Comparing the outcomes of side to side transfer of median nerve to the ulnar nerve with trnasfer of terminal branch of anterior intraosseous to the deep branch of the ulnar nerve and transfer of sensory nerve of third finger to the superficial branch of the ulnar nerve in patients with proximal ulnar nerve injury
Design
In this double-blinded randomized clinical trial, 40 patients will be randomly assigned to two equal and parallel groups using a random number table.
Settings and conduct
The current will be conducted in 15 khordad hospital. After randomization, the patients will undergo the surgery based on their group. The current study is a double-blind study as follows: the patients and examiner at the last visit will not be informed about the surgical procedure.
Participants/Inclusion and exclusion criteria
patients with high ulnar nerve injury included in the study
patients with chronic injury were excluded
Intervention groups
group I (side-to-side group): in this group, side-to-side transfer of median nerve to the ulnar nerve will be performed.
group II (AIN-sensory group): in this group, the terminal branch of anterior intraosseous nerve will be tranferred to the deep branch of the ulnar nerve associated with transfer of the sensory nerve of the third finger to the superficial branch of the ulnar nerve.
Main outcome variables
motor recovery of intrinsic muscle function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170502033783N2
Registration date:2021-05-30, 1400/03/09
Registration timing:retrospective
Last update:2021-05-30, 1400/03/09
Update count:0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
Masoud Yavari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21889021559
Email address
m_yavari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
2019-03-20, 1397/12/29
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2020-07-20, 1399/04/30
Scientific title
Two Techniques Of Median To Ulnar Nerve Transfer For Treatment Of High Ulnar Nerve Injuries :A Comparative Study
Public title
Two Techniques Of Median To Ulnar Nerve Transfer For Treatment Of High Ulnar Nerve Injuries :A Comparative Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
acute proximal ulnar nerve injury
Exclusion criteria:
associated nerve injury,
concomitant ipsilateral fracture,
nerve injury requiring graft,
previous CVA leading to paralysis of ipsilateral upper limb
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, random number table will be used. At first, a point on the table will be selected randomly. Then, the researcher's finger will move in row or column direction. Thus the first 15 two-digit numbers which will be equal to 30 or less be considered as the numbers of the side-to-side transfer group. Thus the numbers of the patients of the other group will be specified.
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
Ethical committee of Shahid Beheshti University of medical sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.261
Health conditions studied
1
Description of health condition studied
ulner nerve palsy at the level of elbow
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
DASH score will be used to measure the outcomes of surgery.
Timepoint
one year after the operation
Method of measurement
questionnaire
2
Description
two point discrimination test
Timepoint
one year after the operation
Method of measurement
The test will be performed using a unique device with two needles. The distance between the needle can be adjusted.
3
Description
Semmes Weinstein test
Timepoint
one year after the operation
Method of measurement
the test will be performed using a monofilament.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group, transfer of the anterior intraosseous nerve to the deep branch of the ulner nerve and transfer of the sensory nerve of the midle finger to the superficial branch of the ulnar nerve will be performed.
Category
Treatment - Surgery
2
Description
Intervention group: In this group, side to side transfer of the median nerve to the ulnar nerve (H graft) will be performed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
15th Khordad hospital
Full name of responsible person
Amir Bisadi
Street address
Karim Khan st, Azodi st
City
Tehran
Province
Tehran
Postal code
15987 64514
Phone
+98 21 8890 2155
Email
bisadi_a_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Reza Vafai
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2206
Email
reza.vafai@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
Amir Bisadi
Position
fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Karim Khan st, Azodi st
City
Tehran
Province
Tehran
Postal code
1598764514
Phone
+98 21 8890 2155
Email
bisadi_a_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Bisadi
Position
fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Karim Khan st, Azodi st
City
Tehran
Province
Tehran
Postal code
15987 64514
Phone
+98 21 8890 2155
Email
bisadi_a_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Bisadi
Position
fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Karim Khan st, Azodi st
City
Tehran
Province
Tehran
Postal code
15987 64514
Phone
+98 21 8890 2155
Email
bisadi_a_md@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The proposal and results will be available uopn email request.
When the data will become available and for how long
6 months after publication, the documents will be available upon request.
To whom data/document is available
hand surgeons- plastic surgeons- rehabilitation experts
Under which criteria data/document could be used
not applicable
From where data/document is obtainable
The doucments will be available upon resuest to bisadi_a_md@yahoo.com .
What processes are involved for a request to access data/document
The doucments will be available upon resuest to bisadi_a_md@yahoo.com .