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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06117839
Collaborator
(none)
42
13

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
42 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Comparative Study Between Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Infection eradication rate [6 weeks postoperative]

    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.

Secondary Outcome Measures

  1. Cost-effectiveness. [6 week postoperative]

    study the cost in egyptian pound

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Sallam Abo El-azaiem Mohamed, Resident physcian at orthopedic surgery and truamatology, Assiut University
ClinicalTrials.gov Identifier:
NCT06117839
Other Study ID Numbers:
  • ahmedsallam
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Oct 1, 2023
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023