drapes on bacteria in the deeper layers of the epidermis. We therefore plan to compare the effects of 3M iodophor-impregnated antibacterial adhesive drapes and 3M aseptic iodophor-free adhesive drapes on the incidence of wound infection and wound healing after total hip arthroplasty. Methods/Design: We will perform a single-center, randomized, double-blinded, parallel-cohort controlled trial at the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China. A total of 120 patients scheduled for total hip arthroplasty will be numbered according to their sequence of admission to the operating room and sex, in a single-blinded manner: men, nos. 1-60 and women, nos. 1-60. Odd-numbered patients will be operated on using iodophor-impregnated adhesive drapes, and even-numbered with iodophor-free adhesive drapes at the surgical site. Peri-articular tissue will be harvested for bacterial culture after disinfection and again between the end of surgery and prior to skin suturing. The primary outcomes will be Bacterial culture results, wound healing time and grade, The secondary outcomes will be pain score (Visual Analog Scale), Harris score, and X-ray results. Discussion: The trial outcomes will support the rational use of iodophor-impregnated surgical adhesive drapes for preventing wound infections after total hip arthroplasty. Trial registration: ClinicalTrial.gov identifier: NCT02707302. Ethical approval: This study protocol acquired written approval from Ethics Committee of Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China (approval No. 2016-001-01), and will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association.
  1,796 188 1
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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ORIGINAL ARTICLES
How well do lower femoral neck shaft angled stems match patients with coxa vara hip deformities?
Omar Alnachoukati, Roger Emerson, Kwame Ennin, Alex Vidal
July-September 2017, 2(3):91-96
DOI:10.4103/2542-4157.213686  
Background and objectives: Patients undergoing total hip arthroplasty (THA) may have femoral deformities classified as either coxa vara, coxa valga, or physiologic. Understanding patients' anatomies is of importance for surgeons in an effort to tailor not only surgical approach, but also implant selection, and ultimately ensure optimal outcomes. The goal of the present study is to determine the efficacy of implanting a lower neck shaft angle (NSA) femoral stem in patients with coxa vara deformities and determine short-term clinical outcomes. Design: A retrospective chart review study. Methods: The study took place at The Texas Center for Joint Replacement in Plano, Texas. Two patient groups, clinical outcomes group and EOS group, were used for this study. The clinical outcomes group contained 55 patients who had undergone primary THA surgery from June 2013 to June 2015 by the senior author. The EOS group contained 36 patients who had undergone primary THA, and completed both preoperative and postoperative biplanar X-rays (low dose imaging device EOS) to obtain three-dimensional reconstructions of the skeletal system from October 2015 to November 2016. Operations were performed in all hips through the anterior supine intermuscular approach utilizing a 123° NSA femoral stem, which was lower than the NSA (133°) found in standard femoral stem implants. Outcome measures: Pre- and postoperative Harris hip scores used to assess clinical outcomes following surgery. Pre- and postoperative femoral offset, NSA, and femur length determined by EOS. Results: In the EOS group, mean femoral offset decreased by 3.5 mm, from 41.08 mm preoperatively to 37.6 mm postoperatively. Mean femoral NSAs decreased by 0.02°, from 123.02° preoperatively to 123.00° postoperatively. Mean femur length decreased by 2.4mm, from 404.2 mm preoperatively to 401.8 mm postoperatively. In the clinical outcomes group, mean Harris hip scores rose from 47 preoperatively to 93 postoperatively. Hip flexion range of motion improved from 87.5° preoperatively to 98° postoperatively. Conclusion: The lower NSA femoral stem examined in this study was proven to accurately restore NSA by 0.03°, femoral offset by 3.47 mm, and femur length by 2 mm, all within clinically documented satisfactory ranges without no revisions, suggesting excellent clinical outcomes in patients with coxa vara hip deformities. THA surgeons may consider utilizing femoral stems with a lower NSA in an effort to adequately restore hip function in patients with coxa vara hip deformities. Trial registration: This is a retrospective chart review study, therefore registration was not required.
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STUDY PROTOCOL
Minimally invasive treatment of proximal humerus fractures with locking compression plate improves shoulder function in older patients: study protocol for a prospective randomized controlled trial
Tao Wu, Guo-qiu Zhang
April-June 2016, 1(2):51-57
DOI:10.4103/2468-5674.183002  
Background: Manual reduction or traditional steel plate fixation is commonly used for repair of proximal humerus factures in older patients, making these injuries prone to fracture malunion because of poor stability. While open reduction with steel plate fixation has a better outcome than closed reduction, the stability of internal fixation is still less than satisfactory. Therefore, we hypothesize that use of a locking compression plate will provide better stability and that biocompatibility will potentiate fracture healing and shoulder function recovery in older patients with proximal humerus fractures. This hypothesis is based on the fact that minimally invasive treatment with locking compression plates has presented good clinical results in terms of fixation stability, bone healing, and functional recovery. Methods/Design: This prospective, single-center, randomized controlled clinical trial will be completed at the Department of Joint Surgery, Affiliated Hospital of Qinghai University in China. Eighty-two older patients with proximal humerus fractures will be enrolled and equivalently assigned to two groups. In the test group, patients will undergo closed reduction via a lateral approach to the shoulder followed by locking compression plate fixation using a minimally invasive technique, and those in the control group will be subjected to closed reduction via a lateral approach to the shoulder followed by conventional steel plate fixation using a minimally invasive technique. All patients will be followed up for 6 months. The primary outcome will be recovery of shoulder function as indicated by clinical outcome scores according to the Neer classification system for proximal humeral fractures 6 months after surgery. The secondary outcomes will include the operation time; intraoperative blood loss; postoperative hospital stay; fracture healing time; clinical outcome scores according to the Neer classification system 0.5, 1, and 3 months after surgery; Visual Analogue Scale scores 1 and 3 days and 1 and 2 weeks after surgery to assess pain; scores of the Medical Outcomes Study 36-item Short Form Health Survey 0.5, 1, 3, and 6 months after surgery to assess quality of life; and X-ray examinations 0.5, 1, 3, and 6 months after surgery to assess fracture healing. Discussion: This study protocol represents an attempt to objectively choose appropriate methods for internal fixation of proximal humerus fractures in older patients by comparing locking compression plate with conventional steel plate fixation to improve shoulder function. Trial registration: ClinicalTrial.gov identifier: NCT02784522. Ethics: This study acquired written approval from the Ethics Committee of the Affiliated Hospital of Qinghai University in China (approval No. QHY1005D); this study 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 prior to involvement in the clinical trial.
  1,640 208 2
Local application of mitomycin C for prevention of epidural fibrosis: study protocol for a prospective randomized controlled double-blinded trial
Tao Sui, Lei Liu, Xiao-tao Wu, Xiao-jian Cao
January-March 2016, 1(1):22-30
DOI:10.4103/2468-5674.178847  
Background: Interventions including lumbar discectomy are a primary treatment method for degenerative disc disease. However, after surgery, scar adhesion often forms at the spinal dura mater or adventitial nerves in the defective vertebral plate region and affects recovery. Our previous animal experiments showed that mitomycin C applied topically could safely protect against epidural fibrosis at an optimal dose of 0.5 mg/mL. However, randomized controlled clinical studies have shown that 1 mg/mL mitomycin C does not show obvious therapeutic effects on epidural fibrosis in patients after lumbar discectomy. Methods/Design: This prospective, randomized, controlled, double-blinded, single-center clinical trial will be performed at the Affiliated Zhongda Hospital of Southeast University in China. Seventy-five patients with single-level lumbar disc protrusion will be included in this study and undergo microendoscopic discectomy. The site of discectomy will be topically treated with cotton wool impregnated with 0.5 mg/mL mitomycin C (treatment group) or 0.9% physiological saline (control group) for 5 minutes. Contrast-enhanced MRI score of the lumbar spine will be the primary outcome measure used to evaluate epidural scar proliferation and adhesion, and Lumbar Spine Outcomes Questionnaire score will be the secondary outcome used to evaluate epidural fibrosis-related clinical symptoms. Discussion: This study protocol will try to establish an imaging method to precisely grade epidural fibrosis data acquired after microendoscopic discectomy via a prospective, randomized, controlled, double-blinded trial. A safe and effective mitomycin C dose, 0.5 mg/mL, will be topically applied, and the efficacy and safety of mitomycin C for the prevention of epidural fibrosis will be investigated to provide evidence for the clinical use of mitomycin C. Trial registration: This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-10001079) on 6 September 2010. Ethical approval: The study protocol has acquired written approval from Ethics Committee of the First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University, China (approval No. 2010-SR-088) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.
  1,661 154 -
Lateral dislocation of the elbow: a report of two cases and literature review
Ganesh Singh Dharmshaktu, Aanshu Singhal
April-June 2016, 1(2):79-82
DOI:10.4103/2468-5674.183006  
Elbow dislocation is the most common dislocation, but most elbow dislocations are posterolateral or posterior. Pure lateral elbow dislocation is rare and often under recognized. It is necessary to assess the radiographic status and clinical features for diagnosis and appropriate management of pure lateral elbow dislocation. The position of the affected extremity at the time of injury and the characteristics and impact of forces over the injured part determine the pattern and direction of subluxation/dislocation of the elbow. We reported two adult cases of lateral elbow dislocation who received closed reduction, splinting and supervised physiotherapy. Lateral ligament complex injury was also managed conservatively. Good functional outcomes with evident limitation of movement were obtained during the follow-up period. No residual instability or re-dislocation was noted.
  1,598 149 -
Minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for repair of distal radius fracture: study protocol for a randomized controlled trial
Zhi Li
April-June 2016, 1(2):58-63
DOI:10.4103/2468-5674.183003  
Background: Conventional open reduction internal fixation and external fixation are not ideal treatment options for distal radius fracture. Minimally invasive surgery for distal radius fracture results in less trauma than other techniques; fully threaded headless cannulated compression screws can increase the stability of fracture fragments and contribute to functional recovery after wrist fracture. In this proposed study, we hypothesize that minimally invasive closed reduction and internal fixation of distal radius fracture with fully threaded headless cannulated compression screws will promote functional recovery of the wrist joint. Methods/Design: In this prospective, randomized, controlled trial, we will recruit 60 outpatients with distal radius fracture from the Department of Orthopedic Surgery, Central Hospital Affiliated to Shenyang Medical College, China. Patients will be assigned to one of two treatment groups: C-arm fluoroscopy-assisted minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws (experimental group) or open reduction (palmar and dorsal incisions) and internal fixation with titanium plate (control group). Internal fixation will be maintained for 24 weeks in both groups. Our primary outcome measures will be X-ray and CT examinations 24 weeks after surgery. Secondary outcome measures include patient-rated wrist evaluation scores, used to evaluate wrist joint function; fracture healing time; and Visual Analogue Scale score, used to evaluate the severity of the patient's pain. Discussion: With this study we hope to confirm that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for distal radius fracture repair has advantages over conventional open reduction internal fixation with titanium plates, providing superior fragment stability and allowing for early rehabilitation exercise of the wrist joint, which improves recovery of function. We hope to show that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws is the more suitable surgical method for repair of distal radius fracture. Trial registration: ClinicalTrial.gov identifier: NCT02784678. Ethics: The study protocol was approved by the Ethics Committee of Central Hospital Affiliated to Shenyang Medical College, China. The trial protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Prior to the trial, patients and their family members will be informed of the risks and benefits of this trial. Signed informed consent will be obtained from each patient.
  1,518 158 2
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.
  1,521 140 -