Protocol summary

Study aim
Determining the best area for surgical incision of complete knee joint replacement in patients with old scars in Hazrat Rasool Akram Hospital.
Design
Clinical trial of control group with randomized double-blind parallel groups with 44 patients
Settings and conduct
In the control group, patients will be subjected to a new incision at a safe distance of 7 to 8 cm from the old scar by the standard method, and in the intervention group, patients will undergo an incision at a closer distance on the patient's knee. The results of the study will be evaluated and compared in terms of the possible occurrence of any skin complication in patients and the general results of surgery in the time intervals of 1 week, 2 weeks and 1 month after surgery.
Participants/Inclusion and exclusion criteria
The patient is a candidate for complete knee replacement surgery. Age over 15 years in a patient The patient has an old scar caused by a previous surgical incision or lesion in the skin of the knee
Intervention groups
The incision site in both groups. In the intervention group, the incision site is cut midline regardless of the scar site, but in the control group, the incision site is incised at a distance of 8 cm from the scar site.
Main outcome variables
Age / sex / old scar / length of old scar / distance from surgical incision to old scar / type of previous surgery / skin necrosis after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180528039883N2
Registration date: 2021-08-08, 1400/05/17
Registration timing: registered_while_recruiting

Last update: 2021-08-08, 1400/05/17
Update count: 0
Registration date
2021-08-08, 1400/05/17
Registrant information
Name
Ali Yeganeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
yeganeh471@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the optimal area of surgical incision for total knee arthroplasty in patients with old scars
Public title
optimal area of surgical incision in total knee arthroplasty patients with old scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for total knee arthroplasty Have an old surgical scar on the knee within the surgical incision area Age over 15 years in pateint
Exclusion criteria:
Patients' dissatisfaction with participating in this research project
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the participants in the study using inclusion and non-inclusion criteria, to prevent the occurrence of bias in the selection of participants to intervention and control groups, we will use the randomization method to minimize the opinion of researchers in selecting participant to study groups. The block randomization method was used in this study. The size of the blocks is considered to be four and will be selected randomly so that it is not predictable to the participants based on the blocks. First, we will receive using Random Allocation software and by determining the sample size, the number of groups, the type of randomization and is random the order of the blocks in the software output and will be shown in the software output of groups with letters A and B. Then, after selecting each patient based on the inclusion and non-inclusion criteria, the project manager will be informed and he will tell the type of intervention of that patient based on the order of inclusion of patients and compliance with the number mentioned in the randomization output.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining informed consent and explaining that the selection in each group is done randomly by the program and how each group is done, the participants are divided into two groups without knowing which group they are in Obviously, if any of the participants object, it will be removed from the study list and routine treatment will be performed according to the protocol And the analyzer does not know which group each patient is in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of iran university of medical sciences
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
ir.iums.rec.1399.1450

Health conditions studied

1

Description of health condition studied
Determining the best area for a total knee arthroplasty surgical incision in patients with an old scar
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Skin incision healing
Timepoint
Before intervention / One week after intervention / 2 weeks after intervention / One month after intervention
Method of measurement
observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who try to total knee arthroplasty regardless of the distance from the scar site with the midline approach. That is, if the previous scar site is not spaced and overlaps with our midline incision, we will continue the midline approach. Campbell's book page 456 The distance between the old and the new incision should be at least 8 cm, but according to the mechanism of fasciomusculocotaneus flap and the method in which it is done, it seems that this amount of distance from the original incision is not necessary Did
Category
Treatment - Surgery

2

Description
Control group: Patients whose incision distance from the scar is at least 8 cm and is performed according to the book protocol
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital Tehran
Full name of responsible person
Ali Yeganeh
Street address
sattarkhan; Niyayesh St, 14456 13131
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2368
Email
yeganeh.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian, Vice Chancellor for research of Iran University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower ,Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://iums.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehan
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Fax
Email
yeganeh.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehan
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Fax
Email
yeganeh.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul e-Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehan
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Fax
Email
yeganeh.a@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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