Evaluation of clinical results of latissimus dorsi tendon transfer to humeral head for irreparable massive rotator cuff tear
Design
This study is clinical trial is before and after. A total of 25 patients with extensive and irreparable rupture of the rotator cuff are enrolled.
Settings and conduct
The study is clinical trial is before and after. A total of 25 patients with extensive and irreparable rupture of the rotator cuff are enrolled.This study is clinical trial.Outcome elevator and analyzer are blind .Outcome elevator and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age less than 70 years, absence of osteoarthritis of the shoulder joint, patients with irreversible anthrosoprior or posterior superior rupture ,extensive and irreparable rupture of the rotator cuff
Exclusion criteria:Dissatisfaction
Intervention groups
All patients undergo shoulder surgery and transfer of the latissimus dorsi tendon to the humerus.
Main outcome variables
Shoulder rise from the front, external shoulder rotation, internal shoulder rotation, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N152
Registration date:2021-02-27, 1399/12/09
Registration timing:registered_while_recruiting
Last update:2021-02-27, 1399/12/09
Update count:0
Registration date
2021-02-27, 1399/12/09
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-31, 1399/05/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical results of latissimus dorsi tendon transfer to humeral head for irreparable massive rotator cuff tear
Public title
Evaluation of clinical results of latissimus dorsi tendon transfer to humeral head for irreparable massive rotator cuff tear
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 70 years
Absence of osteoarthritis of the shoulder joint
Patients with irreversible anthrosoprior or posterior superior rupture
Extensive and irreparable rupture of the rotator cuff
Exclusion criteria:
Dissatisfaction
Age
To 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Hamedan University Of Medical Sciences
Street address
Research Center,The beginning of Ayatollah Kashani Boulevard, Shariati Crossroad., Hamadan
City
Hamedan
Province
Hamadan
Postal code
65176-19657
Approval date
2020-07-25, 1399/05/04
Ethics committee reference number
Ir.umsha.rec.1399.411
Health conditions studied
1
Description of health condition studied
irreparable massive rotator cuff tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
Shoulder rise from the front
Timepoint
3 and 6 months after surgery
Method of measurement
Oblique
2
Description
External shoulder rotation
Timepoint
3 and 6 months after surgery
Method of measurement
Oblique
3
Description
Internal shoulder rotation
Timepoint
3 and 6 months after surgery
Method of measurement
Observation
4
Description
Pain
Timepoint
3 and 6 months after surgery
Method of measurement
Constant-Murley Shoulder Outcome Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients undergo shoulder surgery and transfer of the latissimus dorsi tendon to the humerus.In a semi-sitting position under general anesthesia with a lattice dorsopectomy approach, the dorsum shaft is detached from the front of the head to a small tuberosity with a 5-strand thread. It is then stretched. Abduction braces are taken.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Hossein Saremi
Street address
Research Center,The beginning of Ayatollah Kashani Boulevard, Shariati Crossroad., Hamadan
City
Hamedan
Province
Hamadan
Postal code
65176-19657
Phone
+98 81 3252 0182
Email
hosseinsaremi.shoulder@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Research Center,The beginning of Ayatollah Kashani Boulevard, Shariati Crossroad., Hamadan
City
Hamedan
Province
Hamadan
Postal code
65176-19657
Phone
+98 81 3252 0182
Email
hosseinsaremi.shoulder@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hossein Saremi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
The beginning of Ayatollah Kashani Boulevard, Shariati Crossroad., Hamadan
City
Hamedan
Province
Hamadan
Postal code
65176-19657
Phone
+98 81 3252 0182
Email
hosseinsaremi.shoulder@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hossein Saremi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
The beginning of Ayatollah Kashani Boulevard, Shariati Crossroad., Hamadan
City
Hamedan
Province
Hamadan
Postal code
65176-19657
Phone
+98 81 3252 0182
Email
hosseinsaremi.shoulder@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Amini
Position
medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
The beginning of Ayatollah Kashani Boulevard, Shariati Crossroad., Hamadan
City
Arak
Province
Hamadan
Postal code
65176-19657
Phone
+98 81 3252 0182
Fax
+98 81 3252 0182
Email
hosseinsaremi.shoulder@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available