ABSTRACT
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.
ABSTRACT
BACKGROUND:Absorbable bio-glass injection composed by bio-glass and calcium phosphate bone cement can be tightly combined with bone tissue by a strong chemical bond to improve the stability of the bone-implant interface. OBJECTIVE:To investigate the effect of absorbable bio-glass injection to support the vertebral body of osteoporosis mice and its mechanism of osteogenic induction. METHODS:Osteoporosis models were prepared in 30 female Sprague-Dawley rats undergoing bilateral ovariectomy. After modeling, model rats were randomly divided into three groups, and given polymethylmethacrylate, injectable calcium phosphate bone cement and absorbable bio-glass injection into L3-5 vertebral bone defects, respectively. L3-5 segments were removed at 12 weeks after implantation to detect the biomechanical and degradation properties, levels of calcium and phosphate, alkaline phosphatase activity, bone mineral density, levels of bone morphogenetic protein 2 and transforming growth factor β, as wel as histological observation. RESULTS AND CONCLUSION: In the absorbable bio-glass injection group, the degradation properties, compressive strength, surface hydroxyapatite deposition amount and bone mineral density were significantly higher than those in the other two groups(P< 0.05); trabecular bone relative volume, thickness and number were significant higher than those in the other two groups (P < 0.05); serum levels of calcium, alkaline phosphatase, bone morphogenetic protein 2 and transforming growth factor β were significantly higher than those in the other two groups(P < 0.05); but the level of serum phosphate was lower than that in the other two groups(P < 0.05). These results show that the absorbable bio-glass injection can enhance the support for the osteoporotic vertebral body and induce osteogenesis, probably by increasing bone morphogenetic protein 2 and transforming growth factor β levels.
ABSTRACT
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.