Effect of combination of syringe lavage and brush compared with pulsed lavage on cement penetration of tibial component in primary TKA: a randomized, controlled, non-inferiority trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250118002

Enrollment

Registered

2025-01-18

Start date

2024-08-12

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

primary osteoarthritis of knee undergoing primary total knee arthroplasty cement penetration, pulsed lavage, syringe lavage, brush, total knee arthroplasty

Interventions

other procedure in total knee arthroplasty was same between 2 groups. before cementation, tourniquet was inflated on affected leg. The pressure of tourniquet was calculated from Recommend tourniquet p

Tibial tray completed.,other procedure in total knee arthroplasty was same between 2 groups. before cementation, tourniquet was inflated on affected leg. The pressure of tourniquet was calculated from

Tibial tray completed.

Experimental Procedure/Surgery,Active Comparator Procedure/Surgery

syringe lavage with brush,pulsed lavage

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Population diagnosed with osteoarthritis of knee undergoing primary total knee arthroplasty(TKA) 2.Age between 50 and 85 years

Exclusion criteria

Exclusion criteria: 1.Population diagnosed with secondary osteoarthritis of knee such as rheumatoid arthritis, crystal-induced arthritis, post traumatic osteoarthritis, infection induced osteoarthritis, Paget's disease, hemophilia etc. 2.revision of total knee arthroplasty 3.bilateral TKA 4.Severe bone defect at tibial side 5.use stem augmentation 6.implant other than Cruciate retaining - PFC SigmaTM (Depuy) 7.unwilling to participate in the study or want to leave before the study end

Design outcomes

Primary

Measure	Time frame
cement penetration of Tibia AP and lateral at post operative day 1 and post operative 1 week in same film to measure reliability millimeter in two decimal places in film Tibia AP, lateral	—

Secondary

Measure	Time frame
cement penetration of Femur lateral at post operative day 1 and post operative 1 week in same film to measure reliability millimeter in two decimal places in film Femur laterall,pathologic radiolucent line 3,6,12 months post operative radiolucent line in film knee AP, lateral ,WOMAC score 3,6,12 months post operative self report questionnaire,Tourniquet time intraoperative minutes,complication until 1 year Any complication associated with TKA	—

Measure

Time frame

cement penetration of Femur lateral at post operative day 1 and post operative 1 week in same film to measure reliability millimeter in two decimal places in film Femur laterall,pathologic radiolucent line 3,6,12 months post operative radiolucent line in film knee AP, lateral ,WOMAC score 3,6,12 months post operative self report questionnaire,Tourniquet time intraoperative minutes,complication until 1 year Any complication associated with TKA

—

Countries

Thailand

Contacts

Public ContactChayutapong Hsu

Vajira hospital

chayutapong.hsu@nmu.ac.th0840849960

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026