Comparison results of acromioclavicular dislocations treatment by screw, with and without coracoclavicular suture in patients with acute acromioclavicular dislocations
- Aim of study: comparing two surgical methods in acute dislocations of acromiococlavicular joint by using absorbable suture and coracoclavicular screw
- Designing the study: randomized controlled trial,not blinded,two-centered
- Main inclusion criteria: No history of surgery and former trauma in the same shoulder joint and upper limb
-Main exclusion criteria: multi traumatic patients and type 3 and 6 dislocations
- Population being studied: Patients with acute Acromioclavicular joint dislocations
The volume of the sample: 40 patients
The intervention being studied: open reduction and fixation with screw and coracoclavicular suture with the one without suture
Duration of intervention: 4 years
Primary outcome measures:Constant score, Visual Analog Score (VAS), and restoring shoulder function
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061018030N1
Registration date:2014-11-09, 1393/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-09, 1393/08/18
Registrant information
Name
Meisam Baiman
Name of organization / entity
Medicine Faculty of Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3440 4372
Email address
elmia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
With the support of Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison results of acromioclavicular dislocations treatment by screw, with and without coracoclavicular suture in patients with acute acromioclavicular dislocations
Public title
The comparison between two surgical methods in acute dislocations of acromiococlavicular joints
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent for participating in the trial ; No history of surgery and former trauma in the same shoulder joint and upper limb ; No history of systemic disorders such as Diabetes and hyperthyroidism or hypothyroidism ; No history of former pathology in the same joint such as calcified tendinitis ; No simultaneous fractures in the time of damage
Exclusion criteria: Multi traumatic patients ; type 3 and 6 dislocations
Age
From 20 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Research council of Ethics Committe of Tabriz University of Medical Sciences
Street address
Research deputy, third floor, central building number 2, Tabriz University of Medical Sciences,Golgasht street
City
Tabriz
Postal code
Approval date
2009-01-20, 1387/11/01
Ethics committee reference number
93112
Health conditions studied
1
Description of health condition studied
Acute dislocations of acromioclavicular joint
ICD-10 code
s43.1
ICD-10 code description
ِDislocations of Acromioclavicular joint
Primary outcomes
1
Description
constant
Timepoint
third,sixth and twelfth weeks after intervention
Method of measurement
standard Constant questionnaire
2
Description
restoring shoulder function
Timepoint
Three and six months after intervention
Method of measurement
Restoring the shoulder range of motion
3
Description
Visual Analog Scale (VAS)
Timepoint
Thirs, sixth, and twelfth weeks after intervention
Method of measurement
Based on patients' statements, subjectively
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group in addition to open reduction and fixation with screw, coracoclavicular suture with 3 bands of absorbable sutures(Vicryle)was used.
Category
Treatment - Surgery
2
Description
Control group:20 patients in control group were only fixated by coracoclavicular screw withou any sutures.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Asghar Elmi
Street address
Orthopedics educational group, Shohada Hospital, Golshahr street, El Goli broadway
City
Tabriz
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Asghar Elmi
Street address
Imam Reza Hospital, Daneshgah street
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Saeid Aslanabadi
Street address
Orthopedics educational group, Shohada Hospital, Golshahr street, El Goli broadway
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghar Elmi
Position
Orthopedician
Other areas of specialty/work
Street address
Orthopedics educational group, Shohada Hospital, Golshahr street, El Goli broadway
City
Tabriz
Postal code
Phone
+98 41338593147
Fax
Email
elmimail@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghar Elmi
Position
Orthopedician
Other areas of specialty/work
Street address
Orthopedics educational group, Shohada Hospital, Golshahr street, El Goli broadway
City
Tabriz
Postal code
Phone
+98 41338593147
Fax
Email
elmimail@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghar Elmi
Position
Orthopedician
Other areas of specialty/work
Street address
Orthopedics educational group, Shohada Hospital, Golshahr street, El Goli broadway
City
Tabriz
Postal code
Phone
+98 41338593147
Fax
Email
elmimail@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)