Protocol summary

Study aim
Correction of ulnar deviation in patients with ulnar nerve injury by transferring the extensor digiti minimi tendon and then checking the amount of correction of the angle between the fifth and fourth finger by measuring the angle with a protractor
Design
A clinical trial without a control group and without blinding that is performed on 15 patients.
Settings and conduct
Patients with ulnar nerve injury rarely come to correct the deviation of the fifth finger, and this interventional surgery is performed very rarely. All surgeries are performed at Hazrat Fatemeh Zahra Hospital, affiliated to Iran University of Medical Sciences, by a professor of plastic surgery. The extensor digiti minime tendon will be separated from the fifth metacarpophalangeal joint and moved from the fifth compartment of the extensor to the fourth compartment and sutured on the radial side of the fifth metacarpophalangeal joint in the position of correcting the deviation of the fifth finger.
Participants/Inclusion and exclusion criteria
Patients with a previous history of ulnar nerve injury of the hand, who have deviation of the fifth finger due to the weakness of the hypothenar muscles, and have a desire to correct the deviation of the fifth finger.
Intervention groups
Transferring the extensor digiti minimi tendon from the fifth finger and moving that from it`s extensor compartment.
Main outcome variables
The degree of correction of deviation of the fifth finger

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230430058028N1
Registration date: 2024-01-31, 1402/11/11
Registration timing: retrospective

Last update: 2024-01-31, 1402/11/11
Update count: 0
Registration date
2024-01-31, 1402/11/11
Registrant information
Name
Ali Saadati Kanafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 1378
Email address
alisaadat60@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Extensor Digiti Minimi Tendon (EDM) transfer on Ulnar Deviation of the Little Finger in patients with ulnar nerve injury
Public title
The effect of Extensor Digiti Minimi Tendon (EDM) transfer on Ulnar Deviation of the Little Finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of ulnar nerve injury and deviation of the fifth finger as a result Willingness of the patient to participate in the study
Exclusion criteria:
Age less than 10 years old The patient's unwillingness to participate in the study
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Iran University of Medical Sciences. Shahid Hemmat Highway Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-09-05, 1400/06/14
Ethics committee reference number
IR.IUMS.FMD.REC.1400.365

Health conditions studied

1

Description of health condition studied
Wartenberg`s sign
ICD-10 code
G56.2
ICD-10 code description
Lesion of ulnar nerve

Primary outcomes

1

Description
The amount of fifth finger deviation correction
Timepoint
Measuring the deviation angle of the fifth finger before the intervention and 3 months after the intervention
Method of measurement
goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: performing surgery to transfer the extensor tendon of digital mini-me and move its extensor compartment from 5 to 4 and re-stitch the tendon to correct the fifth deviation, which is performed by a plastic surgeon professor. The patient will wear an extensor brace for three weeks and then be referred for 2 months of physical therapy. Three months after the surgery, the degree of angle change and correction of the deviation of the fifth finger will be measured with a goniometer.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Ali Saadati Kanafi
Street address
Hazerat Fatemeh Hospital; 21 Ave. Asad Abadi Street;
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8810 7658
Email
crtfatima@iums.ac.ir
Web page address
https://crtfatima.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Hemat Highway; next to Milad Tower; Iran University of Medical Science
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Fax
+98 21 8862 2675
Email
Rezafalak@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Saadati Kanafi
Position
Plastic and Reconstructive surgery Fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No 12.Faali Alley. Shadmehr Street.
City
Tehran
Province
Tehran
Postal code
1456839515
Phone
+98 21 6653 1378
Email
alisaadat60@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Saadati Kanafi
Position
Plastic and Reconstructive surgery Fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No 12. Faali Alley. Shadmehr Street.
City
Tehran
Province
Tehran
Postal code
1456839515
Phone
+98 21 6653 1378
Email
alisaadat60@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Saadati Kanafi
Position
Plastic and Reconstructive Surgery Felloship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No 12. Faali Alley. Shadmehr Street
City
Tehran
Province
Tehran
Postal code
1456839515
Phone
+98 21 6653 1378
Email
alisaadat60@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of the data is allowed under the condition that the names of the patients are kept confidential.
From where data/document is obtainable
Dr Ali Saadati Kanafi Mobile 00989128078138 email alisaadat60@gmail.com Hazrat Fatemeh Hospital. 21 Alley. Asad Abadi Ave. Tehran
What processes are involved for a request to access data/document
The request to receive data will be answered within a maximum period of one week after receiving the request.
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