Primary Osteoarthritis of Knee NosNCT06117839
Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty
An observational study of Primary Osteoarthritis of Knee Nos, run by Assiut University.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Osteoarthritis of Knee Nos
- What is being tested?
- using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Patient with primary knee osteoarthritis.
- Patient underwent total knee arthroplasty.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty
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.
Read the 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.
- Conditions
- Primary Osteoarthritis of Knee Nos
- Being tested
- using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.Procedure or surgery
-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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months postoperative
Secondary outcomes (1)
Cost/benefit ratio.
study the cost in egyptian pound
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Osteoarthritis of Knee NosStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sallam Abo El-azaiem Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117839
- Sponsor's protocol ID
- ahmedsallam
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06117839
- Acronym / sponsor ID
- ahmedsallam
- Conditions
- Primary Osteoarthritis of Knee Nos
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.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 . |
| 2 | – | Procedure: using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient with primary knee osteoarthritis.
- Patient underwent total knee arthroplasty.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 . | Procedure or surgery | 1, 2 |
Primary outcome
Infection eradication rate
Time frame: 12 months postoperative
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.
1 secondary outcome
Cost/benefit ratio.
Time frame: 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Osteoarthritis of Knee Nos, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sallam Abo El-azaiem, bachelor's (01005732964, ahmedsallam2020159@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection eradication rate (time frame: 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.