Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty - A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cumulative bone cement penetration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 60 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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-.
Secondary Outcomes
No secondary outcomes reported