Evaluation of the effectiveness of platelet lysate on the recovery of knee meniscus
Design
This study is clinical trial with control group, with parallel group, single-blind, Non-randomized to Intervention and control group, phase 2 on 15 patients.
Settings and conduct
Initially, the following items will be recorded for the patients who meet the inclusion criteria: Pain by VAS, Knee function by WOMAC, Knee function by KOOS, Flexion range of motion. After platelet lysate (PL) and platelet rich plasma (PRP) preparation, patients will be referred to the Rehabilitation Department of the Shahid Madani Hospital. PRP injection will be given to patients supralaterally. The injection will be repeated twice with a 21 days apart. Then, the effect of PL and PRP on patients will be evaluated in the intervals of 1, 3, 6 and 12 months after the first injection.
Participants/Inclusion and exclusion criteria
Radiologic findings with a period of three-month symptoms of knee meniscus in both of knees. No history of knee surgery, blood disorders and confounders in the study results and no extraordinary deformation
Intervention groups
Treatment group: Platelet lysate.
Control group: Platelet rich plasma.
Main outcome variables
knee pain; knee function;; range of knee motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160422027520N18
Registration date:2020-08-25, 1399/06/04
Registration timing:prospective
Last update:2020-08-25, 1399/06/04
Update count:0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of platelet lysate therapy on knee
Public title
Treatment of knee meniscus with platelet lysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between the ages of 18 and 75 with OA diagnosis based on the American College of Rheumatology
Analog scale of knee pain (VAS) equal to or greater than 2.5
People with at least 6 months of history of meniscus in both knees
Radiological classification scale Kellgren-Lawrence 1 or 2
The availability of individual during the study period
BMI Between 20 and 35
Positive joint line tenderness test
Positive thessaly test
Exclusion criteria:
Pregnant women or women who are breastfeeding
People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, rheumatoid arthritis, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome
Those linked to acetaminophen or Vicodin or a history of drug misuse
History of cortisone injections in the last 6 weeks
The use of non-steroidal anti-inflammatory drugs 1 week ago
Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ
The use of inhibitors of platelet aggregation and anti-coagulation such as heparin
History of knee surgery in the last 3 months
Extraordinary deformation (varus >5ᵒ, valgus >5ᵒ)
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study participant will be unaware of his placement in the study group (Platelet rich plasma or platelet lysate). After obtaining informed consent and blood sampling from patients, platelet rich plasma (PRP) and platelet lysate (PL) are prepared. The patient does not know to which knee PRP or PL is injected, and only researchers and physicians know the type of blood product being injected.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
Determining knee pain by VAS in all phases of clinical trial
Timepoint
1, 3, 6 and 12 months after the first injection
Method of measurement
Questionnaire (VAS)
2
Description
Determination of knee function by WOMAC and KOOS in all phases of clinical trial
Timepoint
1, 3, 6 and 12 months after the first injection
Method of measurement
Questionnaire (WOMAC), Questionnaire (KOOS)
3
Description
Determine the range of knee motion by manual joiniometry in all phases of clinical trial
Timepoint
1, 3, 6 and 12 months after the first injection
Method of measurement
Range of motion (Degree)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fifteen patients with knee meniscus receive platelet lysate (PL) as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). In this group of patients, 10 ml of blood was taken and will be used for PL preparation. The PL is then injected by a physician into one of the two knees of the patient with knee meniscus. The injection volume of PL is 2 cc.Repeat injections twice again 21 days apart.Then, in order to evaluate the effect of PL on patients in the intervals and Compare it with another patient's knees who received platelet rich plasma, 1, 3, 6 and 12 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded.
Category
Treatment - Other
2
Description
Control group: Fifteen patients with knee meniscus receive platelet rich plasma (PRP) as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). Then 10 ml of blood was taken of patients and will be used for PRP preparation. The PRP is then injected by a physician into one of the two knees of the patient with knee meniscus. The injection volume of PRP is 2 cc.Repeat injections twice again 21 days apart.Then, in order to evaluate the effect of PRP on patients in the intervals and Compare it with another patient's knees who received platelet lysate, 1, 3, 6 and 12 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital, Tabriz
Full name of responsible person
Mehdi Yousefi, Ph.D Of Medical Immunology
Street address
Shahid Madani Hospital, Golbad Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7767
Email
mehdi_yusefi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1336 4665
Email
yousefime@tbzmed.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