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IRCT20221116056519N1 IRCT 2022-12-18 Tehran University of Medical Sciences Tourniquet effects on knee joint replacement Comparison of amount of bone cement penetration and short-term outcomes in total knee arthroplasty with and without the use of tourniquets 2022-11-29 anticipated 60 Complete https://irct.ir/trial/67048 observational Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization by the method of 2 blocks and individually by the site randomization.com, done by a person outside the study and informed to the operating room personnel without the surgeon's knowledge, Blinding description: Randomization is done by a third person outside the study, and on the day of the surgery, another person outside the surgery, who is from the operating room staff, is informed, and the data is performed by another third party. It is collected without the knowledge of the surgeon. Data analysis is done by another person who is outside the study in 2 separate groups without knowing the type of intervention. At the beginning of the study, the type of intervention was explained to all patients, and consent was obtained, but the patient was unaware of the type of randomization. N/A The amount of cement penetration, the amount of bleeding after surgery, pain after surgery, the function of muscles around the knee after surgery, the amount of knee ROM after surgery, the relationship between BMD and cement penetration in TKA. Intervention 1: Intervention group: patients who do not use a tourniquet to perform TKA. ZIMMER and DEPUY prostheses are used. Patients are examined for muscle strength, knee joint range of motion, and bone density measurements. Check HB. Intervention 2: Control group: patients who use a tourniquet to perform TKA. ZIMMER and DEPUY prostheses are used. Patients are examined for muscle strength, knee joint range of motion, and bone density measurements. They are also subjected to a CBC test. Check HB. Yes - There is a plan to make this available What will be shared: After de-identifying people, the entire data can be shared and published as a file When: The access period starts 9 months after the results are published To whom: People working in academic and scientific centers will have access to the file Conditions: The data are for designing future studies and are allowed to be used Where to obtain: hesan rezaee 00989128651586 hesan.rezaee@gmail.com How to obtain: Along with the request, a summary of the academic and professional degree and the university center where the student is employed should be sent. The data file will be sent within 2 weeks at most. Comments:
public Hesan Rezaee
no 26, Mohammadi St, Amirloo Ave, Towhid square
Tehran Iran (Islamic Republic of) 1419743375 +98 21 2214 7706 hesan.rezaee@gmail.com Tehran University of Medical Sciences scientific Hesan Rezaee
No26,mohammadi st,amirloo st , Tohid square, tehran
Tehran Iran (Islamic Republic of) 1419743375 +98 21 2169 2614 hesan.rezaee@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis and confirmation of indications for total knee arthroplasty surgery 55 to 85 years old BMI < 45 osteoarthritis with 3 score in kellgren and lawrence ASA score 1 or 2 TKA with Nextgen Zimmer Biomet or DePuy prosthesis primary TKA 55 years 85 years Both previous knee fracture or surgery malignancy rheumatoid diseases cardiovascular diseases infectious diseases neurologic diseases hepatic failure disease coagulopathy disorders glucocorticoid or heparin or warfarin consumption previous history of DVT or PTE neuromuscular diseases M17 Osteoarthritis of knee Treatment - Surgery Treatment - Surgery Intervention group: patients who do not use a tourniquet to perform TKA. ZIMMER and DEPUY prostheses are used. Patients are examined for muscle strength, knee joint range of motion, and bone density measurements. Check HB. Control group: patients who use a tourniquet to perform TKA. ZIMMER and DEPUY prostheses are used. Patients are examined for muscle strength, knee joint range of motion, and bone density measurements. They are also subjected to a CBC test. Check HB. Comparing the amount of cement penetration around the prosthesis in patients who undergo TKA surgery with and without the use of a tourniquet. Timepoint: 60 days after surgery, AP and LAT radiographs of the knee were taken, and based on the criteria of the Knee Society Radiographic Evaluation System, cement penetration was calculated in millimeters. Method of measurement: According to the Knee Society Radiographic Evaluation System in AP/Lat radiographs of the knee. Hemoglobin reduction rate after surgery. Timepoint: Hemoglobin level is measured before surgery and then on days 1, 7, 14, 60. Method of measurement: Based on cbc test and in gr/dl. Body size changes. Timepoint: It is measured before surgery and then on days 1, 7, 14, 60. Method of measurement: In 2 places, 5 cm above the medial malleolus and 10 cm above the superior patella, the limb circumference is measured. Knee range of motion. Timepoint: It is measured before surgery and then on days 1, 7, 14, 60. Method of measurement: in degrees and using goniometr. Knee pain. Timepoint: It is measured before surgery and then on days 1, 7, 14, 60. Method of measurement: Based on the Visual Analogue Scale. Strength of knee extensor and flexor muscles. Timepoint: It is measured before surgery and then on days 1, 7, 14, 60. Method of measurement: Clinical examination of muscle strength. Post operation complications. Timepoint: Day 1,7,14,60. Method of measurement: Presence or absence of dvt/pte/bleeding/infection. Tehran University of Medical Sciences Approved 2022-07-19 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences imam khomeini hospital,doctor gharib street,keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)