Evaluation and comparison of the effect of platelet-rich plasma therapy and arthroscopic surgery on anterior cruciate ligament ligament rupture
Design
Clinical trial with control group with parallel groups, phase 2-3 on 100 patients
Settings and conduct
This study will be performed in 501 Army Hospital in Tehran. 100 patients will be divided into two groups of surgical treatment and PRP. Patients' pain and function will be measured and compared one year after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 18 and 70 years, detection of anterior cruciate ligament rupture by imaging, referring to the 501 Artesh Hospital, having the written informed consent to participate in the study
No-entry criteria:
Willingness to have surgery, lack of access to the patient
Intervention groups
Intervention group 1: Patients in this group will be treated for anterior cruciate tendon repair by arthroscopy and tendon graft.
Intervention group 2: Patients in this group will be treated with PRP. PRP treatment involves taking 40 cc of venous blood from patients in which blood samples are centrifuged and the platelet section is removed. After disinfecting the injection site, PRPs are injected into the affected joint and patients will then be treated with a hinge-knee brace.
Main outcome variables
Pain and knee function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N18
Registration date:2021-10-22, 1400/07/30
Registration timing:registered_while_recruiting
Last update:2021-10-22, 1400/07/30
Update count:0
Registration date
2021-10-22, 1400/07/30
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of platelet-rich plasma therapy and arthroscopic surgery on anterior cruciate ligament ligament rupture
Public title
Platelet-rich plasma and arthroscopic surgery for anterior cruciate ligament ligament rupture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 70 years
Detection of anterior cruciate ligament rupture by imaging
Referring to the 501 Artesh Hospital
Having the written informed consent to participate in the study
Exclusion criteria:
Willingness to have surgery
Lack of access to the patient
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 the Arteshof the of the Islamic Republic of Iran University of Medical Sciences
Street address
Artesh University of Medical Sciences, Etemadzadeh St., West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.AJAUMS.REC.1399.258
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament rupture
ICD-10 code
S83. 512A
ICD-10 code description
Sprain of anterior cruciate ligament of left knee
Primary outcomes
1
Description
Pain
Timepoint
Before and one year after interventions
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Knee function
Timepoint
Before and one year after interventions
Method of measurement
Score Knee Oxford
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group will be treated for anterior cruciate tendon repair by arthroscopy and tendon graft.
Category
Treatment - Surgery
2
Description
Intervention group 2: Patients in this group will be treated with PRP. PRP treatment involves taking 40 cc of venous blood from patients in which blood samples are centrifuged and the platelet section is removed. After disinfecting the injection site, PRPs are injected into the affected joint and patients will then be treated with a hinge-knee brace.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
501 Arthesh hospital
Full name of responsible person
Shamim Fatah
Street address
501 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
sepehr.eslami2004@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zeshk
Street address
Artesh University of Medical Sciences, Etemadzadeh St., West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8833 7920
Email
Yousefi.Zeshk@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Shamim Fatah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
501 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
sepehr.eslami2004@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shamim Fatah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
501 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
sepehr.eslami2004@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shamim Fatah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
501 Artesh hospital, End of Oshan Boulevard, Arthesh Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
sepehr.eslami2004@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
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Artesh University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.