Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.The American Knee Association classification system is class A; 5.Male or female, aged 50 to 75 years; 6.Body mass index (BMI) of 18.5-35kg /m^2; 7.Varus knee with tibiofemoral angle =90 degree; 10.Bilateral quadriceps strength of grade 4+ and -5; 11.Thigh circumference of 40-55 cm at 10 cm above the patella.
Exclusion criteria
Exclusion criteria: 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.Incorporate any other medical conditions that may compromise the safety of participants or may affect the results of the study as a result of participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative resting pain in the thigh and surgical site; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serological inflammatory markers and tissue damage markers;Coagulation markers;Western Ontario and McMaster University Osteoarthritis Index;American Knee Association Score;Range of motion of knee joint, degree of contractures on affected side, active flexion of affected knee at non-loading position;Quadriceps strength;Patient satisfaction;Lower limb swelling degree;Incidence of deep vein thrombosis; | — |
Countries
China
Contacts
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine