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IRCT20160422027520N18 IRCT 2020-08-25 Tabriz University of Medical Sciences Treatment of knee meniscus with platelet lysis The effects of platelet lysate therapy on knee 2020-09-05 anticipated 15 Complete https://irct.ir/trial/50258 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 2 Knee meniscus. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mehdi Yousefi
Department of Immunology, Tabriz University of Medical Sciences, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 1336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mehdi Yousefi
Department of Immunology, Tabriz University of Medical Sciences, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 1336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both 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) M23.005 Cystic meniscus, unspecified medial meniscus, unspecified knee Treatment - Other Treatment - Other 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. 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. 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). 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). 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). Tabriz University of Medical Sciences Approved 2020-08-10 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences , Daneshghah st, Tabriz, Tabriz East Azarbaijan Iran (Islamic Republic of)