Comparing clinical outcomes of clavicle fracture surgical treatment methods of fixation with two plates 2.7 millimeters and fixation with plate 3.5 millimeters
In this study, we will investigate the use of the double plate method for fixation of clavicle fractures and compare its complications and efficiency with the method of fixation with a single plate.
Design
A clinical trial with a control group, with parallel randomized groups, was used to assign numbers to patients based on random number table numbers for randomization.
Settings and conduct
The surgeon and the patient are aware of the methods of surgical treatment, but the person who performs the patients' functional measurements after surgery is blind to the type of surgical procedure of the patients.
Participants/Inclusion and exclusion criteria
Patients aged 18-60 years with a middle third clavicle fracture shortened or displaced by 2 centimeters or more are included in the study. Patients with open fractures, fractures with neurovascular damage, and internal and external one-third fractures, and patients with multiple injuries will be excluded.
Intervention groups
In our study, we will surgically fix the clavicle fractures of group A using two 2.7 millimeters(mm) plates and group B with a 3.5 mm plate.
Main outcome variables
Bleeding amount in surgery, surgery time, incision length, orthopedic classification of fractures, and the disabilities of the arm, shoulder and hand (DASH) questionnaire score are the main outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053235N1
Registration date:2021-12-19, 1400/09/28
Registration timing:prospective
Last update:2021-12-19, 1400/09/28
Update count:0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Meisam Jafari Kafiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
dr.jafari8567@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing clinical outcomes of clavicle fracture surgical treatment methods of fixation with two plates 2.7 millimeters and fixation with plate 3.5 millimeters
Public title
Clavicle fracture surgical methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mid-shaft clavicle fractures
The fractures which are shortened or displaced by 2 centimeters or more
Exclusion criteria:
Distal third and medial clavicle fracture
Patients with neurovascular problems due to clavicle fracture
Patients with multiple traumas
Patients with open fractures
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by the simple randomization method based on the numbers assigned to them based on the table of random numbers.
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