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

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

Status: Completed

Conditions: Knee

Treatments: Procedure: Bone lavage previous to cementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06032507

IIBSP-HPL-2021-90

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 60 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Pulsed lavagegroup

Experimental group

Description:

Bone cementation with previous high-pressure pulsatile lavage

Treatment:

Procedure: Bone lavage previous to cementation

Non-pulsed lavage group

Experimental group

Description:

Bone cementation with previous manual rinsing lavage

Treatment:

Procedure: Bone lavage previous to cementation