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Effect of Transverse Versus Longitudinal Incision in Anterior Knee Pain after Tibial Nailing

Protocol summary

Study aim
Examination of Knee Pain After Transverse and Longitudinal Incision in Patients After Tibial Nailing
Design
A clinical trial with a control group, with parallel groups, without blinded, randomized, on 180 patients between July 2024 and July 2025. For simple random sampling, random numbers will be generated using Excel software.
Settings and conduct
This research is conducted on patients referred to Shahada Tajrish Hospital. The patients are divided into 2 groups, one group with longitudinal incision and one group with transverse incision. After the surgery, we follow up the patients in 2 weeks, 6 weeks, 12 weeks and 6 months after the operation and using a questionnaire We have already prepared the criteria of VAS and Functional Outcome and clinical examination of the nerve damage of the infrapatellar branch after surgery in two methods of these patients.
Participants/Inclusion and exclusion criteria
Patients in the Age Range of 18 to 60 Years with a Closed Fracture of the Tibia Without a History of Old Fracture and Non-union of the Tibia, Who Had Surgery Around the Knee, Fractures in the Same Side of Lower Extremity, History of Any Spine Problems, Fractures Accompanied by Vascular-Nerve Damage, Medical and psychiatric Problems, Open Fracture and History of Smoking, Alcohol and Drugs
Intervention groups
After the surgery, we will follow up the patients of both groups and by using a pre-prepared questionnaire, we will examine the criteria of VAS and Functional Outcome and the clinical examination of the nerve damage of the infrapatellar branch after the surgery in the two methods of these patients.
Main outcome variables
Examination of knee pain after transvers and longitudinal incision in patients after tibia nailing

General information

Reason for update
Acronym
TKP
IRCT registration information
IRCT registration number: IRCT20231209060316N1
Registration date: 2024-07-04, 1403/04/14
Registration timing: prospective

Last update: 2024-07-04, 1403/04/14
Update count: 0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
Mohammad Pourmahmoudian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2629 0177
Email address
mpourmahmoudian992@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2025-08-06, 1404/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Transverse Versus Longitudinal Incision in Anterior Knee Pain after Tibial Nailing
Public title
Effect of Transverse Incision in Knee Pain after Leg Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Closed Tibial Fractures between the Age of 18 - 60 Years
Exclusion criteria:
Patients with Severe Medical Conditions Patients with Open Fracture Patients with Psychiatric Problems Patients with Old Fracture and Tibia Nonunion Patients Who Had Surgery Around the Knee Patients with Fractures in the Same Side of Lower Extremity Patients with a History of Any Spine Problems Patients with a History of Smoking, Alcohol and Drugs Patients with Fractures Accompanied by Vascular-Nerve Damage Patients Under 18 and Over 60 Years Old
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
The Method of Selecting Patients Will be Simple Random Sampling Using Excel Software and Random Numbers Will be Generated. Even Numbers Belong to One Group and Odd Numbers Belong to Another Group.
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 Shahid Beheshti University of Medical Sciences
Street address
Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sqr., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2024-05-26, 1403/03/06
Ethics committee reference number
https://ethics.research.ac.ir/IR.SBMU.SRC.REC.1403.009

Health conditions studied

1

Description of health condition studied
Tibia fracture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
We will examine VAS and Functional Outcome criteria and clinical examination of infrapatellar nerve damage after surgery in two methods of these patients.
Timepoint
After the surgery, we follow up the patients in 2 weeks, 6 weeks, 12 weeks and 6 months after the operation.
Method of measurement
Using a pre-prepared questionnaire of VAS and Functional Outcome criteria and clinical examination of the nerve damage of the infrapatellar branch with the monofilament test

Secondary outcomes

1

Description
The amount of pain and the amount of bleeding, the length of the incision and the time of surgery, the amount of bleeding, blood transfusion and the patient's wound problems
Timepoint
During the operation, the amount of pain, the amount of bleeding, the length of the incision, and the time of the operation were recorded, and during the patient's stay in the hospital, the amount of bleeding, blood injection, and the patient's wound problems were followed up in 2 weeks, 6 weeks, 12 weeks, and 6 months after the operation.
Method of measurement
It is collected by a pre-prepared questionnaire and we follow up

Intervention groups

1

Description
Intervention group: Patients in this group undergo transverse incision for tibia nailing
Category
Treatment - Surgery

2

Description
Control group: Patients in this group undergo longitudinal incision for tibia nailing
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mohammad Pourmahmoudian
Street address
Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sqr., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Fax
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Web page address
https://shmc.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Rahmati
Street address
Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sqr., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Web page address
https://shmc.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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Pourmahmoudian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sqr., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2629 0177
Email
mpourmahmoudian992@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Pourmahmoudian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sqr., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2629 0177
Fax
+98 21 2629 0177
Email
mpourmahmoudian992@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Pourmahmoudian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shohadaye Tajrish Hospital, Shahrdari St., Tajrish Sqr., Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2629 0177
Fax
+98 21 2629 0177
Email
mpourmahmoudian992@gmail.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
Still undecided - no release schedule yet
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
Undecided - It is not yet known if there will be 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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