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IRCT20190508043524N1 IRCT 2019-08-11 Arak University of Medical Sciences Comparative results of bioabsorbable screw and endobutton femoral fixation of bone patellar tendon bone graft for Anterior cruciate ligament reconstruction Comparative results of bioabsorbable screw and endobutton femoral fixation of bone patellar tendon bone graft for Anterior cruciate ligament reconstruction 2018-12-16 anticipated 42 Complete https://irct.ir/trial/39914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in two groups A and B. In this method, we selected a number of cards or letters as an intervention and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size.‏, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor. N/A Anterior cruciate ligament reconstruction. Intervention 1: Intervention group 1:We will do surgery patients with endobutton femoral fixation . Intervention 2: Intervention group 2:We will do surgery patients with bioabsorbable screw femoral fixation . Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: researcher in university Conditions: If there are additional questions Where to obtain: Dr Hadi Valiasr Hospital, Valiasr squre, Shahid Shirodi street 3814957558 How to obtain: Contact With Dr Hadi at the following email address. Hadi@arakmu.ac.ir Comments:
public Dr Hosseinali Hadi
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 hadi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Hosseinali Hadi
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 hadi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Over 15 years old Candidate for surgical reconstruction of cruciate ligament Anterior cruciate ligament rupture that has no history of previous surgery on the knee The knee of the leg is correct. Anterior cruciate ligament rupture is confirmed by a clinical examination and MRI 15 years no limit Both Dissatisfaction Patients who have suffered from knee surgery. Psychiatric patients or severely addicted patients M23.61 Other spontaneous disruption of anterior cruciate ligament of knee Treatment - Surgery Treatment - Surgery Intervention group 1:We will do surgery patients with endobutton femoral fixation . Intervention group 2:We will do surgery patients with bioabsorbable screw femoral fixation . Physical problems of the knee. Timepoint: Before surgery and 12 months after surgery. Method of measurement: lysholm score. Objective surgical outcome. Timepoint: Before surgery and 12 months after surgery. Method of measurement: KDLC score. Subjective surgical outcome. Timepoint: Before surgery and 12 months after surgery. Method of measurement: KDLC score. Arak University of Medical Sciences Approved 2018-12-12 Ethics committee Arak University Of Medical Sciences Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, A Arak Markazi Iran (Islamic Republic of)