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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06117839
Study type Observational
Source Assiut University
Contact Ahmed Sallam Abo El-azaiem, bachelor's
Phone 01005732964
Email ahmedsallam2020159@gmail.com
Status Not yet recruiting
Phase
Start date December 1, 2023
Completion date January 1, 2025

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