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

NCT06117839 | Unknown

• 1 other identifier: ahmedsallam
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Osteoarthritis of Knee Nos

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost/benefit ratio.

  12 months postoperative

Study Arms (2)

1

first group is patients will be treated with regular bone cement . Patients will be 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 and CBC will beused to assess the infection. * A negative CRP indicate clean field .

Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.

2

the second one is patient will be treated with antibiotic loaded bone cement, commonly used antibiotic includeGentamycin powder. Patients will beroutinely monitored for clinical signs of infection, including cellulitis or draining sinuses. Radiographs were obtained at 2,6 and 12 months. * Laboratory tests as CRP and CBC used to assess the infection. * A negative CRP indicate clean field.

Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.

Interventions

using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis. PROCEDURE

-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 .

1; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Ahmed Sallam Abo El-azaiem, bachelor's

CONTACT

01005732964; ahmedsallam2020159@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physcian at orthopedic surgery and truamatology

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11