The effect of intra-articular injection of clindamycin in reducing postoperative infection rate of total knee arthroplasty: double-blind randomized clinical trial
Investigating the effect of intra-knee clindamycin injection in degenerative joint disease patients in reducing the rate of postoperative infection in a double-blind randomized clinical trial.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 1916 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study will be conducted as a clinical trial on all degenerative joint disease patients who will be placed in Imam Hossein (AS) Hospital and Atiyeh Total Knee Arthroplasty Hospital in the years 2023-2024.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering degenerative joint disease; The need for total knee arthroplasty surgery; Having complete satisfaction; Absence of disease. Exclusion criteria: Lack of consent to participate in the study; Suffering a disease other than degenerative joint disease; Hypersensitivity to any of the drugs used in the study; Dissatisfaction with performing total knee arthroplasty surgery.
Intervention groups
For the clindamycin group, the combination of clindamycin with a dose of 600 mg along with ketorolac, tranexamic acid and marcaine will be injected intra-articularly, and for the control group ketorolac, tranexamic acid and marcaine without clindamycin will be injected intra-articularly.
Main outcome variables
Infection; Pain; Heat; Redness; Swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240213061004N1
Registration date:2024-05-24, 1403/03/04
Registration timing:retrospective
Last update:2024-05-24, 1403/03/04
Update count:0
Registration date
2024-05-24, 1403/03/04
Registrant information
Name
Mohammadmahdi Sarzaeim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
dr.mohammadmahdi-sarzaeim@sbma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-01, 1402/10/11
Expected recruitment end date
2024-03-01, 1402/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intra-articular injection of clindamycin in reducing postoperative infection rate of total knee arthroplasty: double-blind randomized clinical trial
Public title
Intra-articular injection of clindamycin in reducing postoperative infection rate of total knee arthroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Degenerative Joint Disease
Indications for total knee arthroplasty
Informed consent
Exclusion criteria:
Lack of consent to participate in the study
Suffering a disease other than degenerative joint disease
Hypersensitivity to any of the drugs used in the study
Dissatisfaction with performing total knee arthroplasty
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
958
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups by a simple random method.
In this research, the coin toss will be used to create a random sequence in a two-group trial. So that one of the study groups is tail and the other group is considered as a head, and according to the sample size, the same amount of coin is tossed and the subjects are divided into two groups of random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The block randomization method with unequal block sizes was used to hide the allocation sequence. For this purpose, the allocation list was prepared in advance by the co-researcher, who was not the patient's assessor or allocator, using web-based software.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran
Street address
Shahid Arabi St, Yemen St, Shahid Chamran Highway, Tehran
City
Thehran
Province
Tehran
Postal code
4631- 19395
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.SBMU.MSP.REC.1402.501
Health conditions studied
1
Description of health condition studied
Total knee arthroplasty
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
Infection
Timepoint
2 weeks, 1 month and 3 months.
Method of measurement
Pain, heat, redness, swelling. If these symptoms are present, CRP and ESR are tested. If the results of the tests are abnormal, a smear and culture will be done for the patient from joint fluid aspiration, and if the results are positive, the case of joint infection will be known.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The combination of clindamycin with a dose of 600 mg with ketorolac, tranexamic acid and marcaine will intra-articular injection.
Category
Prevention
2
Description
Control group: Ketorolac, tranexamic acid and marcaine without clindamycin are injected intra-articularly.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Hospital Tehran
Full name of responsible person
Dr. Amirhossein Zablian
Street address
Imam Hossein (AS) Hospital, at the beginning of Shahid Madani Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 0217 3430
Email
zabolianamirhossein@gmail.com
Web page address
https://azmayeshonline.com/hospital
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zali
Street address
Shahid Arabi St, Yemen St, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Sarzaim
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Central Organization of Tehran University of Medical Sciences, Qods St. Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 2260 0037
Email
zabolianamirhossein@gmail.com
Web page address
https://education.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hossein Zablian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Central Organization of Tehran University of Medical Sciences, Qods St. Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 2260 0037
Email
zabolianamirhossein@gmail.com
Web page address
https://education.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hossein Zablian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Central Organization of Tehran University of Medical Sciences, Qods St. Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 2260 0037
Email
zabolianamirhossein@gmail.com
Web page address
https://education.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD