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COMMENTARIES
Assessing surgical methods for treatment of cubital tunnel syndrome - which is the best?
Karen E Burtt, Ido Badash, Brian Wu
July-September 2017, 2(3):123-124
DOI:10.4103/2542-4157.213700  
Cubital tunnel syndrome is a common and debilitating cause of upper extremity neuropathy. Several surgical options exist for treating this condition, including simple decompression, subcutaneous anterior transposition, and submuscular anterior translocation. The literature shows no clear differences in outcomes of these procedures. Consequently, the decision of which procedure to perform is often a matter of surgeon preference. Liu et al. has designed a blinded, randomized clinical trial to compare outcomes at 6 months postoperatively. This commentary addresses strengths and potential areas of improvement in the study protocol. With revision, the aforementioned study could provide clinical value in determining the ideal surgical option for cubital tunnel syndrome that maximizes reduction of symptoms while minimizing complications.
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REVIEWS
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.
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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.
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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.
  2 1,614 199
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.
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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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Clinicopathological characterization of long bone non-union: a prospective cross-sectional study
Avelino Colin-Vazquez, Luis Dario Bernal-Fortich, Joel Galindo-Avalos, Juan López-Valencia, Rafael Grajales-Ruiz, Adrián Miguel-Pérez, Jorge Quiroz-Williams, Elizabeth Pérez-Hernández
October-December 2018, 3(4):101-106
DOI:10.4103/2542-4157.248607  
Background and objectives: The exact biological process that leads to a non-union remains obscure and it is well accepted that any intervention to reverse this process must be timely and well directed to re-establish both biological and mechanical deficiencies. The purpose of the present work was to identify the possible morphological patterns of bone tissue in a state of non-union and in the presence or absence of infection. Methods: A prospective, observational, cross-sectional study was performed. Bone tissue samples obtained from patients with radiologically and clinically diagnosed long bone non-union undergoing revision surgery were included, without distinction of age and sex. Histopathological analysis and semiquantitative evaluation of tissue samples were performed using conventional optical microscopy. Clinical data related to the study variables were obtained, such as type of consolidation, time of evolution, and corresponding bacteriological analysis. Results: Several morphological pattern variables such as bone quality, osteosclerosis, areas of bone devitalization, osteoclastic activity, vascularization, and in particular cell density were related to the subtype of long bone non-union. They were also associated with septic and aseptic variants of long bone non-union. Conclusion: The biological bone profiles, in particular the histomorphological characteristics, are related to the subtype of non-union and reflect the physiopathological environment that involves an anabolic and catabolic imbalance. These can be incorporated into the classification system and favor the stratification of non-union. Ethics and trial registration: This study was approved by Comité Local de Investigación y Ética en Investigación en Salud at UMAE “Dr. Victorio de la Fuente Narváez” (R-2017-3401-8) on July 19, 2017 and registered with SIRELCIS (identifier: R-2017-3401-8).
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Efficacy of arthroscopic surgery for discoid lateral meniscus injury in knee joint: a self-control study
Jian-Jun Mai, Bin Xu, Jun Tu, Lei Wu
October-December 2018, 3(4):89-96
DOI:10.4103/2542-4157.248605  
Background and objectives: Discoid meniscus injury is a rare form of abnormal meniscus morphology with unknown pathogenesis. The complete disc-shaped meniscus is more prone than incomplete disc-shaped meniscus to tearing and adverse reactions such as joint degeneration and osteochondritis. Moreover, its clinical efficacy is not satisfactory. Arthroscopic meniscus surgery can enhance the stability of the meniscus and provide sufficient cushioning pressure to prevent recurrent meniscal tears. Therefore, this study will investigate the efficacy of arthroscopic surgery for discoid meniscus injury in knee joint and analyze risk factors that influence the efficacy of arthroscopic surgery. Methods: This single-center, self-control study will include 196 patients with discoid meniscus injury who will receive arthroscopic meniscus repair (Stryker) from December 2018 to December 2019 at the Department of Sports Trauma and Arthroscopy, First Affiliated Hospital of Anhui Medical University of China. This surgical procedure will include meniscus plasty and subtotal meniscectomy. After surgery, all included patients will be followed up for 6–18 months. Surgical efficacy will be evaluated by Lysholm score. Patients will be divided into an excellent-and-good group (Lysholm score ≥ 85) and a poor group (Lysholm score < 85). Results: The primary outcome measure of this study is the change in excellent-and-good rate of Lysholm score that reflects knee joint function measured at the last follow-up in patients undergoing arthroscopic meniscus surgery. Secondary outcome measures are Lysholm score; Outerbridge grade of chondral lesion; knee joint morphology by magnetic resonance images before surgery and at the last follow-up; age, sex, lesion region, and course of disease before surgery; and incidence of adverse reactions at the last follow-up. Clinical data from 115 patients with discoid meniscus injury (150 knees) who received treatment from April 2015 to September 2016 were retrospectively analyzed. Six to eighteen months of follow-up of 115 patients revealed a significant difference in Lysholm scores before surgery (65.80 ± 9.39) and at the last follow-up (89.15 ± 7.45; P < 0.05). Postoperative Lysholm scores were excellent in 32 patients, good in 61 patients, fair in 18 patients, and poor in four patients, with an excellent-and-good rate of 80.9%. Knee joint infection did not occur in any patient. There were four patients with lateral interstitial pain and two patients with lateral instability of the knee joint. Logistic regression analysis revealed that course of disease, age, and Outerbridge grade of chondral lesion were risk factors that influenced the efficacy of arthroscopic meniscus surgery. Conclusion: Results from this study hope to confirm that arthroscopic surgery for discoid meniscus injury is a definitive treatment technique. Patient age and the degree of chondral lesion are closely related with efficacy, so it is recommended that patients with symptomatic discoid meniscus injury undergo surgery as soon as possible. Ethics and trial registration: This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Anhui Medical University (approval No. PJ2018-02-03) on February 5, 2018. The version of the study protocol is 1.0. Patients and their family members will volunteer to participate in this study. Written informed consent will be obtained from each patient. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800019182) on October 30, 2018.
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Polyetheretherketone cages used in anterior cervical discectomy and fusion surgery: a meta-analysis
Sukrit Sharma, Shakti Amar Goel, Sunil Sharma, Harvinder Singh Chhabra
April-June 2019, 4(2):29-33
DOI:10.4103/2542-4157.259629  
Background and objective: In the current clinical scenario, a wide variety of fusion techniques are being used along with polyetheretherketone (PEEK) cages in anterior cervical discectomy and fusion surgeries. Some of these techniques involve use of autografts, allografts, biomaterials or only PEEK cages. In this study, the existing literatures for anterior cervical discectomy fusion surgeries using PEEK cages and their outcomes have been reviewed to evaluate the results for the best possible alternative. Materials and methods: A PubMed search for all papers stating “PEEK cages used in cervical spinal fusion,” “PEEK materials used in cervical spinal fusion,” and “artificial materials used in cervical fusion surgery with PEEK cages” was done for all studies before January 2018. A total of 197 studies were found, of which 15 were shortlisted as per the inclusion criteria. The existing literatures on PEEK cages used in spinal surgeries were reviewed and analyzed. Statistical analysis was done using SPSS software version 25.0 and Student’s t-test was used to compare the results. Results: The total number of patients involved in the existing study was 767 with a mean age of 51.67 ± 9.01 years. 191 patients (24.9%) had cervical radiculopathy or myelopathy; 35 patients (4.5%) had cervical degenerative diseases; 29 patients (3.78%) had cervical spine injury with monosegmental instability; and the rest of the patients suffered from other disorders. The level of surgery for patients was single in 429 patients (55.93%) and multiple in 338 patients (44.06%). PEEK plus bone grafts had a significantly better fusion rate compared with PEEK plus artificial materials (95% confidence interval: 91.075 ± 2.09%; P = 0.0035) for multiple-level anterior cervical discectomy and fusion surgery. Conclusion: PEEK plus bone grafts showed a significant fusion rate compared with PEEK plus artificial materials. PEEK plus bone grafts is a better filler material as compared to PEEK plus artificial materials in anterior cervical discectomy and fusion surgeries for multiple levels involved.
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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.
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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 1,792 216
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 1,756 179
Efficacy of silver needle acupuncture combined with muscle relaxation in the treatment of capulohumeral periarthritis: study protocol for a prospective, single-center, randomized, parallel-controlled trial
Jun-Min Yu, Jun-Jie Yu, Hui-Hui Cai, Chuan-Sheng Liu, Yan-Wei Yin, Feng-He Xu, Yu-Sheng Yi, Chao Meng
October-December 2018, 3(4):120-126
DOI:10.4103/2542-4157.248610  
Background and objectives: Muscle relaxation therapy comprising general anesthesia and an intra-articular injection of betamethasone is commonly used to treat capulohumeral periarthritis. This treatment quickly improves the limited motion of the shoulder joint and restores the shoulder to its functional position, but cannot effectively inhibit the inflammatory response. Aseptic inflammatory pain can reportedly be relieved by silver needle acupuncture. However, there is insufficient high-quality evidence to validate the efficacy of silver needle acupuncture in the treatment of capulohumeral periarthritis. Therefore, the proposed study aims to evaluate the efficacy of silver needle acupuncture combined with muscle relaxation therapy in the treatment of capulohumeral periarthritis. Design: A prospective, single-center, open-label, randomized, parallel-controlled trial. Methods: Sixty patients with capulohumeral periarthritis will be assigned to receive either silver needle acupuncture plus muscle relaxation therapy (n = 30) or muscle relaxation therapy alone (n = 30). Patients will be followed up at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment. Outcome measures: The primary outcome measure is a Visual Analog Scale score obtained at 3 days post-treatment. The secondary outcome measures are: the Visual Analog Scale scores before treatment and at 14 days, and 1, 3, 6, and 12 months post-treatment; the Shoulder Joint Activity Function Rating Scale (Melle scale) score, American Shoulder and Elbow Surgeons Standardized Shoulder score, McGill Pain Questionnaire score, University of California at Los Angeles shoulder score before treatment and at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment; 12-item Short-Form Health Survey score at 1, 3, 6, and 12 months post-treatment; and the incidence of adverse events at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment. Conclusion: The study results will provide evidence indicating whether silver needle acupuncture plus muscle relaxation is more effective than muscle relaxation alone in the treatment of capulohumeral periarthritis. We hypothesize that silver needle acupuncture plus muscle relaxation not only improves shoulder joint function, but also reduces inflammatory pain in the shoulder joint. Ethics and dissemination: This study was approved by the Medical Ethics Committee of the Affiliated Hospital of Qingdao University of China on June 25, 2018 (approval No. QDDXFSYY-LL-06-25). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Written informed consent regarding the study protocol and surgery procedure will be obtained from each participant. This study was designed in June 2018. Patient recruitment and data collection began in September 2018 and patient recruitment will end in April 2019. Result analysis will be performed in May 2020. This study will be scheduled to end in June 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016706). Study protocol version: 1.0.
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Comparing unicompartmental to total knee arthroplasty in medial gonarthritis: study protocol for 2-year follow-up of a randomized controlled trial
Carl Aulin, Nicolas Martinez-Carranza, Johan Fyhrlund, Hans E Berg, Margareta Hedström
July-September 2018, 3(3):74-80
DOI:10.4103/2542-4157.233632  
Background and objectives: Since the 1990s, unicompartmental knee arthroplasty (UKA) are again starting to gain interest worldwide. A mere 3.5% of all knee arthroplasties performed in Sweden 2014 were UKAs, whereas up to 25% had knee osteoarthritis isolated to the medial side. Reasons for this discrepancy might be that UKAs are considered more technically demanding, thus requiring more surgical training, and that long-term survival of these implants has been inferior compared to total knee arthroplasty (TKA). This has been addressed by improving surgical instruments and discontinuation of underperforming implants, and by improving surgical technique including mini-invasive incision and patient selection. In support of using the less surgically invasive UKA, a few cohort studies show less pain, fewer hospital days, and faster rehabilitation. However, to the best of our knowledge, there is a lack of high quality randomized clinical trials (RCTs) showing unequivocal clinical superiority of UKA compared to TKA. The aim of the present study is to compare changes in muscle mass, strength, performance based measures (PBMs), and patient reported outcome measures (PROMs) in patients randomized to UKA or TKA. Design: A 2-year follow-up RCT. Methods: The study will include 80 patients with medial knee osteoarthritis, aged 50 years or more, who will be scheduled for a knee replacement and equally randomized to either TKA or UKA. Outcome measures: The primary outcome is muscle mass change at 6 weeks, 6, 12 and 24 months post-operatively measured by computed tomography. Secondary outcomes are PBMs, PROMs, muscle strength, and 3D motion analysis at the same occasions. Discussion: Although patients subjected to total hip arthroplasty are typically satisfied with their surgical results, patients with TKA are less so. It is of importance to improve surgical procedure, and less invasive surgery of the knee might be a solution. Ethics and dissemination: The study has been approved by the Regional Ethics Committee in Stockholm (DNR: 2014/1895-31/3) and will be conducted in accordance with the ethical principles of the Declaration of Helsinki. All patients will sign a consent form after being given oral and written information of the study. Patient recruitment began in November 2015 and will end in December 2019. Data collection will complete in June 2021. We plan to present results in open access scientific publications and at scientific conferences and meetings. Trial registration: The study protocol was registered with ClinicalTrials.gov (identifier: NCT 02563756) on September 18, 2015. Protocol version: 1.0.
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