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Investigating the amount of rotator cuff tear repair by injecting platelet-rich plasma under ultrasound guidance

Protocol summary

Study aim
Determination of rotator cuff tear repair extent through ultrasound-guided injection of platelet-rich plasma
Design
A non-randomized clinical trial, without a control group, and without blinding, phase 1, will be conducted on 40 patients.
Settings and conduct
This study will utilize patients with partial tendon tears who meet the study's inclusion criteria. Patients will be selected from the specialized Sports Medicine Clinic and, after obtaining informed consent, will participate in the study. Platelet-rich plasma will be prepared and injected under ultrasound guidance. Clinical and radiographic measurements of patients will be performed before, immediately after, and two months after injection, along with relevant sonographic evaluations. After data collection and analysis, the results will be reported in the final thesis.
Participants/Inclusion and exclusion criteria
Age range: 18 to 80 years old; Primary tear; Traumatic or degenerative tear with less than 50% thickness
Intervention groups
A clinical trial study is planned in patients with rotator cuff tears in the city of Mashhad in the year 1403. Patients will be selected from the specialized Sports Medicine Clinic and, after obtaining informed consent, will participate in the study. Inclusion criteria for the study include ages between 18 and 80 years old, tendon tear less than 50%, and willingness to participate in the study. Exclusion criteria from the study include secondary rotator cuff tear due to fracture or dislocation. Patients will receive three injections of platelet-rich plasma under ultrasound guidance, and ultrasound imaging will be performed before injection, after injection, and two months later. Data will be collected, and the study results will be reported in the final thesis.
Main outcome variables
Percentage of tear; mediolateral tear length; pain level; shoulder range of motion; tear repair

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240123060779N1
Registration date: 2024-03-20, 1403/01/01
Registration timing: prospective

Last update: 2024-03-20, 1403/01/01
Update count: 0
Registration date
2024-03-20, 1403/01/01
Registrant information
Name
Farnood Rajabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 7207
Email address
f.rajabzadeh@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the amount of rotator cuff tear repair by injecting platelet-rich plasma under ultrasound guidance
Public title
Effect of Platelet-Rich Plasma Injection on Rotator Cuff Tear Repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 18 to 80 years old Initial tear Traumatic or degenerative tear with less than 50% thickness Willingness to participate in the study
Exclusion criteria:
Secondary rotator cuff tear due to fracture or dislocation Presence of dislocation during the study period Rotator cuff tears that have previously undergone surgical repair or corrective arthroscopy Diseases associated with upper limb pain such as arthritis, infection, carpal tunnel syndrome, cervical neuropathy Localized malignancy Systemic disorders such as uncontrolled diabetes and hypothyroidism, pregnancy, platelet count less than 125,000 Having definitive disability or inability to attend for follow-up after injection
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 40
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 Committee in Research of the Medical School, Islamic Azad University, Mashhad Branch.
Street address
Saadi St., Imam Khomeini 14th St., Medical School, Islamic Azad University, Mashhad Branch
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2023-11-08, 1402/08/17
Ethics committee reference number
IR.IAU.MSHD.REC.1402.152

Health conditions studied

1

Description of health condition studied
Rotator cuff tear
ICD-10 code
M75.10
ICD-10 code description
Unspecified rotator cuff tear or rupture, not specified as traumatic

Primary outcomes

1

Description
Determination of rotator cuff tear repair extent based on changes in percentage of tear
Timepoint
Before intervention and at 2 months and 6 months post-initiation of platelet-rich plasma injection
Method of measurement
Ultrasound imaging

2

Description
Determination of rotator cuff tear repair extent based on changes in mediolateral tear length
Timepoint
Before intervention and at 2 months and 6 months post-initiation of platelet-rich plasma injection
Method of measurement
Ultrasound imaging

3

Description
Determination of rotator cuff tear repair extent based on changes in pain level
Timepoint
Before intervention and at 2 months and 6 months post-initiation of platelet-rich plasma injection
Method of measurement
Ultrasound imaging

4

Description
Determination of rotator cuff tear repair extent based on changes in shoulder range of motion
Timepoint
Before intervention and at 2 months and 6 months post-initiation of platelet-rich plasma injection
Method of measurement
Ultrasound imaging

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this clinical trial study, the intervention group consists of patients with rotator cuff tears who undergo platelet-rich plasma (PRP) injection. The PRP preparation process involves collecting blood from patients under sterile conditions and storing it in citrate-dextrose tubes. The blood is then centrifuged to separate into three layers, with the bottom layer containing the platelet-rich plasma. During the injection process, the injection site is determined using musculoskeletal ultrasound probe. Then, 2 to 3 milliliters of platelet-rich plasma are injected into the rotator cuff tear site under ultrasound guidance. Patients are positioned in a seated position during the injection. Following the injection, study patients are repeatedly assessed to observe clinical and radiological changes post-PRP injection. These changes include comparing pain levels, shoulder range of motion, defect size, percentage of tear, tendon thickness, and other parameters related to rotator cuff tear.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Atras Sports Medicine Specialty Clinic of Mashhad
Full name of responsible person
Amirhossein Feyzi
Street address
Bistoon 2, Dastgheib Street, Khayyam Intersection, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
8189992584
Phone
+98 51 3755 7000
Email
info@atrasclinic.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirhossein Feyzi
Street address
No. 55. Sadeghi 11, Sadeghi Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9184937544
Phone
+98 51 3728 8698
Email
amirhfyz96@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnood Rajabzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
No. 1, Parastar Ave., Ahmad Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9184937544
Phone
+98 51 3844 7207
Fax
Email
f.rajabzadeh@mshdiau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnood Rajabzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
No. 1, Parastar Ave., Ahmad Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9184937544
Phone
+98 51 3844 7207
Fax
Email
f.rajabzadeh@mshdiau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnood Rajabzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
No. 1, Parastar Ave., Ahmad Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9184937544
Phone
+98 51 3844 7207
Fax
Email
f.rajabzadeh@mshdiau.ac.ir

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
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