Clinical trial NCT06117839: Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty
Official title: Comparative Study Between Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Osteoarthritis of Knee Nos
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient undergo 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 or Patient with any operative procedure in the knee are excluded.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Infection eradication rate
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Cost/benefit ratio.
timeFrame: 12 months postoperative
Other outcomes:
Locations:
Study officials:
References: