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BACKGROUND:Total knee arthroplasty is the main treatment for end-stage knee disease.However,knee prostheses are mostly imported from overseas,making the price expensive.Furthermore,ethnic differences mean that these prostheses designed for westerners are not designed to meet the needs of Orientals.OBJECTIVE:To verify the efficacy and safety of this novel knee prosthesis in total knee arthroplasty.METHODS:We propose to conduct a prospective,single-center,randomized,positive parallel controlled,non-inferiority,clinical trial at Shiyan Taihe Hospital,China.Seventy-two patients with knee disease who are scheduled to undergo knee arthroplasty will be equally randomized into the trial group or the control group using a randomized block design.The trial and control groups will undergo knee arthroplasty with knee prostheses purchased from Wuhan Yijiabao Biomaterial Co.,Ltd.,Wuhan,China (newly developed) and Beijing AKEC Medical Co.,Ltd.,Beijing,China (approved by the China Food and Drug Administration),respectively.All patients will be followed up for 12 months.The primary outcome will be the recovery of knee function as assessed by the rate of excellent and good Hospital for Special Surgery knee scores at postoperative 12 months (± 15 days).The secondary outcomes will be:the morphology of the knee as revealed by anteroposterior and lateral radiographic views taken preoperatively,and at postoperative 2 weeks (± 5 days),6 weeks (± 15 days),3 months (± 15 days),6 months (± 15 days),and 12 months (± 15 days);the incidence of adverse reactions at postoperative 2 weeks (± 5 days),6 weeks (± 15 days),3 months (± 15 days),6 months (± 15 days),and 12 months (± 15 days);and the correlation between various types of adverse reactions and each knee prosthesis type.This trial has been registered at ClinicalTrials.gov (identifier:03184129).The study protocol has been approved by the Ethics Committee of Taihe Hospital of China (approval number:2016 (34)).All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki.Written informed consent was provided by each patient and their family members after they indicated that they fully understood the treatment plan.DISCUSSION:Participant recruitment began in February 2017 and will be finished in September 2017.Data analysis will be completed in November 2018.Wuhan Yijiabao Biomaterial Co.,Ltd.has developed a new knee prosthesis system.This system uses cobalt-chrome-molybdenum and high cross-linked polyethylene as the active friction interface,which has excellent wear resistance.This trial is designed to verify the efficacy and safety of this novel knee prosthesis in total knee arthroplasty.
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Objective: To evaluate the clinical efficacy and side effects of icotinib combined with a subarachnoid space implantable pump for the treatment of leptomeningeal metastases (LM) from lung adenocarcinoma. Methods:Seven cases of LM from lung adeno-carcinoma with epidermal growth factor receptor mutation were included in the study from March 2011 to September 2015. With the aid of anesthetists, all patients were implanted with subarachnoid space implantable pumps to drain the cerebrospinal fluid (CSF) and then treated with icotinib (125 mg, three times a day) until disease progression or unacceptable toxicities. After 4 weeks, the efficacy and tolerability of icotinib were evaluated on the basis of symptoms, tumor markers from CSF, and brain gadolinium-enhanced magnet-ic resonance imaging scans. Results:Among the seven patients evaluated, no patient had complete response, two patients had partial response, four had stable disease, and one had progression. The patient who was progressive died at a month after therapy. The sur-vival time of all the other patients was more than 4 months. The common adverse effects of icotinib were skin rash and diarrhea, main-ly in grades 1 and 2. No infection of the local subarachnoid drainage tube was found in the abdominal wall. Conclusion:Icotinib com-bined with a subarachnoid space implantable pump for the treatment of LM from lung adenocarcinoma may be effective, and the tox-icities are tolerable. This method could also obviously alleviate the clinical symptoms and improve the quality of life of the patients, worthy of further study.
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Objective To evaluate the clinical results of indirect reduction and fixation with the self-manufactured external fixator as a viable alternative in the surgical treatment of intraarticular calcaneal fractures.Methods From May 2006 to May 2009,a total of 30 patients undergone surgical treatment of intraarticular calcaneal fractures were analyzed,including 20 males and 10 females with an average age of 36 years (range,15-53).According to Sanders classification based on the computed tomography scan of intraarticular calcaneal fractures,16 patients were classified as type-Ⅲ,and 14 type-Ⅳ in this series.All fractures were treated first with the external fixator as indirect reduction and fixation device on the whole,which can enlarge the interspace of the subtalar joint significantly.Then,posterior articular facet of calcaneus was exposed and reduced through a small lateral incision.The calcaneal's length,breadth,thalamus height,maximum vertical displacement of the post-articular surface,and B(o)hler angle were measured preoperatively,3 days and 6 months after operation in X-ray film.Reduction results were evaluated by CT scan according to the standard of Buckley.Results The average follow-up time of all patients was 29 months (range,4-45).Lateral and axial roentgenograms showed satisfactory restoration of the calcaneal's anatomical structure.There were significant differences between preoperative values and those 3 days or 6 months postoperatively.There were no significant differences between values 3 days postoperatively and those 6 months postoperatively.The reduction results of posterior articular facet were evaluated by CT scan.Twenty-seven patients obtained anatomical reduction,3 patients obtained uneven articular facet within 2 mm.Conclusion This selfmanufactured external fixator is a vialbe alternative in the treatment of intraarticular calcaneal fractures,which has advantages of minimal invasion,practicality and less complications.
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<p><b>BACKGROUND</b>To investigate the efficacy of EP regimen combined with split-course hyperfractionated accelerated irradiation for locally advanced non-small cell lung cancer.</p><p><b>METHODS</b>The treatment was composed of 3 cycles of combined chemoradiotherapy at 4-week intervals. Chemotherapy with cisplatin ( 30 mg/m²) and etoposide (60 mg/m²) was administrated intravenously on days 1-3, followed by radiotherapy on days 4-8. A course of radiotherapy consisted of 1.5 Gy per fraction, twice a day (3 Gy per day) for 5 consecutive days, for a total dose of 15 Gy. In the third cycle, additional irradiotherapy consisted of 2 Gy once a day was performed on days 11-15, for a total dose up to 55 Gy during 10 weeks. After three cycles, patients were given 2 additional cycles of chemotherapy with MVP regimen.</p><p><b>RESULTS</b>Of the 43 patients, 12 had a complete remission and 22 a partial response, resulting in an overall response rate of 79.1%. Of the 152 chemotherapeutic cycles administrated, there were 40 during which grade III-IV toxicities occurred, mainly consisting of leukopenia and vomiting. The 1- and 2-year survival rates were 66.7% and 57.2%, respectively.</p><p><b>CONCLUSIONS</b>EP regimen combined with split-course hyperfractionated accelerated irradiation is effective and well tolerated for advanced locally non-small celll lung cancer. It should be investigated further.</p>