Clinical trial NCT06032507: Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty
Official title: Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee
Keywords: Total Knee Arthroplasty Cementation
Bone cement penetration
High Pressure Pulsatile Lavage
Pulsatile lavage
Total Knee Arthroplasty
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 100 patients undergoing primary TKA
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative bone cement penetration
timeFrame: 48 hours postoperative xrays
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
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