Effects of diosmin on lower extremity swelling and enhanced recovery after joint replacement: a multicenter, prospective randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049077

Enrollment

Unknown

Registered

2021-07-20

Start date

2021-08-01

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Lower Extremity Swelling after Total Knee Arthroplasty

Interventions

Control group:Routine perioperative management

Study group:Diosmin

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who need primary unilateral TKA surgery due to severe knee osteoarthritis; 2. Aged 18 to 80 years; 3. The preoperative American Society of Anesthesiologists (ASA) classification (anesthesia risk assessment) is grade I-III; 4. Use a tourniquet, within 90 minutes of the operation time, use 20-25mg tranexamic acid to stop bleeding.

Exclusion criteria

Exclusion criteria: 1. Patients with heart, lung and other important organ failure; 2. Abnormal liver and kidney function (ALT, AST> 1.5 times the normal value, blood BUN> -8.3 mmol/L, blood Scr> 115 umol/L); 3. Diabetic patients with poor control of blood sugar levels, who are judged by the researchers to be at risk of infection; 4. Combined with disturbance of consciousness or mental illness; 5. Neuromuscular dysfunction affects lower extremity function; 6. Patients with severe coagulation disorders; 7. Combined with severe medical and surgical diseases or weak constitution, unable to tolerate surgery; 8. Severely unstable and incurable with ligament-preserving TKA; 9. There are active infection foci in the body (systemic or local infection lesions); 10. Women in family planning, lactation and pregnancy during the entire clinical research period; 11. Those who have participated in other clinical trials within 3 months; 12. The investigator believes that it is not suitable to participate in this clinical trial due to other reasons; 13. Knee flexion deformity >=30° or varus deformity >=30°; 14. Those who are allergic to the drugs used in this study; 15. Opioid addicts; 16. Language barriers and inability to complete the pain digital grading scale (Visual analogue scale, VAS); 17. Patients with venous system disease or venous insufficiency; 18. Patients with BMI > 40 kg/m2.

Design outcomes

Primary

Measure	Time frame
Swelling of lower limbs after surgery;	—

Secondary

Measure	Time frame
Postoperative VAS score;Knee HSS Score;Postoperative inflammation indicators;Complication rate;Joint range of motion;	—

Countries

China

Contacts

Public ContactKang Pengde

West China Hospital of Sichuan University

kangpd@163.com+86 18980601953

Outcome results

None listed

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