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

Not Applicable

• Conditions: Knee osteoarthritis

• Registration Number: ITMCTR2100005325
• Lead Sponsor: The First Teaching Hospital of Tianjin University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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. 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.

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. 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative resting pain in the thigh and surgical site;

Secondary Outcome Measures

Name	Time	Method
Incidence of deep vein thrombosis;Coagulation markers: fibrinogen and D-dimer;Range of motion, flexion contracture, non-weight-bearing active flexion, and intraoperative anti-gravity natural flexion immediately after closing the joint capsule;Serological inflammatory markers and tissue damage markers: interleukin-6, C-reactive protein, creatine kinase, white blood cell count, erythrocyte sedimentation rate;Patient satisfaction;Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Score;Quadriceps strength;Lower limb swelling degree: Circumference at 10cm above the patellar, 10cm below the patellar and 20cm above the medial malleolus of the affected side were measured respectively;American Knee Association (AKS) Score;