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IRCT20211016052782N1 IRCT 2021-11-22 Iran University of Medical Sciences The effect of platelet rich plasma on MRI findings among patients with knee osteoarthritis A Comparative Study of changes in knee MRI findings after single and double Centrifuged platelet rich plasma and placebo (normal saline injection) in Patients with Knee Osteoarthritis: A Controlled Randomized Trial with a six-Month Follow –up 2021-12-06 anticipated 45 Complete https://irct.ir/trial/59479 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients in treatment groups using block randomization method with blocks of size six in one of the treatment groups will be as follows: A table of random numbers will be used to arrange the blocks. For this purpose, one of the blocks is selected by chance using table of random numbers and the patients are injected according to the proposed group in the block, respectively, and then the blocks are moved forward in sequence, and this process continues until the end of sampling. Group A is single Centrifuged group, group B is double Centrifuged, group C is a placebo group (normal saline). A: SS (single spin) B: DS (double spin) C: P (placebo) -Block1: AABBCC -Block2: ABCABC -Block3: CCBBAA -Block4: CBACBA -Block5: ABCCBA -Block6: CBAABC, Blinding description: In this study, the following people will be blind of the treatment groups of patients: Patients in the study only know that they are being injected and will not know the number of centrifuges performed. Also, in this study, injectable interventions are performed under the supervision of a sports medicine specialist, who is not aware of the number of centrifuges performed and only injects the solution into the joint. The researcher also does not know which MRI belongs to which injection group - Assessor Clinician: Assessments before and after interventions in the Sports Medicine Clinic will be performed by a sports medicine resident other than the researcher who does not know the presence of patients in the groups. MRI data and changes are also reviewed by two radiologists who are unaware of the patient groups - Statistical Consultant and Analyzer: Analysis of research data will be performed by a statistical consultant who is not aware of patient groups. N/A Knee Osteoarthritis. Intervention 1: Intervention group 1: The Group which treated by injection of platelet-rich plasma extracted single centrifuged. One week before the injection, an MRI of the patient's affected knee is performed at the MRI imaging center of Rasoul Akram Hospital. MRI of the knee will be performed by 1.5 T device with annular coil of the knee and in fat suppressed sequences of coronal, sagittal and axial PD and T1, T2 sagittal before and 6 months after treatment. MRI will be performed by two radiologists with experience in organ imaging who are unaware of the patient group and will examine and record cartilage thickness, joint space narrowing, the presence of osteophytes and subcutaneous cysts, and subcutaneous sclerosis.Preparation of PRP solution and injection will be done in the sports medicine clinic of Hazrat Rasool Akram Hospital. Patients are asked to discontinue anticoagulants and aspirin (if any) with their doctor's permission the week before the injection. To prepare PRP, kits (Arya Mabna Tashkis Corporation, RN: 312569, Rooyagen Kit) are used which have a completely sterile pack. To prepare the injection solution, 35 cc of intravenous blood from the upper limb will be taken from the patients by a 50 cc syringe in which 5 cc of anticoagulant solution had already been drawn, and with the help of an 18 G needle-shaped blood transfusion adapter without any pressure on the piston into the four Sterile tube is transferred. At the same time, about 0.5 cc of the patient's blood will be sent to the laboratory of Hazrat Rasool Akram Hospital to check the amount of blood cells. All 4 tubes are filled in balance and placed in a centrifuge and rotated at 1600 RPM for 10 minutes, then they are taken out. In the group, the upper half of the isolated plasma centrifuge will be removed from all four tubes and only the lower half of the plasma will be used for injection. About 5 cc of the PRP solution prepared for injection into the 5 cc syringe is drawn with a 14G needle tip and about 0.5 cc is separated again to be sent to the laboratory. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients don't put weight on injected knee and doing strenuous activity for 48 hours after the injection. One of the most important ways to treat patients with osteoarthritis of the knee is to use exercise therapy. A common exercise protocol will be prescribed for patients with osteoarthritis of the knee participating in this study. Six months after the injection, an MRI of the affected knee is taken again at the MRI imaging center of Rasoul Akram Hospital And changes are evaluated. Intervention 2: Intervention group 2: The Group which treated by injection of platelet-rich plasma extracted double centrifuged. One week before the injection, an MRI of the patient's affected knee is performed at the MRI imaging center of Rasoul Akram Hospital. MRI of the knee will be performed by 1.5 T device with annular coil of the knee and in fat suppressed sequences of coronal, sagittal and axial PD and T1, T2 sagittal before and 6 months after treatment. MRI will be performed by two radiologists with experience in organ imaging who are unaware of the patient group and will examine and record cartilage thickness, joint space narrowing, the presence of osteophytes and subcutaneous cysts, and subcutaneous sclerosis. Preparation of PRP solution and injection will be done in the sports medicine clinic of Hazrat Rasool Akram Hospital. Patients are asked to discontinue anticoagulants and aspirin (if any) with their doctor's permission the week before the injection. To prepare PRP, kits (Arya Mabna Tashkis Corporation, RN: 312569, Rooyagen Kit) are used which have a completely sterile pack. To prepare the injection solution, 35 cc of intravenous blood from the upper limb will be taken from the patients by a 50 cc syringe in which 5 cc of anticoagulant solution had already been drawn, and with the help of an 18 G needle-shaped blood transfusion adapter without any pressure on the piston into the four Sterile tube is transferred. At the same time, about 0.5 cc of the patient's blood will be sent to the laboratory of Hazrat Rasool Akram Hospital to check the amount of blood cells. All 4 tubes are filled in balance and placed in a centrifuge and rotated at 1600 RPM for 10 minutes, then they are taken out. In this group, the plasma separated by the first centrifuge are drawn into the tubes and poured into two other 10 cc sterile tubes inside the box containing 0.6 cc of preservative with anti-platelet aggregation solution. It is then re-inserted and centrifuged at 3500RPM for 6 minutes. Then 3 cc end of each 2 tubes after removing the upper plasma is drawn by 5 cc syringe with 14G needle head and about 0.5 cc is separated for sending to laboratory. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients don't put weight on injected knee and doing strenuous activity for 48 hours after the injection. One of the most important ways to treat patients with osteoarthritis of the knee is to use exercise therapy. A common exercise protocol will be prescribed for patients with osteoarthritis of the knee participating in this study. Six months after the injection, an MRI of the affected knee is taken again at the MRI imaging center of Rasoul Akram Hospital and changes are evaluated. Intervention 3: Control group: Therapeutic group with normal saline injection as a placebo group. One week before the injection, an MRI of the patient's affected knee is performed at the MRI imaging center of Rasoul Akram Hospital. MRI of the knee will be performed by 1.5 T device with annular coil of the knee and in fat suppressed sequences of coronal, sagittal and axial PD and T1, T2 sagittal before and 6 months after treatment. MRI will be performed by two radiologists with experience in organ imaging who are unaware of the patient group and will examine and record cartilage thickness, joint space narrowing, the presence of osteophytes and subcutaneous cysts, and subcutaneous sclerosis. In this group, 5 cc of normal saline will be injected as a placebo after blood sampling. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients don't put weight on injected knee and doing strenuous activity for 48 hours after the injection. One of the most important ways to treat patients with osteoarthritis of the knee is to use exercise therapy. A common exercise protocol will be prescribed for patients with osteoarthritis of the knee participating in this study. Six months after the injection, an MRI of the affected knee is taken again at the MRI imaging center of Rasoul Akram Hospital and changes are evaluated. Yes - There is a plan to make this available What will be shared: IPD collection for the primary and secondary outcomes When: Immediately after publication To whom: People working in academic institution Conditions: A reasonable request from an academic source will be responded within 10 working days. Where to obtain: Mostafa Ghadamzadeh How to obtain: After sending an email by individuals or academic centers to the researcher, after confirming the data will be provided to them Comments:
public Mostafa Ghadamzadeh
Rasool-e-Akram Hospital, Niyayesh avenue, Sattarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 9947 ghadamzadeh.m@iums.ac.ir Iran University of Medical Sciences scientific Mostafa Ghadamzadeh
Rasool-e-Akram Hospital, Niyayesh avenue, Sattarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 9947 ghadamzadeh.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with grade 2 or 3 primary osteoarthritis of the knee as determined by the Kellgren and Lawrence criteria (knee pain, morning stiffness less than 30 minutes, crepitus on movement and radiological signs of osteoarthritis include joint space loss, subchondral bone sclerosis and the formation of osteophytes in knee) Patients aged 50-75 years Patients who have persistent knee pain for at least six months and with an intensity of at least 4 according to the VAS scale in activities such as going up and down stairs, sitting for long periods and squatting Patients who are able to walk independently for at least 30 meters Patients with a body mass index equal to or less than 35 The patient has full consent to participate in the study The patient has a balanced mental state 50 years 75 years Both The patient has any contraindications for MRI, including aneurysm clips, pacemakers, metal devices in the body, and claustrophobia The patient has a history of intra-articular injection in the knee during the last six months The patient has neuromuscular diseases The patient has a history of acute traumatic injury to other ligaments and structures of the knee joint with the approval of a specialist The patient has a history of surgery or previous injury in the knee and other lower limb joints over the last year The patient has bone implants The patient has a new fracture in the lower extremities during the last year The patient has malignant tumors The patient has participated in exercise therapy and physiotherapy programs during the last three months M17 Osteoarthritis of knee Treatment - Other Treatment - Other Placebo Intervention group 1: The Group which treated by injection of platelet-rich plasma extracted single centrifuged. One week before the injection, an MRI of the patient's affected knee is performed at the MRI imaging center of Rasoul Akram Hospital. MRI of the knee will be performed by 1.5 T device with annular coil of the knee and in fat suppressed sequences of coronal, sagittal and axial PD and T1, T2 sagittal before and 6 months after treatment. MRI will be performed by two radiologists with experience in organ imaging who are unaware of the patient group and will examine and record cartilage thickness, joint space narrowing, the presence of osteophytes and subcutaneous cysts, and subcutaneous sclerosis.Preparation of PRP solution and injection will be done in the sports medicine clinic of Hazrat Rasool Akram Hospital. Patients are asked to discontinue anticoagulants and aspirin (if any) with their doctor's permission the week before the injection. To prepare PRP, kits (Arya Mabna Tashkis Corporation, RN: 312569, Rooyagen Kit) are used which have a completely sterile pack. To prepare the injection solution, 35 cc of intravenous blood from the upper limb will be taken from the patients by a 50 cc syringe in which 5 cc of anticoagulant solution had already been drawn, and with the help of an 18 G needle-shaped blood transfusion adapter without any pressure on the piston into the four Sterile tube is transferred. At the same time, about 0.5 cc of the patient's blood will be sent to the laboratory of Hazrat Rasool Akram Hospital to check the amount of blood cells. All 4 tubes are filled in balance and placed in a centrifuge and rotated at 1600 RPM for 10 minutes, then they are taken out. In the group, the upper half of the isolated plasma centrifuge will be removed from all four tubes and only the lower half of the plasma will be used for injection. About 5 cc of the PRP solution prepared for injection into the 5 cc syringe is drawn with a 14G needle tip and about 0.5 cc is separated again to be sent to the laboratory. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients don't put weight on injected knee and doing strenuous activity for 48 hours after the injection. One of the most important ways to treat patients with osteoarthritis of the knee is to use exercise therapy. A common exercise protocol will be prescribed for patients with osteoarthritis of the knee participating in this study. Six months after the injection, an MRI of the affected knee is taken again at the MRI imaging center of Rasoul Akram Hospital And changes are evaluated Intervention group 2: The Group which treated by injection of platelet-rich plasma extracted double centrifuged. One week before the injection, an MRI of the patient's affected knee is performed at the MRI imaging center of Rasoul Akram Hospital. MRI of the knee will be performed by 1.5 T device with annular coil of the knee and in fat suppressed sequences of coronal, sagittal and axial PD and T1, T2 sagittal before and 6 months after treatment. MRI will be performed by two radiologists with experience in organ imaging who are unaware of the patient group and will examine and record cartilage thickness, joint space narrowing, the presence of osteophytes and subcutaneous cysts, and subcutaneous sclerosis. Preparation of PRP solution and injection will be done in the sports medicine clinic of Hazrat Rasool Akram Hospital. Patients are asked to discontinue anticoagulants and aspirin (if any) with their doctor's permission the week before the injection. To prepare PRP, kits (Arya Mabna Tashkis Corporation, RN: 312569, Rooyagen Kit) are used which have a completely sterile pack. To prepare the injection solution, 35 cc of intravenous blood from the upper limb will be taken from the patients by a 50 cc syringe in which 5 cc of anticoagulant solution had already been drawn, and with the help of an 18 G needle-shaped blood transfusion adapter without any pressure on the piston into the four Sterile tube is transferred. At the same time, about 0.5 cc of the patient's blood will be sent to the laboratory of Hazrat Rasool Akram Hospital to check the amount of blood cells. All 4 tubes are filled in balance and placed in a centrifuge and rotated at 1600 RPM for 10 minutes, then they are taken out. In this group, the plasma separated by the first centrifuge are drawn into the tubes and poured into two other 10 cc sterile tubes inside the box containing 0.6 cc of preservative with anti-platelet aggregation solution. It is then re-inserted and centrifuged at 3500RPM for 6 minutes. Then 3 cc end of each 2 tubes after removing the upper plasma is drawn by 5 cc syringe with 14G needle head and about 0.5 cc is separated for sending to laboratory. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients don't put weight on injected knee and doing strenuous activity for 48 hours after the injection. One of the most important ways to treat patients with osteoarthritis of the knee is to use exercise therapy. A common exercise protocol will be prescribed for patients with osteoarthritis of the knee participating in this study. Six months after the injection, an MRI of the affected knee is taken again at the MRI imaging center of Rasoul Akram Hospital and changes are evaluated. Control group: Therapeutic group with normal saline injection as a placebo group. One week before the injection, an MRI of the patient's affected knee is performed at the MRI imaging center of Rasoul Akram Hospital. MRI of the knee will be performed by 1.5 T device with annular coil of the knee and in fat suppressed sequences of coronal, sagittal and axial PD and T1, T2 sagittal before and 6 months after treatment. MRI will be performed by two radiologists with experience in organ imaging who are unaware of the patient group and will examine and record cartilage thickness, joint space narrowing, the presence of osteophytes and subcutaneous cysts, and subcutaneous sclerosis. In this group, 5 cc of normal saline will be injected as a placebo after blood sampling. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients don't put weight on injected knee and doing strenuous activity for 48 hours after the injection. One of the most important ways to treat patients with osteoarthritis of the knee is to use exercise therapy. A common exercise protocol will be prescribed for patients with osteoarthritis of the knee participating in this study. Six months after the injection, an MRI of the affected knee is taken again at the MRI imaging center of Rasoul Akram Hospital and changes are evaluated. Knee MRI Changes Based on MRI Osteoarthritis Knee Score (MOAKS). Timepoint: Before the intervention and six months after the intervention. Method of measurement: Using the PACS system. Knee function with WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) scale. Timepoint: Before the intervention and one month and three months after the intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Feeling knee pain by Visual Analogue Scale (VAS). Timepoint: Before the intervention and one month and three months after the intervention. Method of measurement: Visual Analogue Scale (VAS). Knee range of motion. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Goniometry. Timed Up & Go test: The ability of a person to get up from a chair over a distance of 3 meters. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Stopwatch (seconds). Six Minute Walk test: The person's ability to walk for 6 minutes. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Distance measurement (meter). Stair climbing test: The ability of a person to climb stairs to reach the stage of pain or fatigue. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: The number of steps taken. Iran University of Medical Sciences Approved 2021-07-03 Iran University of Medical Sciences Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)