Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty

Comparative Study Between Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty

Our study will be a retrospective study To compare between the rate of infection after using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.this will be at assiut university trauma hospital .There are 2 groups ,first group is patients treated with regular bone cement ,the second one is patient treated with antibiotic loaded bone cement, commonly used antibiotics include Vancomycin ,Gentamycin and Tobramycin powder used alone or in combination according to the organism present.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Osteoarthritis of Knee Nos
• Intervention / Treatment: Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.

Detailed Description

Total Joint arthroplasty (TJA) is among the major and most successful orthopedic surgeries . It is indicated when there is impaired joint function that requires prosthesis replacement .Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are the most replaced joints . TKA is becoming more common over the world, with 5 million degenerative knee joint replacement procedures projected by 2030 .

Although perioperative antimicrobial procedures have improved significantly, periprosthetic joint infection (PJI) following TKA remains a serious complication for patients and a significant burden on the healthcare system . PJI is a leading cause of TKA revision surgery, accounting for more than 15% of all revisions.that can cause a long hospital stay, increase the risk of readmission, and lead to poor patient outcomes, such as decreased function and a lower quality of life. In the worst case, PJI can lead to amputation or even death .

Antibiotic-loaded bone cement (ALBC) has been recommended to reduce the risk of PJI. The aim of such a strategy is to promptly release antibiotics at the action site with very little systemic exposure, which may not be achieved by systemic antibiotics due to insufficient blood supply (1) but in the literature, it is uncertain whether ALBC or plain bone cement (PBC) should be used in PTKA. ALBC has been shown to decrease significant complications, although it has the disadvantage of diminishing cement strength. A meta-analysis published in 2015 discovered no statistically significant difference in the incidence of PJI in patients receiving two cement materials during PTKA , another meta-analysis was done in 2022 demonstrated that the preventive application of ALBC during PTKA could reduce the rates of deep PJI, However, the existing related articles are mostly single-center and retrospective studies, and further high-quality ones are needed for confirmation ,so we will conduct our study to compare between ALBC and PBC in TKA infection.

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Ahmed Sallam Abo El-azaiem, bachelor's; Phone Number: 01005732964; Email: ahmedsallam2020159@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patient underwent TKA in primary osteoarthritis. Patient with rheumatoid knee osteoarthritis.

Patient with post-traumatic knee osteoarthritis, Patient with knee tumor. Patient has allergy to antibiotics used in the study are excluded.

Description

Inclusion Criteria:

• Patient with primary knee osteoarthritis.
• Patient underwent total knee arthroplasty.

Exclusion Criteria:

• Patient with rheumatoid knee osteoarthritis.
• Patient with post-traumatic knee osteoarthritis.
• Patient with knee tumor.
• Patient has allergy to antibiotics used in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; first group is patients treated with regular bone cement . Patients were routinely monitored for clinical signs of infection, including cellulitis or draining sinuses. Radiographs were obtained at 2,6 and 12 months.; Laboratory tests as CRP used to assess the infection.; A negative CRP indicate clean field and eradication of infection.	Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.; -There are 2 groups ,first group is patients treated with regular bone cement ,the second one is patient treated with antibiotic loaded bone cement, commonly used antibiotics include Vancomycin ,Gentamycin and Tobramycin powder used alone or in combination according to the organism present.
2; the second one is patient treated with antibiotic loaded bone cement, commonly used antibiotics include Vancomycin ,Gentamycin and Tobramycin powder used alone or in combination according to the organism present. Patients were routinely monitored for clinical signs of infection, including cellulitis or draining sinuses. Radiographs were obtained at 2,6 and 12 months.; Laboratory tests as CRP used to assess the infection.; A negative CRP indicate clean field and eradication of infection.	Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.; -There are 2 groups ,first group is patients treated with regular bone cement ,the second one is patient treated with antibiotic loaded bone cement, commonly used antibiotics include Vancomycin ,Gentamycin and Tobramycin powder used alone or in combination according to the organism present.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection eradication rate	patients was evaluated clinically and underwent lab evaluation (CRP).Patients were routinely monitored for clinical signs of infection, including cellulitis or draining sinuses. Radiographs were obtained at 2,6 and 12 months.; Laboratory tests as CRP used to assess the infection.; A negative CRP indicate clean field and eradication of infection.	6 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness.	study the cost in egyptian pound	6 week postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: ahmedsallam