The comparison of post-operation outcomes of acromioclavicular joint dislocation treatment using hook plate fixation and, arthroscopic and minimal invasive Endobuttom system
Determine and comparison of data for hook plate, open, and arthroscopic endobottom systems in ACJ dislocation
Design
A parallel-group, unblinded, randomized clinical trial on 180 patients. Randomization using the block randomization method in SPSS software
Settings and conduct
After obtaining the necessary permits, patients who have suffered an acute dislocation of ACJ and referred to Imam Hussein Hospital are included in the study if they meet the inclusion criteria and also give informed consent.
Participants/Inclusion and exclusion criteria
Including:
Acute acromioclavicular joint (ACJ) dislocation (up to 2 weeks after trauma)
High-grade dislocation (Rockwood III - V)
The capability of follow-up until one year after surgery
Not including:
Chronic ACJ dislocation (more than three weeks after trauma)
Recurrent dislocation
ACJ injury type III in patients older than 65 years
Data collection is not possible for at least one year after surgery
Intervention groups
- The treated group with hook plate endobottom method
- The treated group with the open endobottom method
- The treated group with hook plate endobottom method
Main outcome variables
Finding a method with fewer complications with faster and more complete rehabilitation in patients with acute ACJ dislocation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221110056460N1
Registration date:2022-12-10, 1401/09/19
Registration timing:prospective
Last update:2022-12-10, 1401/09/19
Update count:0
Registration date
2022-12-10, 1401/09/19
Registrant information
Name
hassan Barati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 9991
Email address
dr.hasan.barati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of post-operation outcomes of acromioclavicular joint dislocation treatment using hook plate fixation and, arthroscopic and minimal invasive Endobuttom system
Public title
comparison of Hook plate and Endobuttom Results
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute acromioclavicular joint (ACJ) dislocation (up to 2 weeks after trauma)
High grade dislocation (Rockwood III - V)
Capability of follow-up until 1 year after surgery
Exclusion criteria:
Chronic ACJ dislocation (more than 3 weeks after trauma)
Recurrent dislocation
ACJ injury type III in patients older than 65 years
Data collection is not possible for at least 1 year after surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Not 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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
South Shahid Madani St., Imam Hussein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.040
Health conditions studied
1
Description of health condition studied
Subluxation and dislocation of acromioclavicular joint
ICD-10 code
S43.1
ICD-10 code description
Subluxation and dislocation of acromioclavicular joint
Primary outcomes
1
Description
Constant Score
Timepoint
Before surgery, 6 months after surgery, 12 months after surgery
Method of measurement
survey
2
Description
The University of California Los Angeles Shoulder score
Timepoint
Before surgery, 6 months after surgery, 12 months after surgery
Method of measurement
survey
3
Description
Visual Analogue Scale
Timepoint
Before surgery, 6 months after surgery, 12 months after surgery
Method of measurement
survey
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treated with hook plate
Category
Treatment - Surgery
2
Description
Intervention group: Treated with open endobottom method
Category
Treatment - Surgery
3
Description
Intervention group: Treated with arthroscopic endobottom method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Hasan Barati
Street address
South Shahid Madani
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dr.hasan.barati@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Sahid Arabi
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Alireza Mohseni Sangtabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
South Shahid Madani
City
Tehran
Province
Tehran
Postal code
1617746510
Phone
0989109448358
Email
aalirezamohseni90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Alireza Mohseni Sangtabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
South Shahid Madani
City
Tehran
Province
Tehran
Postal code
1617746510
Phone
0989109448358
Email
aalirezamohseni90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Alireza Mohseni Sangtabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
South Shahid Madani
City
Tehran
Province
Tehran
Postal code
1617746510
Phone
0989109448358
Email
aalirezamohseni90@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data of the patients will be added as a supplement upon the request of the publication publishing the study results.
The study protocol will be presented as a method in this study's published article.
The statistical analysis roadmap will be presented in the form of the implementation method in the published article of the present study.
The informed consent form will be attached at the request of the publication publishing the study results.
The clinical study report will be published in a research paper in one of the prestigious international scientific journals.
When the research paper is published, the codes used in data analysis will be attached in the form of R or SPSS files.
When the data will become available and for how long
After the publication of the research article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is possible to copy, publish, display and perform works and derivative works only for non-commercial purposes.