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

Primary Osteoarthritis of Knee Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117839
• Other study ID #: ahmedsallam
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Ahmed Sallam Abo El-azaiem, bachelor's
• Phone: 01005732964
• Email: ahmedsallam2020159[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our study will be a prospective 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 will be treated with regular bone cement ,the second one is patient will be treated with antibiotic loaded bone cement, commonly used antibiotics includeGentamycin powder.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

• Patient with any operative procedure in the knee.

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Primary Osteoarthritis of Knee Nos

Intervention

Procedure:
• using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.
-There are 2 groups ,first group is patients will betreated with regular bone cement ,the second one is patient will be treated with antibiotic loaded bone cement, commonly used antibiotics include Gentamycin powder .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection eradication rate	patients will be evaluated clinically and undergo lab evaluation (CRP and CBC).Patients will be routinely monitored for clinical signs of infection, including cellulitis or draining sinuses. Radiographs will be obtained at 2,6 and 12 months.; Laboratory tests as CRPwill be used to assess the infection.; A negative CRP indicate clean field and eradication of infection.	12 months postoperative
Secondary	Cost/benefit ratio.	study the cost in egyptian pound	12 months postoperative