Background: Rotator cuff tear is one of the most common diseases in orthopedics, which seriously affects the quality of patients’ lives. And the arthroscopic repair of rotator cuff has recently become more and more popular. Systematic rehabilitation makes great significance for improving the prognosis of postoperative patients. Yet, the traditional outpatient rehabilitation is hard to popularize in developing countries like China due to the limitation of traffic and geography. Given this, we plan to develop a telerehabilitation system to facilitate doctors' remote guidance on patients' rehabilitation.Methods/design: Our study is a single-center, prospective randomized controlled trial. 124 patients who underwent arthroscopic rotator cuff repair will be recruited for the study. They will be randomly divided into 2 groups (62 cases in each group) based on the stratification factors of the operator, operation and preoperative diagnosis. The patients in the control group will get clinic and booklet based rehabilitation treatment after operation. However, patients in the experimental group will receive mobile phone and motion-capture device based programs for telerehabilitation after surgery. The primary outcome will be measured by the American Shoulder and Elbow Surgeons (ASES). Secondary outcomes include the Range of motion (ROM), Visual Analogue Scales (VAS), EuroQol-5 Dimension health questionnaire (EQ-5D), University of California at Los Angeles(UCLA)and the retear rate.Discussion: We hypothesize that patients who utilized mobile phone and motion-capture device based telerehabilitation will benefit more in the range of motion and shoulder function than those who received outpatient and manual based rehabilitation. If the hypothesize was confirmed, we could facilitate telerehabilitation for doctors and overcome the geographical and traffic limitations of traditional clinical based rehabilitation.Trial registration: ChiCTR.org.cn, ChiCTR2000030150, Registered on 24 February 2020
Background: Hemophilia A (HA) is an X-linked monogenic disorder caused by deficiency of the factor VIII (FVIII, F8) gene in the intrinsic coagulation cascade. The current protein replacement therapy (PRT) of HA has many limitations including short term effectiveness, high cost, and life-time treatment requirement. Gene therapy has become a promising treatment for HA. Orthotopic functional F8 biosynthesis is critical to its coagulation activities. Methods: To investigate targeted F8 expression, we developed a series of advanced lentiviral vectors (LVs) carrying either a universal promoter (EF1α) or a variety of tissue-specific promoters, including endothelial-specific (VEC), endothelial and epithelial-specific (KDR), and megakaryocyte-specific (Gp and ITGA) promoters. Results: To examine tissue specificity, the expression of a B-domain deleted human F8 (F8BDD) gene was tested in human endothelial and megakaryocytic cell lines. Functional assays demonstrated F8 activities of LV-VEC-F8BDD and LV-ITGA-F8BDD in the therapeutic range in transduced endothelial and megakaryocytic cells, respectively. In F8 knockout mice (F8 KO mice F8null mice), intravenous (iv) injection of LVs illustrated different degrees of phenotypic correction as well as anti-F8 immune response for the different vectors. The iv delivery of LV-VEC-F8BDD and LV-Gp-F8BDD achieved 80% and 15% therapeutic F8 activities over 180 days, respectively. Different from the other LV constructs, the LV-VEC-F8BDD displayed a low F8 inhibitory response in the treated F8null mice. Conclusions: The LV-VEC-F8BDD exhibited high LV packaging and delivery efficiencies, with endothelial specificity and low immunogenicity in the F8null mice, thus has a great potential for clinical applications.
Chronic granulomatous disease (CGD) is a congenital immunodeficiency characterized by lack of reactive oxygen species in phagocytes. We developed an in vivo gene therapy strategy based on intravenous (iv) injection of lentiviral vectors (LVs) in X-CGD mice. A non-myeloablative chemo-conditioning regimen using busulfan, cyclophosphamide and dexamethasone was developed to improve iv LV gene delivery efficiency. The X-CGD mice received two LVs injections. After the second injection, antibody response to LV particle-associated p24-protein was examined by Western blot. We detected increased gene transfer without anti-p24 antibody response. However, the blood vector copy number (VCN) was gradually reduced after 3–12 months. To improve gene delivery into hematopoietic stem cells (HSCs), the mice were treated with AMD3100 to mobilize HSCs before LV injection. To confirm HSCs gene transfer, we transplanted the HSCs from the LV-CYBB-treated CGD mice into untreated CGD mice. The result showed successful passage of LV-CYBB HSCs to recipient mice. Thus, by combining chemo-conditioning and AMD3100 mobilization prior to the iv LV injection, improved in vivo long-term LV gene transfer into HSCs could be established. This improved iv LV gene delivery strategy could reduce both the risk and the cost of CGD gene therapy with great potential in translational applications.
Background: Lower limb dysplasia is a rare complication after interventional closure of patent ductus arteriosus (PDA) in childhood. The most common treatment of PDA is interventional closure via femoral artery. Compared with traditional surgery, its advantages include less trauma and faster postoperative recovery, but the complications after interventional occlusion should not be ignored. Case presentation: A 10-year-old girl had redness and swelling of the toes of the right lower limb with skin ulceration on the medial side of the right foot for more than 4 months. She accepted interventional closure of PDA 7 years ago. Physical examination showed that the right foot was about 2 cm shorter than the left foot. We present a rare case of a young girl with lower limb dysplasia after interventional closure of PDA in childhood, Combined findings of Color Doppler ultrasound, Intravenous Ultrasound (IVUS), Computed tomography angiography (CTA) and Angiography, we found right foot developmental delay most likely was due to vascular injury after interventional closure of PDA in childhood. Conclusion: It is critical to understand not only the acute but also the long-term complications that may occur after interventional procedure. To avoid the development of vascular injury, it is advised that patients who underwent femoral artery catheterization for interventional treatment in their early years undergo strict clinical and imaging surveillance.
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