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Traditional Chinese medicine manipulation promoting the recovery process of tourniquet-related injuries after total knee arthroplasty: a prospective randomized controlled study

Traditional Chinese medicine manipulation promoting the recovery process of tourniquet-related injuries after total knee arthroplasty: a prospective randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051327
Enrollment
Unknown
Registered
2021-09-20
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

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

MeasureTime frame
Postoperative resting pain in the thigh and surgical site;

Secondary

MeasureTime 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

Public ContactZhang Yu

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

zhangyujoint@vip.163.com+86 15666778576

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026