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Completed

NCT Number: NCT06032507

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

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.

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Key information

Conditions

Knee

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone lavage previous to cementation

Procedure

Bone lavage previous to cementation in total knee arthroplasty

Primary outcomes

  1. Cumulative bone cement penetration

    Time frame: 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-.

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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