Clinical evaluation on acromioclavicular joint dislocations; A) Ethibond suture peri-clavicular loop vs B) Ethibond suture through two holes in clavicle
(1) Objectives: to compare the therapeutic effects of two different techniques in the treatment of ACJ dislocation
(2) Design: Randomized controlled trial.
(3) Setting and conduct: Sample size of 76 patients will randomly assign into A) Ethibond suture peri-clavicular loop vs B) Ethibond suture through two holes in clavicle and will be treated in academic orthopedic hospital.
(4) Participants: Inclusion criteria: patients with: age>18 years, clinically and radiographically diagnosed as acute acromioclavicular joint dislocation (in the first 3 weeks) with grade III-VI .
Exclusion criteria: age>65 years, chroninc dislocation, history of previous shoulder trauma, concomitant lesion in the suffered arm.
(5) Interventions: A) Ethibond suture peri-clavicular loop vs B) Ethibond suture through two holes
(6) Main outcome measures: Primary outcome is horizontal displacement status of radiography of the acromioclavicular joint
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704087274N12
Registration date:2017-04-12, 1396/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation on acromioclavicular joint dislocations; A) Ethibond suture peri-clavicular loop vs B) Ethibond suture through two holes in clavicle
Public title
Shoulder joint dislocation surgeries: a comparison between two techniques
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with: age>18 years, clinically and radiographically diagnosed as acute acromioclavicular joint dislocation (in the first 3 weeks) with grade III-VI .
Exclusion criteria: age>65 years, chroninc dislocation, history of previous shoulder trauma, concomitant lesion in the suffered arm.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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, Guilan University of Medical Sciences
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Postal code
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.GUMS.REC.1395.307
Health conditions studied
1
Description of health condition studied
Dislocation of acromioclavicular joint
ICD-10 code
S43.1
ICD-10 code description
Dislocation of acromioclavicular joint
Primary outcomes
1
Description
Horizontal status of radiography of the acromioclavicular joint
Timepoint
pre-operation visit, three, six and twelve monthes foloow ups
Method of measurement
using a ruler with milimeter
Secondary outcomes
1
Description
Functional shouldet status
Timepoint
Pre-operation, third, sixth, and twelve monthes follow ups
Method of measurement
Taft score
2
Description
Functional shouldet status
Timepoint
Pre-operation, third, sixth, and twelve monthes follow ups
Method of measurement
Constant score
3
Description
Functional shouldet status
Timepoint
Pre-operation, third, sixth, and twelve monthes follow ups
Method of measurement
Acromioclavicular joint instability score
Intervention groups
1
Description
Group A (AC joint repair using two holes):
In this group the Ethibond-5 suture will be folded and will be pass underneath the coracoid process and it will be pass through two holes which will be created in the clavicle. after acromioclavicular joint reduction the suture will be knotted.
Category
Treatment - Surgery
2
Description
In the second group, instead of passing the suture anchor through holes, it will be looped around the clavicle and coracoid. After reducing the acromioclavicular joint, the anchore suture will be knotted