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IRCT20180714040468N1 IRCT 2019-07-20 Tabriz University of Medical Sciences medical insert in patients with osteonecrosis of the femur head Investigating the Role of Silicone Therapy on Clinical and Radiological Symptoms in Patients with Idiopathic Osteonecrosis of the Femoral Head. A Clinical Trial study. 2017-12-22 anticipated 17 Complete https://irct.ir/trial/39652 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: In this study, in coordination with other masters of Tabriz Shohada Hospital, referrals of patients, adult patients referred to the hip clinic with Femoral head ION diagnosis will be studied. First, patients who are not willing to undergo surgery will be divided into control and intervention groups. In this group In addition to all the usual therapies, shoe's insert will be prescribed, and in the the control group only the usual therapeutic will be taken. In this study, patients classified in FICAT Stage 1 and 2 will be included in the study and will not be included in patients undergoing surgery for the ION in the past year. Of course, if during the course of the study, patients in either group need to undergo a surgical procedure will do. Femoral head ION may have different causes, and patients have been suffering from this disease for several reasons, and factors such as the use of Drugs, smoking, the amount of daily activity, alcohol consumption, and various types of ION-causing illnesses are considered as confounding factors in the study. However, by random categorization of patients between the two groups, this problem will be addressed in the study In this study, each patient will be monitored and studied for one year. Due to the necessity of frequent referral to follow up, for each patient referral, the forms of HHS and FICAT will be filled in for analysis. That's why this research may require one and a half years to collect data. Shoe's insert is designed for each patient in the center of the orthosis of Tabriz Shohada Hospital. Due to the fact that the use of medical flooring is not a proven method, the cost of the treatment is costly from the patient organization It is necessary to explain that in this study, none of the patients will know about the prescribing of shoe's insert to others, and because of the interpretation of the results based on the radiographic changes in the disease and standard scores, there is no need for researchers to blind. Considering that no similar studies have ever been done in this regard, "all patients referred to the Shohada Hospital Hip Clinic will be studied within six months, and the sampling will continue until the end of the period. Subsequently, the sampling volume In this study, randomized and in the form of allocation of patients to control and intervention groups after determining the criteria for entering and leaving the study by Blind Randomization software, thus, considering the randomness of the split of the investigator's patients, the effect on the choice The two groups will not control and interact. N/A Idiopathic femoral head Osteonecrosis. Intervention 1: Intervention group: Patients prescribed for shoe inserts for them. Shoe inserts are used on both feet. shoe inserts are made of silicon and leather with a thickness of one centimeter in the heel area, which gradually decreases to Forefoot. Patients participating in the study are fully justified to use on a day to day basis. It should be noted that their exact presence during the study, in addition to accurate examination of the study, is also useful for the careful follow up of the disease and for the health of patients themselves. Intervention 2: Control group: The control group will only take the usual medical treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of the obligation to hide patient information
public Dr mahdi pashazadeh
Golshahr-elgoli
Tabriz Iran (Islamic Republic of) 5167846487 +98 41 3389 3221 Dr.m.pashazadeh.85@gmail.com Tabriz University of Medical Sciences scientific Dr.Alireza Sadegpour
Golshahr-elgoli
Tabriz Iran (Islamic Republic of) 5167846487 +98 38 93221 Dr.m.pashazadeh.85@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Dissatisfaction with surgery no limit no limit Both Failure to perform hip surgery in the past year Treatment - Devices Treatment - Devices Intervention group: Patients prescribed for shoe inserts for them. Shoe inserts are used on both feet. shoe inserts are made of silicon and leather with a thickness of one centimeter in the heel area, which gradually decreases to Forefoot. Patients participating in the study are fully justified to use on a day to day basis. It should be noted that their exact presence during the study, in addition to accurate examination of the study, is also useful for the careful follow up of the disease and for the health of patients themselves. Control group: The control group will only take the usual medical treatment Percentage of the Effect of shoe inserts on Pain Reduction and the Prevention of Clinical and Radiographic Progression in Patients with Idiopathic femoral head Osteonecrosis. Timepoint: Every 3 month until one year. Method of measurement: With FICAT and HHS standard forms. Researcher Approved 2017-12-11 Tabriz university of medical sciences Glgasht-Tabriz university of medical science Tabriz East Azarbaijan Iran (Islamic Republic of)