CLINICAL DYNAMICS

Study Name: Clinical efficacy and safety of hip/knee replacement assisted by joint replacement navigation and positioning system for different prostheses
Site: West China Hospital of Sichuan University, The Fourth Medical Center of the PLA General Hospital, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine，The Second Xiangya Hospital, Central South University, The Second Affiliated Hospital of Army Military Medical University，The First Affiliated Hospital of Sun Yat-sen University，Union Hospital Affiliated to Fujian Medical University，The Second Hospital of Lanzhou University，The Second Affiliated Hospital of Harbin Medical University，Shanghai Tongji Hospital，Huazhong University of Science and Technology Union Shenzhen Hospital，Jiangjin Hospital Affiliated to Chongqing University
Target Disease: Osteoarthritis
Study Type: Interventional study
Study Design: Non randomized control
Study Objective: The purpose of this clinical trial was to investigate the compatibility and suitability of the joint replacement navigation and positioning system (YUANHUA) produced by Bone Shengyuan Robot (Shenzhen) Co., LTD., when used in different rostheses, and compare the effectiveness and safety of traditional surgical methods.
Inclusion Criteria: TKA: (1) Age 18-80 years old, gender is not limited; (2) Patients diagnosed with knee osteoarthritis who did not respond to conservative treatment; (3) Patients who were assessed by the investigator to require unilateral first knee replacement surgery; (4) The subjects fully understand the benefits and risks of this experiment and are willing to participate and sign the informed consent. THA: (1) Over 18 years old, gender is not limited; (2) Patients should have indications for hip replacement surgery; (3) Patients voluntarily participate in clinical trials and are willing to sign an informed consent form.
Exclusion Criteria：TKA: (1) Patients with neuromuscular insufficiency (e.g., paralysis, myolysis) that will lead to postoperative dysfunction affecting lower limb function; (2) Patients with severe internal or surgical diseases or weak constitution who cannot tolerate surgery; (3) Charcot's arthritis; (4) There is an active infection in the body (systemic or local infectious lesions); (5) Serious osteoporosis, metabolic bone disease, radiation bone disease, and tumor around the knee joint; (6) Patients expected to have poor compliance; (7) Pregnant or lactating women, or patients who have family planning during the clinical study; (8) Other situations in which the investigator considers it inappropriate to participate in the study. THA: (1) Neuromuscular dysfunction, such as paralysis, myolysis, or abductor weakness which can lead to postoperative hip instability or gait abnormalities in patients; (2) Patients with a history of infection or suspected/confirmed infection in the hip joint or other parts of the body; (3) Known patient has a history of allergies to one or more implanted materials; (4) Patients with severe internal and surgical diseases or weak physical constitution who cannot tolerate surgery; (5) Patients with poor expected compliance; (6) Pregnant or lactating women, or patients who have family planning during the clinical study; (7) Other situations in which the investigator considers it inappropriate to participate in the study.
Group 1: Robot-assisted total knee arthroplasty (rTKA), patients undergoing TKA assisted by joint replacement navigation and positioning system, Sample size 350
Group 2: Traditional manual total knee arthroplasty (mTKA),Patients undergoing traditional manual total knee arthroplasty, Sample size 350
Group 3: Robot-assisted total hip arthroplasty (rTHA),Patients undergoing THA assisted by joint replacement navigation and positioning system, Sample size 350
Group 4: Traditional manual total hip arthroplasty (mTHA),Patients undergoing traditional manual total hip arthroplasty, Sample size 350
Primary Indicator: Hip-knee-ankle, HKA; Accuracy of acetabular cup implantation
Secondary Indicator: Accuracy of prosthesis implantation, KSS, WOMAC, Operation time, Anterior inclination and abduction angle degrees of acetabular cup implantation, The percentage of safe zones for accurate implantation of acetabular cups, Lower limb length accuracy, Harris hip score
Blinding: Blinding evaluators
EC Approval Time: 01 Feb, 2024

Study Name: Research on the Development and Transformation of Drug Gene Diagnostic Kits
Site: The First Affiliated Hospital of Henan University
Sponsor: Shandong Lukang Haoliyou Biotechnology Development Co., Ltd.
HGRAC Approval Time: December 2023

Study Name: Prospective, Single-Center, Exploratory Study Evaluating the Feasibility and Safety of Transcatheter Mitral Valve Replacement System 
Site: West China Hospital of Sichuan University (Sichuan International Hospital)
Sponsor: Shanghai MicroPort CardioFlow Medtech 
HGRAC Approval Time: December 2023

Study Name: Retrospective Performance Review Test of Flow Cytometer and Monoclonal Antibody Reagents Using Peripheral Blood Samples
Site: Kunshan Traditional Chinese Medicine Hospital (Kunshan Branch of Jiangsu Traditional Chinese Medicine Clinical Research Institute)
Sponsor: BD Rapid Diagnostic Products Co, Suzhou
HGRAC Approval Time: December 2023
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.

Study Name: Clinical Trial on the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) for Recurrent Head and Neck Tumors and Primary Brain Malignant Tumors
Site: Xiamen Humanity Hospital
Sponsor: Neuboron Medical, Xiamen
Third-party Lab: Nanjing Clinical Tech Laboratories
HGRAC Approval Time: December 2023

Study Name: Research and System Construction of Early Detection of Gene Methylation in Ovarian Cancer
Site: People's Hospital of Liaocheng City
HGRAC Approval Time: December 2023

Study Name: Research and System Construction of Early Detection of Gene Methylation in Bladder Cancer
Site: People's Hospital of Liaocheng City
Sponsor: BioChain (Beijing) Science & Technology
HGRAC Approval Time: December 2023

Study Name: Research and System Construction of Early Detection of Gene Methylation in Endometrial Cancer
Site: People's Hospital of Liaocheng City
HGRAC Approval Time: December 2023

Study Name: Exploratory Clinical Study of Absorbable Drug-Eluting Vertebral Artery Stent Treatment for Vertebral Artery Stenosis  
Site: Beijing Tiantan Hospital, Capital Medical University
Sponsor: Biotyx Medical, Shenzhen China
HGRAC Approval Time: December 2023

Study Name: Prospective, Single-Center, Exploratory Study Evaluating the Feasibility and Safety of Transcatheter Mitral Valve Replacement System 
Site: Fujian Medical University Union Hospital 
Sponsor: Shanghai MicroPort CardioFlow Medtech 
HGRAC Approval Time: December 2023