Evaluating of therapeutic results of metacarpal fixation using pin and mini-plate procedures in patients with transverse or short oblique metacarpal fractures
The aim of the current study is to compare the result of mini plate and K-wire fixation in transverse or short oblique metacarpal fracture
Design
This study will be a clinical trial with parallel groups with randomization using a random number table with a sample size of approximately 120 people. Study groups include Miniplate and K-wire
Settings and conduct
In 2020 to 2022 in Kashani Hospital, Isfahan province. All patients who referred to this center due to transverse or oblique metacarpal fractures were included in this study and were randomly included in one of the two study groups. After the operation, the complications and results of the operation will be compared. Outcome assessors were blinded in this study.
Participants/Inclusion and exclusion criteria
The inclusion criteria for patients were age between 18-50 years, Isolated closed transverse or oblique metacarpal fractures, candidacy for surgical treatment, and informed consent to enter the study. Exclusion criteria were simultaneous fracture in the upper limb or multiple trauma, unwillingness to participate in the study, non-referral for follow-up treatment, malignancy, osteoarthritis, major systemic disease, and taking drugs that affect fracture healing, such as steroid and anticancer drugs.
Intervention groups
Mini plate and K-wire group
Main outcome variables
ROM; DASH; sf36; infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230102057026N1
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Mohammad Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6543 5059
Email address
dr.mohammadamiri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
2023-02-20, 1401/12/01
Actual recruitment end date
2023-02-20, 1401/12/01
Trial completion date
2023-05-22, 1402/03/01
Scientific title
Evaluating of therapeutic results of metacarpal fixation using pin and mini-plate procedures in patients with transverse or short oblique metacarpal fractures
Public title
Evaluating of therapeutic results of metacarpal fixation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-50 years
Isolated closed transverse or oblique metacarpal fractures
candidacy for surgical treatment
informed consent to enter the study
Exclusion criteria:
simultaneous fracture in the upper limb or multiple trauma
unwillingness to participate in the study
non-referral for follow-up treatment
malignancy
osteoarthritis
major systemic disease
taking drugs that affect fracture healing, such as steroid and anticancer drugs
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A table of random numbers will be used for randomization, which will be placed in the first group if there is an even number and in the second group if there is an odd number.
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 isfahan University of Medical Sciences
Street address
Hezar garib
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.MUI.MED.REC.1400.635
Health conditions studied
1
Description of health condition studied
transverse or obligue metacarpal fracture
ICD-10 code
S62.20
ICD-10 code description
Unspecified fracture of metacarpal bone
Primary outcomes
1
Description
quality of life
Timepoint
3 and 12 months after surgery
Method of measurement
sf36 questionnaire
2
Description
disability
Timepoint
3 and 12 months after surgery
Method of measurement
DASH questionnaire
3
Description
infection
Timepoint
3 and 12 months after surgery
Method of measurement
physical exammination
4
Description
range of motion
Timepoint
3 and 12 months after surgery
Method of measurement
physical exammination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will undergo metacarpal fracture surgery with the help of miniplate
Category
Treatment - Devices
2
Description
Control group: metacrpal fracture surgery using k wire
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Doctor Mehdi Teimouri
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 0048
Email
mehdi.teimouri@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Mehdi Teimouri
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mehdi.teimouri@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Amiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dr.mohammadamiri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Amiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dr.mohammadamiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Amiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dr.mohammadamiri@yahoo.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