NCT06451224

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

May 23, 2024

Last Update Submit

October 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (3)

  • To determine the dose of antibiotics administered during primary total hip and knee arthroplasty

    2 months

  • To determine the timing of antibiotics administration during primary total hip and knee arthroplasty

    2 months

  • To determine the length of antibiotics administration during primary total hip and knee arthroplasty

    2 months

Interventions

Online Questionnaire

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Active practicing Egyptian joint replacement surgeons

You may qualify if:

  • 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

You may not qualify if:

  • Members not listed in the E-mail directory of the society
  • Surgeons refusing to participate
  • Young surgeons who are not practicing independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ahmed Abd El-Aal, MD

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 11, 2024

Study Start

June 15, 2024

Primary Completion

August 30, 2024

Study Completion

September 30, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations