1- evaluation the effect of platelet-rich plasma injection during arthroscopic surgery
Design
The simple random allocation method is that the intervention group (platelet-rich plasma) will be given odd numbers from the beginning, and the control group (without platelet-rich plasma injection) will be given even numbers. Each number is written on a card and placed in an envelope, the envelopes are sealed and the patient's name is written on each envelope. Each patient is given an envelope in order of numbers. Registration of patients and their allocation in each of the groups is done by someone other than the doctor.
Settings and conduct
For one group, PRP injection was performed, and in this method, the patient had one PRP injection during the arthroscopy operation. In this group, 20 cc of venous blood was taken. In this case, 3 cc of liquid containing platelets with a concentration of 5 to 6 times will be obtained. Came. Then, during arthroscopic surgery, it is injected in the shoulder at the site of injury. In the other group, PRP injection is not performed during arthroscopic surgery. This study is conducted in the orthopedic department of Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
inclusion criteria : age between 18 and 70 years old
symptoms of rotator cuff tears
MRI findings of minor to medium rotator cuff tears
exclusion criteria: a history of shoulder surgery, achronic dislocation
pregnant or lactating women
rheumatoid arthritis
gout
blood diseases
severe cardiovascular dis-eases
infections
immunodepression
patients receiving anticoagulant therapy
Intervention groups
In the intervention group, PRP injection is performed after obtaining 20 cc of blood during arthroscopic surgery.
Main outcome variables
range of motion and strength of internal and external rotation of the shoulder, pain, ultrasound findings
General information
Reason for update
Acronym
PRP
IRCT registration information
IRCT registration number:IRCT20220803055610N2
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Nima Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1690
Email address
mahdieh.ghiasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Role of Platelet-Rich Plasma in Shoulder Rotator Cuff Repair With Arthroscopy
Public title
Investigating the Effect of Platelet-Rich Plasma in Arthroscopy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 and 70 years old
symptoms of rotator cuff tears
MRI findings of minor to medium rotator cuff tears
Exclusion criteria:
a history of shoulder surgery, achronic dislocation or pyogenic infection, or rotator cuffarthropathy with glenohumeral osteoarthritis
a large ormassive tear (anteroposterior size > 30 mm) during surgery
pregnant or lactating women
rheumatoid arthritis
gout
blood diseases
severe cardiovascular dis-eases
infections
immunodepression
patients receiving anticoagulant therapy
patients with haemoglobin values < 11 g/dl and platelet values < 150, 000/mm 3.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referred to the orthopedic department with the diagnosis of rotator cuff tendon injuries, which are small and medium tears, are selected by an orthopedic specialist by MRI examination and examinations based on the VAS index and shoulder function. Then the relevant questionnaires are completed. Patients are divided into two groups according to the table of random numbers, the first group is injected with PRP during arthroscopic surgery and the second group is performed alone. In two groups, after 3 and 8 weeks and 3 and 6 months, the patients are examined by performing examinations and completing the questionnaire again.
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 Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran,Tehran Medical sciences,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.037
Health conditions studied
1
Description of health condition studied
Small and medium rotator cuff tears of the shoulder
ICD-10 code
M65-M68
ICD-10 code description
Small and medium rotator cuff tears of the shoulder
Primary outcomes
1
Description
Pain
Timepoint
Every 2 weeks to eight weeks
Method of measurement
VAS score
2
Description
Range of motion
Timepoint
Every two weeks to three months
Method of measurement
Goniometer
3
Description
Ultrasound Findings
Timepoint
At the beginning of the study and after 3 months
Method of measurement
Ultrasound probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After confirming the diagnosis and referring to the orthopedic department, the patients are randomly divided into two groups. For one group, PRP injection was performed, in which the prepared prp is injected in the shoulder area during arthroscopic surgery, and the changes created during 6 months after the end of the injection are measured. In this group, 20 cc of venous blood is taken and the blood sample is separated from the platelet-rich plasma by the Selex centrifuge under the RCF protocol. After 8 weeks, all investigations, including the amount of pain, function, and ultrasound changes, are repeated and a comparison is made between the clinical and paraclinical symptoms of the patient before and after the intervention.
Category
Treatment - Drugs
2
Description
Control group: In the control group, only arthroscopic surgery is performed and PRP is not injected.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthopedics, Imam Khomeini Hospital,
Full name of responsible person
Nima Bagheri
Street address
Department of orthopedic, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1690
Email
nimab1360@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
Assistant Researcher, Central Headquarters of Tehran University of Medical Sciences, Keshavarz Blvd., Qods
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 81631
Email
nimab1360@gmail.com
Grant name
The research assistant of Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nima Bagheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1690
Email
nimab1360@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Bagheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1690
Email
nimab1360@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Bagheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Keshavarz Blvd., Qods Corner, Tehran University of Medical Sciences Headquarters,Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6658 1690
Email
mahdieh.ghiasi@yahoo.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
No - There is not 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
Data will be shared after de-identifying individuals on pain, range of motion, shoulder function, and tendon thickness.
When the data will become available and for how long
12 months after the results are published
To whom data/document is available
For researchers and workers in academic centers
Under which criteria data/document could be used
For use in research or essays
From where data/document is obtainable
by e-mail or mobile and request on the research gate website
What processes are involved for a request to access data/document
It will be sent to the applicant by email 3 months after the request