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

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee

Intervention / Treatment
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* Procedure: Bone lavage previous to cementation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 100 patients undergoing primary TKA
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed lavagegroup<br>Bone cementation with previous high-pressure pulsatile lavage | Procedure: Bone lavage previous to cementation<br>* Bone lavage previous to cementation in total knee arthroplasty<br>|
| Experimental: Non-pulsed lavage group<br>Bone cementation with previous manual rinsing lavage | Procedure: Bone lavage previous to cementation<br>* Bone lavage previous to cementation in total knee arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative bone cement penetration | 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-. | 48 hours postoperative xrays | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty Cementation, Bone cement penetration, High Pressure Pulsatile Lavage, Pulsatile lavage, Total Knee Arthroplasty