Comparison of the outcomes of tendon transfer and tendon graft in delayed repair of flexor pollicis longus (FPL) tendon in Hazrat Fatemeh hospital in 2022
Comparison of the results of delayed repair of flexor pollicis longus (FPL) tendon with tendon transfer or with tendon graft in Hazrat Fatemeh hospital
Design
A randomized clinical trial with two parallel groups, 20 patients; randomization will be done by sealed pockets.
Settings and conduct
Patients who come to Hazrat Fatemeh Hospital with FPL tendon injury and it is possible that primary tendon repair is not possible in them, undergo surgery after obtaining consent. During surgery, if it is confirmed that primary repair is not possible, they are randomly placed in one of the two groups of tendon transfer or tendon graft and are operated with the specified method. After the operation, the usual care including splint for four weeks and physiotherapy will be done as necessary. At intervals of three and six months after the surgery, the range of motion of the IP and MP joints of the finger is determined and compared in two groups. Blinding of the surgeon is not possible, but the personnel of the occupational therapy unit who performs the measurements will be blinded to the surgical procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
all of the patients with FPL tendon injury in whom primary repair of tendon is not possible.
Exclusion criteria:
the tendon injury is mild and do not need repair; primary repair of tendon is possible; patients who need hunter or pulley reconstruction; patients who prefer a specific method of tendon repair; patients who have limmited motion of thumb joints due to joint injuty.
Intervention groups
One group will be repaired with tendon transfer and the other group with tendon graft.
Main outcome variables
Range of motion (ROM) of IP and MP joints of thumb in the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211007052691N1
Registration date:2022-10-21, 1401/07/29
Registration timing:registered_while_recruiting
Last update:2022-10-21, 1401/07/29
Update count:0
Registration date
2022-10-21, 1401/07/29
Registrant information
Name
Mehdi Tassalibakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
dr_tasallibakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcomes of tendon transfer and tendon graft in delayed repair of flexor pollicis longus (FPL) tendon in Hazrat Fatemeh hospital in 2022
Public title
Comparison of the results of delayed repair of flexor pollicis longus (FPL) tendon with tendon transfer or with tendon graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with FPL tendon injury
primary repair of tendone is not possible
Exclusion criteria:
patients prefer a specific method
the tendon injury is mild and do not need repair
patients who need hunter or pulley reconstruction due to injury to tendon tract
patients who have limmited joint motion due to joint injury
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
we will have a simple randomization by sealed pockets. in each pocket one of the two methds of repair is written and for each patient one of the pockets will be opened.
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 Iran University of Medical Sciences
Street address
Room No. 346, 2th floor, medicine faculty, Iran University of Medical Scienses, beside of Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.IUMS.FMD.REC.1400.650
Health conditions studied
1
Description of health condition studied
Flexor Pollicis longus tendon injury
ICD-10 code
T14.6
ICD-10 code description
Injury of muscles and tendons of unspecified body region
Primary outcomes
1
Description
Range Of Motion of IP joint of the injured thumb
Timepoint
3 and 6 months after the surgery
Method of measurement
by goniometer
2
Description
Range Of Motion of MP joint of the injured thumb
Timepoint
3 and 6 months after the surgery
Method of measurement
by goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: FPL tendon repair with tendon transfer
Category
Treatment - Surgery
2
Description
Intervention group: FPL tendon repair with tendon graft
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh hospital
Full name of responsible person
Mehdi Tassallibakhsh
Street address
21th Ave., Yousefabad St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
crtfatima@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keivan
Street address
5th floor, Iran University of Medical Scienses, beside of Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2703
Email
info@iums.ac.ir
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
Mehdi Tassallibakhsh
Position
fellow
Latest degree
Specialist
Other areas of specialty/work
plastic and reconstructive surgery
Street address
Unit 4, No. 1, SoltaniAzar Alley, Ostad Hassan Banna St. Heravi Sq.