Infections Joint ProstheticNCT06451224
Egyptian Arthroplasty Surgeons' Antibiotics Usage Awareness
An observational study of Infections Joint Prosthetic, run by South Valley University at 1 site in Egypt.
Trial summary
Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are procedures successfully applied to manage various end-stage chronic hip and knee diseases, such as osteoarthritis, rheumatoid arthritis, and femoral head avascular necrosis, as well as acute conditions, such as the neck of femur fractures, with… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Infections Joint Prosthetic
- What is being tested?
- Questionnaire
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2024to 30 Sep 2024
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Active practicing Egyptian joint replacement surgeons
Who may be able to join
- All Egyptian registered members of the Egyptian Pelvis and Hip Society, practicing Egyptian joint replacement surgeons (performing surgeries as a leading surgeon) who are willing to participate
Who cannot join
- Members not listed in the E-mail directory of the society
- Surgeons refusing to participate
- Young surgeons who are not practicing independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attitudes of Prophylactic Antibiotic Utilization During Primary Total Hip and Knee Arthroplasty Among Egyptian Joint Replacement Surgeons
Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are procedures successfully applied to manage various end-stage chronic hip and knee diseases, such as osteoarthritis, rheumatoid arthritis, and femoral head avascular necrosis, as well as acute conditions, such as the neck of femur fractures, with excellent long-term functional outcomes. One of the devastating complications after such a procedure is periprosthetic joint infection (PJI). Various precautions are proposed to guard against such complications; one is the administration of perioperative antibiotics. However, injudicious or misuse of antibiotics could lead to the emergence of antimicrobial resistance, further complicating this matter. This is why various scientific and research organizations have proposed guidelines and a consensus for proper antibiotic use in perioperative THA and TKA surgery.
Antibiotic prophylaxis during primary THA and TKA can reduce the risk of PJI and surgical site infections. However, there is a lack of consensus on the optimal dosages and duration of prophylaxis, and guidelines vary among institutions. Alternatives such as extended oral antibiotic prophylaxis and different antibiotic regimens are being explored. International research is needed to establish best practices and determine the potential risks of antibiotic prophylaxis during primary THA and TKA. Unfortunately, the investigators are unaware of such guidelines proposed by any Egyptian health authority to guide and control the proper utilization of antibiotics during orthoapedic practice in general and joint replacement surgeries (THA and TKA) in particular.
Read the detailed description
This study will be an Online-based questionnaire investigating surgeons' perspectives on antibiotics utilization during primary total hip and knee arthroplasty surgeries and investigate their thoughts about the necessity for developing local guidelines.
- Conditions
- Infections Joint Prosthetic
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Online Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the type of antibiotics administration during primary total hip and knee arthroplasty
The type of antibiotics will be determined as follows: the name of the antibiotic (brand or generic), and if single or dual antibiotics are used. These will be presented as numbers and percentages.
Measured: 2 months
Secondary outcomes (3)
To determine the dose of antibiotics administered during primary total hip and knee arthroplasty
The dose of antibiotics will be determined as grams or milligrams. Furthermore, the number of doses will be reported
Measured: 2 months
To determine the timing of antibiotics administration during primary total hip and knee arthroplasty
Regarding the timing, preoperative antibiotic administration will be reported in minutes
Measured: 2 months
To determine the length of antibiotics administration during primary total hip and knee arthroplasty
the length of antibiotic administration postoperatively will be calculated in days.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start15 Jun 2024
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections Joint ProstheticStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Ahmed A. Khalifa, MD, FRCS, MSc, South Valley University
- Investigators
- Ahmed Abd El-Aal, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451224
- Sponsor's protocol ID
- 04-2024-300439
- Status last verified
- Oct 2024
- First submitted
- 23 May 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes of Prophylactic Antibiotic Utilization During Primary Total Hip and Knee Arthroplasty Among Egyptian Joint Replacement Surgeons
- ClinicalTrials.gov ID
- NCT06451224
- Acronym / sponsor ID
- 04-2024-300439
- Conditions
- Infections Joint Prosthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 11 Jun 2024 (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.
Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are procedures successfully applied to manage various end-stage chronic hip and knee diseases, such as osteoarthritis, rheumatoid arthritis, and femoral head avascular necrosis, as well as acute conditions, such as the neck of femur fractures, with excellent long-term functional outcomes. One of the devastating complications after such a procedure is periprosthetic joint infection (PJI). Various precautions are proposed to guard against such complications; one is the administration of perioperative antibiotics. However, injudicious or misuse of antibiotics could lead to the emergence of antimicrobial resistance, further complicating this matter. This is why various scientific and research organizations have proposed guidelines and a consensus for proper antibiotic use in perioperative THA and TKA surgery.
Antibiotic prophylaxis during primary THA and TKA can reduce the risk of PJI and surgical site infections. However, there is a lack of consensus on the optimal dosages and duration of prophylaxis, and guidelines vary among institutions. Alternatives such as extended oral antibiotic prophylaxis and different antibiotic regimens are being explored. International research is needed to establish best practices and determine the potential risks of antibiotic prophylaxis during primary THA and TKA. Unfortunately, the investigators are unaware of such guidelines proposed by any Egyptian health authority to guide and control the proper utilization of antibiotics during orthoapedic practice in general and joint replacement surgeries (THA and TKA) in particular.
Detailed description
This study will be an Online-based questionnaire investigating surgeons' perspectives on antibiotics utilization during primary total hip and knee arthroplasty surgeries and investigate their thoughts about the necessity for developing local guidelines.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active practicing Egyptian joint replacement surgeons
Key inclusion criteria (1 listed)
- All Egyptian registered members of the Egyptian Pelvis and Hip Society, practicing Egyptian joint replacement surgeons (performing surgeries as a leading surgeon) who are willing to participate
Key exclusion criteria (3 listed)
- Members not listed in the E-mail directory of the society
- Surgeons refusing to participate
- Young surgeons who are not practicing independently
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 |
|---|---|---|
| QuestionnaireOnline Questionnaire | Other | – |
Primary outcome
To determine the type of antibiotics administration during primary total hip and knee arthroplasty
Time frame: 2 months
The type of antibiotics will be determined as follows: the name of the antibiotic (brand or generic), and if single or dual antibiotics are used. These will be presented as numbers and percentages.
3 secondary outcomes
To determine the dose of antibiotics administered during primary total hip and knee arthroplasty
Time frame: 2 months
To determine the timing of antibiotics administration during primary total hip and knee arthroplasty
Time frame: 2 months
To determine the length of antibiotics administration during primary total hip and knee arthroplasty
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Abd El-Aal, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections Joint Prosthetic, run by South Valley University at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the type of antibiotics administration during primary total hip and knee arthroplasty (time frame: 2 months). 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 16 Oct 2024.