Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty

Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty - A Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06032507

Enrollment

100

Registered

2023-09-13

Start date

2022-03-01

Completion date

2024-09-10

Last updated

2025-11-18

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

Conditions

Knee

Keywords

Total Knee Arthroplasty Cementation, Bone cement penetration, High Pressure Pulsatile Lavage, Pulsatile lavage, Total Knee Arthroplasty

Brief summary

Background Bone irrigation is essential in cemented total knee arthroplasty surgical technique in order to improve cement penetration and interdigitation into cancellous bone, that is going to determine the strength of the bone-cement interface. Purpose To report the effect of high-pressure pulsatile lavage versus manual rinsing on bone cement penetration in total knee arthroplasty. Methods This is a single-centre, prospective, randomized, controlled clinical trial. The study included 100 patients undergoing primary total knee arthroplasty. All patients meeting inclusion criteria were randomly assigned to the pulsed lavage or non-pulsed lavage group. The cumulative bone cement penetration was radiologically assessed in antero posterior and lateral radiograph views in 10 zones according to the Knee Society Scoring System. A statistical analysis was performed between both groups comparing bone cement penetration cumulative scores.

Interventions

PROCEDUREBone lavage previous to cementation

Bone lavage previous to cementation in total knee arthroplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

100 patients undergoing primary TKA

Eligibility

Sex/Gender

ALL

Age

60 Years to 89 Years

Healthy volunteers

Yes

Inclusion criteria

* Age \>60 years * Age \<89 years * Clinical symptoms of knee osteoarthritis * Failed conservative treatment

Exclusion criteria

* Metal allergies * Active or latent knee sepsis * Extensor mechanism dysfunction * Morbid obesity * Several peripheral vascular disease * Noncompliance due to major psychiatric or neurological disorders.

Design outcomes

Primary

Measure	Time frame	Description
Cumulative bone cement penetration	48 hours postoperative xrays	The cumulative bone cement penetration was radiologically assessed in AP and lateral radiograph views in 10 zones according to the Knee Society Scoring System (for each zone, \<4 = nonprogressive, 5-9 = risk of progression, \>10 = risk of failure) - minimum 0, maximum non established-.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026