Comparison of clinical results and side effects of bilateral knee replacement simultaneously and 48 hours apart
Design
The study is a clinical trial using convenient non-probabilistic sampling method on 100 patients who are candidates for both knee joints.Patients will be divided into two groups of 50 people. For one group, both knee joints will be replaced at the same time, and for the other group, bilateral knee joints will be replaced 48 hours apart
Settings and conduct
This clinical trial study will be performed on people who were candidates for replacement of both knee joints and referred to Shahid Bahonar Hospital in Kerman in 1398.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients are candidates for joint replacement of both knees
Exclusion criteria:Previous major knee surgery؛ History of joint infection ؛ Chronic diseases such as diabetes ؛Immunodeficiency ؛Infection of other parts of the body or recent active infection
Intervention groups
first group: Patients who will have bilateral knee joints replacement simultaneously
second group:Patients who will have bilateral knee joints replacement 48 hours apart
Main outcome variables
Infection (Purulent discharge from the surgical site and redness and warmth and tenderness of the surgical site) ؛ Deep vein thrombosis ؛ Duration of hospitalization ؛ Pain ؛ Swelling ؛ joint Instability ؛ joint Locking ؛ Stair climbing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042514N6
Registration date:2020-06-17, 1399/03/28
Registration timing:retrospective
Last update:2020-06-17, 1399/03/28
Update count:0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Halimeh Kameshki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 8065
Email address
halimeh.kameshki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2020-01-30, 1398/11/10
Actual recruitment start date
2019-08-11, 1398/05/20
Actual recruitment end date
2020-02-04, 1398/11/15
Trial completion date
2020-05-09, 1399/02/20
Scientific title
Comparison of Clinical outcomes and complications of bilateral knee joint replacement simultaneously and after 48 hours
Public title
Comparison of Clinical outcomes and complications of bilateral knee joint replacement simultaneously and after 48 hours
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are candidates for joint replacement of both knees
all patient were from ASAI,II class
Exclusion criteria:
Previous major knee surgery
History of joint infection
Chronic diseases such as diabetes
Immunodeficiency
Infection of other parts of the body or recent active infection
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ibn Sina avenue; Jahad Blvd
City
kerman
Province
Kerman
Postal code
76198131592
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.KMU.REC.1398.221
Health conditions studied
1
Description of health condition studied
knee joint
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Infection (Purulent discharge from the surgical site and redness and warmth and tenderness of the surgical site)
Timepoint
2 week -1 months - 3 months After surgery
Method of measurement
Physical examination
2
Description
Deep vein thrombosis
Timepoint
2 week -1 months - 3 months After surgery
Method of measurement
Physical examination - sonography
3
Description
Duration of hospitalization
Timepoint
After surgery
Method of measurement
Physical examination
4
Description
Stair climbing
Timepoint
2 week -1 months - 3 months After surgery
Method of measurement
Lysholm questionnaire
5
Description
Joint Locking
Timepoint
2 week -1 months - 3 months After surgery
Method of measurement
Lysholm questionnaire
6
Description
Joint Instability
Timepoint
2 week -1 months - 3 months After surgery
Method of measurement
Lysholm questionnaire
7
Description
Swelling
Timepoint
2 week -1 months - 3 months After surgery
Method of measurement
Lysholm questionnaire
8
Description
Pain
Timepoint
2 week -1 months - 3 months After surgery
Method of measurement
Lysholm questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:first group includes patients who will have bilateral knee joints replacement Simultaneously : All patients will undergo the same anesthesia. Surgical method will be the same in all patients (classic knee replacement surgery) . antibiotics (48 hours of injectable cephalexin and then thirty cephalexin 500 mg every 6 hours) and painkillers (injection of one gram of apotel every eight hours). For 48 hours and then taking codeine acetaminophen every eight hours until five days after discharge) and anticoagulants (taking subcutaneous clexan for 14 days after discharge and all the time hospitalized once a day) will be the same after surgery too
Category
Treatment - Surgery
2
Description
Intervention group:The second group includes patients who will have bilateral knee joints replacements 48 hours apart : All patients will undergo the same anesthesia. Surgical method will be the same in all patients (classic knee replacement surgery) . antibiotics (48 hours of injectable cephalexin and then thirty cephalexin 500 mg every 6 hours) and painkillers (injection of one gram of apotel every eight hours). For 48 hours and then taking codeine acetaminophen every eight hours until five days after discharge) and anticoagulants (taking subcutaneous clexan for 14 days after discharge and all the time hospitalized once a day) will be the same after surgery too
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahounar Hospital
Full name of responsible person
Dr Afshin Heshmati
Street address
Qarani Avenue
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Afshin Heshmati
Street address
Haft Baghe Alavi
City
Kerman
Province
Kerman
Postal code
1355576169
Phone
+98 34 3325 7660
Email
amirreza.mirzaei@live.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Mirzaei Sosafidi
Position
Residency of Orthopedic
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Qarani Avenue
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Mirzaei Sosafidi
Position
Residency of Orthopedic
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Qarani Avenue
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Mirzaei Sosafidi
Position
Residency of Orthopedic
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Qarani Avenue
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
amirreza.mirzaei@live.com
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