Review the results of biceps tendon transfr to finger flexors by tensor facial graft in patient with volkmann ischemia
Design
This study was a single-group clinical trial with no control group.
Settings and conduct
This single-group clinical trial study will be performed in Shohada hospital in Tabriz. Blindness will not be achieved and all patients will have surgery. Patients with severe ischemia of the selected type undergo a tendon bypass transfer then are finger flexor by fascia lata graft then compared muscle strength and range of motion and rapid movements before and after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Severe Walkman syndrome
Exclusion criteria: Infectious diseases
Intervention groups
Patients with severe ischemia of the selected type undergo a tendon bypass transfer then are finger flexor by fascia lata graft then compared muscle strength and range of motion and rapid movements before and after surgery.
Main outcome variables
Wrist movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N12
Registration date:2019-11-29, 1398/09/08
Registration timing:prospective
Last update:2019-11-29, 1398/09/08
Update count:0
Registration date
2019-11-29, 1398/09/08
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review the results of biceps tendon transfr to finger flexors by tensor facial graft in patient with volkmann ischemia
Public title
Review the results of biceps tendon transfr to finger flexors by tensor facial graft in patient with volkmann ischemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe Walkman Syndrome
Exclusion criteria:
Infectious Diseases
Age
No age limit
Gender
Both
Phase
2
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.TBZMED.REC.1398.858
Health conditions studied
1
Description of health condition studied
Finger anomaly and deformity
ICD-10 code
M20.0
ICD-10 code description
Deformity of finger(s)
Primary outcomes
1
Description
Wrist movement
Timepoint
Three months after the study and then up to one year each month
Method of measurement
sollerman hand function test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study was a single-group clinical trial with no control group.This single-group clinical trial study will be performed in Shohada hospital in Tabriz. Blindness will not be achieved and all patients will have surgery. Patients with severe ischemia of the selected type undergo a tendon bypass transfer then are finger flexor by fascia lata graft then compared muscle strength and range of motion and rapid movements before and after surgery. After surgery, hand function status is measured by Solerman questionnaire in the third month.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Farzad Farrokhi
Street address
Azadi Ave, Shohada Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
farzadfaroxi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Shohada Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Faezad Farrokhi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shohada Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
farzadfaroxi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Moharrami
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shohada Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
mmoharrami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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
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