Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: A multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz
Zhang H.,Peking University |
Zhang K.,Peking University |
Zhang X.,Shanghai 6th Peoples Hospital |
Zhu Z.,Shanghai 9th Peoples Hospital |
And 8 more authors.
Arthritis Research and Therapy | Year: 2015
Introduction: Intra-articular injection of hyaluronic acid (HA) is often used as therapy for knee osteoarthritis because it is less expensive and less aggressive than total knee replacement. Therefore, it is important to document whether HA is safe and efficacious. We tested whether single and multiple injection viscosupplementation with HA is associated with clinically meaningful pain relief in a new randomized clinical trial (RCT). Our objective was to compare safety and efficacy of intra-articular HA in two formulations: one 3.0 ml injection of Durolane versus five 2.5 ml injections of Artz for the treatment of knee osteoarthritis pain. Methods: Patients (N = 349) from the People's Republic of China were randomized to treatment (Durolane = 175, Artz = 174). The Durolane group received a 3.0 ml injection at week 0 (baseline), with sham skin punctures at weeks 1, 2, 3, and 4. The Artz group received one 2.5 ml injection at each of the same time points. The primary assessment tool was the Likert-type Western Ontario and McMaster University (WOMAC) pain scale at weeks 0, 6, 10, 14, 18, and 26. Secondary assessments were WOMAC physical function, knee stiffness, and global self-assessment, at identical time points. Statistically-controlled analyses were non-inferiority of Durolane over 18, then over 26 weeks, with a priori non-inferiority defined as 8% of the relevant scale. Acetaminophen was permitted as rescue analgesia and all adverse events (AEs) were recorded. Results: Overall study retention was excellent; 332 patients (95.1%) completed 18 weeks and 319 (91.4%) completed 26 weeks, with no significant retention difference between treatment arms. All variables met non-inferiority criteria over 18 and 26 weeks. Efficacy response in both arms was >90%. Treatment-related AEs were 9.8% (17/174) for Artz and 13.1% (23/175) for Durolane. Conclusions: A single injection of Durolane is non-inferior to 5 injections of Artz over 18 and 26 weeks for pain, physical function, global self-assessment, and knee stiffness. Both treatments were efficacious, safe, and well tolerated. Trial registration: ClinicalTrials.gov NCT01295580. Registered 11 February 2011. © Zhang et al.; licensee BioMed Central. Source
Qian D.J.,Shandong University |
Guo X.K.,Shandong University |
Guo X.K.,University of Jinan |
Duan H.C.,Shanghai 9th Peoples Hospital |
And 4 more authors.
Experimental Biology and Medicine | Year: 2014
Cell therapy has shown its power to promote diabetic chronic wound healing. However, problems of scar formation and loss of appendages have not yet been solved. Our study aims to explore the potential of using embryonic skin cells (ESkCs) to repair diabetic wounds. Circular wound was created on the back of the diabetic mice, and ESkCs stained with CM-DIL were transplanted into the wound. Wound area was recorded at the day 4, 7, 11, and 14 after transplantation. The tissue samples were obtained at week 1, 2, and 3, and the tissue sections were stained by transforming growth factor β1 (TGF-β1), TGF-β3, vascular endothelial growth factor (VEGF), and CD31. The new skin formed on the wound of the diabetic mice with ESkC treatment at week 1 but not on the wounds of the non-treatment group. The histological scores of diabetic group with ESkC treatment were significantly better than the non-treatment group (P < 0.05). The fluorescence examination of CM-DIL and CD31 staining indicated that the ESkCs participated in the tissue regeneration, hair follicles formation, and angiogenesis. The expression of TGF-β1 and VEGF in ESkC-treated groups was noticeable in week 1 but disappeared in week 2. TGF-β3 was not expressed at week 1 but expressed markedly around hair follicles in week 2 in ESkC-treated groups. Our study demonstrated that ESkCs are capable of developing new skin with appendage restoration to repair the diabetic wounds. © 2014 by the Society for Experimental Biology and Medicine. Source
Wang X.,Shanghai 9th Peoples Hospital |
Lin Y.,Shanghai JiaoTong University |
Yu H.,Shanghai 9th Peoples Hospital |
Cheng A.H.-A.,University of Adelaide |
And 4 more authors.
Journal of Craniofacial Surgery | Year: 2011
BACKGROUND: Fibrous dysplasia is a benign developmental dysplastic disorder of the bone in which abnormal fibroblastic proliferation replaces the normal bone matrix. Craniomaxillofacial fibrous dysplasia can cause severe deformity with devastating functional and aesthetic consequence. Precise surgical removal of the fibro-osseous tissue is the key to ultimately restore normal function and aesthetics. Navigational surgical tool has become a useful adjunct in the surgical management of the craniomaxillofacial skeleton. METHODS: Thirteen patients with facial asymmetry and deformity caused by craniomaxillofacial fibrous dysplasia were enrolled into this study. With preoperative planning and three-dimensional simulation, normal anatomic contours of the deformed area were recreated by superimposing unaffected to the affected side. After registration, surgical facial recontouring was performed under the guidance of navigation system. RESULTS: Good accuracy was achieved with the registration of patient's facial skeleton and preoperative three-dimensional reconstructed model in all the cases. With intraoperative navigational guidance, facial bone recontouring was performed uneventfully in all cases. Surgical accuracy was evaluated by comparing the preoperative and postoperative computed tomography scan measurement. The mean maximum discrepancy between the actual surgical reduction and preoperative planning was less than 2 mm. Symptoms associated with optical nerve compression were eliminated in affected individuals. All patients' facial symmetry and aesthetics were improved. CONCLUSION: Navigation-guided facial bone recontouring is a valuable treatment modality in managing craniomaxillofacial fibrous dysplasia. Copyright © 2011 Mutaz B. Habal, MD. Source
Ding H.,Shanghai 9th Peoples Hospital |
Zhu Z.,Shanghai 9th Peoples Hospital |
Tang T.,Shanghai 9th Peoples Hospital |
Yu D.,Shanghai 9th Peoples Hospital |
And 2 more authors.
Journal of Materials Science: Materials in Medicine | Year: 2012
It is generally accepted that periprosthetic bone resorption is initiated through aseptic inflammation aggravated by wear particles that are generated from artificial joint. However, some studies have demonstrated that "endotoxin-free" wear particles are almost completely unable to stimulate the macrophage-mediated production of proinflammatory cytokines. Here, we compare the titanium particles with different methods of endotoxin removal. The results indicated that different titanium particle preparation dosages did not significantly change particle size, morphology, and chemical composition. But it could cause variations in the endotoxin concentration of titanium particles and inflammatory responses in RAW264.7 macrophages. The particles with higher endotoxin levels correlated with more extensive inflammatory responses. When testing endotoxins using the supernatant of particle suspensions, it would lead to false negative results compared with testing the particle themselves. And when using the particles themselves, all the particles should be removed by centrifugation to avoid particle interference before the absorbance value was determined. Therefore, we suggest that research concerning wear particles should completely describe the endotoxin testing process, including endotoxin removal from particles and the details of endotoxin testing. Moreover, future research should focus on the surface of wear particles (the potential role of adherent endotoxin) rather than the particles themselves. © Springer Science+Business Media, LLC 2012. Source