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IRCT20230417057939N1 IRCT 2023-06-18 Arak University of Medical Sciences Investigating the effect of PMMA on the outcome of proximal humerus type 3 and 4 fractures Investigating the effect of polymethylmethacrylate cement in outcome of proximal humerus fractures 2023-05-12 anticipated 60 Complete https://irct.ir/trial/69723 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two intervention groups according to the order of arrival and based on the randomization sequence that will be produced in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, by using the block method random number generation software, the randomization sequence will be produced according to the required sample size for two groups. In the beginning, all the modes that can arrange 2 letters A and B in a block of 8 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. All these works will be done with a software called Sealed Envelope. Using this method, concealment will also be observed. The concept of concealment is the unpredictability of assigning people to groups. In fact, the researcher will not be able to predict which group the next person will be in, Blinding description: Single-blind - In this study, patients do not know how they are grouped and how their surgical procedures are performed, so the participants are blinded. The corresponding assistant knows how to group patients and surgical procedures. N/A Proximal humerus fractures. Intervention 1: Intervention group: Patients with type 3 and 4 proximal humerus fractures with metaphyseal defects, 500 cc of German BONOS bone cement will be used at the site of metaphyseal defects during surgery. Intervention 2: Control group: Patients with type 3 and 4 proximal humerus fractures with metaphyseal defects will not use cement, and routine surgery will be performed for patients. 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 There is no further information
public Mohamad Hosein Bakhshi
Valiasr hospital, Vali asre Blvd., Imam Khomeyni Ave.
Arak Iran (Islamic Republic of) 3819693345 +98 86 1313 6574 mhosseinbakhshi92@gmail.com Arak University of Medical Sciences scientific Mohamead Hosein Bakhshi
Valiasr hospital, Vali asre Blvd., Imam Khomeyni Ave.
Arak Iran (Islamic Republic of) 3819693345 +98 86 1313 6574 mhosseinbakhshi92@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Type 3 and 4 proximal humerus fractures with metaphyseal defects Age over 50 years Absence of chronic kidney and liver disease Absence of cancer Informed consent to participate in the study 50 years no limit Both Allergy to bone cement Death of the patient Any cardiorespiratory arrest during surgery S42.2 Fracture of upper end of humerus Treatment - Surgery Treatment - Surgery Intervention group: Patients with type 3 and 4 proximal humerus fractures with metaphyseal defects, 500 cc of German BONOS bone cement will be used at the site of metaphyseal defects during surgery. Control group: Patients with type 3 and 4 proximal humerus fractures with metaphyseal defects will not use cement, and routine surgery will be performed for patients. Infection. Timepoint: Two weeks after surgery, 1 month after surgery and 3 months after surgery. Method of measurement: Observation. Range of motion (ROM)extension; flexion; external rotation; internal rotation; abduction and adductio. Timepoint: 1 and 3 months after surgery. Method of measurement: Disabilities of the Arm, Shoulder and Hand; DASH Questioner. Avascular necrosis. Timepoint: 1 month after surgery and 3 months after surgery. Method of measurement: DASH questionnaire, graphic observation, examination. Screw back out. Timepoint: Two weeks, one month after surgery and three months after surgery. Method of measurement: Graphic observation, examination. Screw penetration. Timepoint: Two weeks, one month after surgery and three months after surgery. Method of measurement: Graphic observation, examination. Arak University of Medical Sciences Approved 2023-04-17 Ethics Committee of Arak University of Medical Sciences Sardasht Ave., Chamran Blvd., Arak Town Arak Markazi Iran (Islamic Republic of)