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Effect of retain synovium or synovectomy on inflammation and clinical outcomes in total knee arthroplasty: a prospective, randomized controlled study

Effect of retain synovium or synovectomy on inflammation and clinical outcomes in total knee arthroplasty: a prospective, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008245
Enrollment
Unknown
Registered
2016-04-08
Start date
2011-05-04
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Knee osteoarthritis

Interventions

A:Synovectomy during the staged bilateral TKA
B:No synovectomy during the staged bilateral TKA

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 81 Years

Inclusion criteria

Inclusion criteria: 1. Primary unilateral total knee artropasty; 2. Patients with Knee osteoarthritis; 3. Aged from 20-80 years with no limitation of gender; 4. Patients who volunteered to participate in clinical trials and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients combined with acute trauma, tumor, severe osteoporosis, other autoimmune diseases and severe muscle contracture deformity around hip/knee; 2. Previous history of neuro-vascular injury, vasculitis and diabetic foot etc; 3. Related thrombosis history, such as pulmonary embolism, thrombosis and deep vein thrombosis in recent three months; 4. Coagulation disorders, bleeding tendency or intraoperative active bleeding; 5. Sever comorbidities in brain cardiovascular system, liver (ALT or AST > 2 high limitation of normal value), kidney (BUN > 1.5 high limitation of normal value or Cr > 1.5 high limitation of normal value), endocrine, nerve, hematopoietic system or consciousness disorders; 6. Pregnancy or breast-feeding; 7. Allergy to the test drug and human serum albumin, severe allergies, drug or alcohol depedence; 8. Participate in other clinical trials in recent three months; 9. The surgeons believe the patients not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
postoperative inflammation (ESR; CRP; IL-6);drainage fluid inflammation (ESR; CRP; IL-6);Knee range of motion;

Secondary

MeasureTime frame
AKS;KOOS;SF-12;drainage fluid amount;Limb swelling;peri-temperature;Tension vesicle;Ecchymosis;Hb;Hit;albumin;operation time;postoperative blood loss;

Countries

China

Contacts

Public ContactZhou Zong-ke

West China Hospital, Sichuan University

zongke@126.com+86 18980601028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026