Traditional Chinese Medicine manipulation for tourniquet-related injuries after total knee arthroplasty:A prospective randomized controlled study

The First Teaching Hospital of Tianjin University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Participant is willing and able to give informed consent for participation in the trial;
•2. Participant is willing and able to comply with all trial requirements;
•3. Patients with end-stage knee OA requiring unilateral TKA;
•4. Graded as A, according to the AKS scoring system;
•5. Male or female, aged 50-75 years;
•6. Body mass index (BMI) of 18.5-35kg /m2;
•7. Varus knee with tibiofemoral angle =15°;
•8. Flexion contracture =15° without genu recurvatum in both knees;
•9. Active ROF =90° in both knees in a non-weight-bearing position;
•10.Bilateral quadriceps strength of grade 4+- 5;
•11. Thigh circumference of 40-55 cm at 10 cm above the patella.

•1. A participant with histories of fracture or surgical procedure on the affected lower limb.
•2. With history of infection on the affected knee;
•3. With obvious bone defect in the distal femur or proximal tibia of the affected side;
•4.With bone deformity or ligament insufficiency around the affected knee;
•5. With obvious joint effusion in the affected knee;
•6.With any disorder that may affect the movement of the ankle, knee or hip, cause pain in the lower extremities, or affect lower limb function;
•7.With cognitive impairment, severe acute/chronic mental illness, anxiety or depression;
•8.With tumor, Parkinson's disease, rheumatoid arthritis, other immune or inflammatory diseases.
•9.With severe osteoporosis;
•10. With immunosuppressive status or history of immunosuppressive use;
•11. With hemorrhagic diseases, coagulopathy or history of thrombotic disease
•12. With severe hypertension, arhythmia or other cardio-cerebro vascular disease;
•13. With history of receiving acupuncture, sodium hyaluronate or corticosteroid injection, or any other invasive treatment within 1 year;
•14.With history of receiving massage or manipulation, or participating in other clinical studies that may affect the results of this study within 3 months;
•15. With any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the results of the trial.

发起方

The First Teaching Hospital of Tianjin University of TCM