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IRCT20211201053235N8 IRCT 2025-10-10 Shahid Beheshti University of Medical Sciences Management of Extra-Articular Distal-Third Humeral Fractures Comparing Anterior Minimal Invasive Plate Osteosynthesis (MIPO) with PHILOS plate and Open Reduction Internal Fixation (ORIF) with T-Locking Posterior Plate for Extra-Articular Distal-Third Humeral Fractures: A Randomized Clinical Trial 2025-03-21 anticipated 60 Recruiting https://irct.ir/trial/81626 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use ten blocks of six to allocate 60 people to two groups of 30. First, we will consider six cards, including 3 cards called group A and 3 cards called group B. As each patient enters, we randomly draw one card from the six cards and, based on the result of the card drawn, the patient is assigned to group A or B. The drawn card is discarded and the next person is assigned to two groups A or B based on the remaining five cards, and this process will continue until the sixth person. The next six people are again selected based on the six randomized cards. This process is repeated for ten blocks of six, and finally we will have two groups of 30 people from two treatments A or B, Blinding description: Blinding Method in the Study: In this study, an evaluator and observer who is unaware of the type of treatment will be used to measure the outcome variables; therefore, this study will be a single-blind study. The evaluator will be a medical professional who has no knowledge of which method the patient has undergone. Additionally, the forms and data entry checklists will avoid mentioning names to preserve the confidentiality of the type of procedure. N/A Extra-Articular Distal-Third Humeral Fractures. Intervention 1: Intervention group: Patients undergoing surgery with minimally invasive plate osteosynthesis (MIPO) using a fibula plate in a supine position under general anesthesia, with two small incisions distal and proximal to the fracture site. The plate will be inserted in a reverse manner from distal to proximal. All surgeries will be performed by a single surgeon at one center, and post-surgery, the patients will not be placed in a splint. Physical therapy will begin after suture removal at two weeks. Intervention 2: Control group: Patients undergoing surgery with open reduction and internal fixation (ORIF) using a T-plate in a lateral position under general anesthesia. In this method, a posterior skin approach is used, and after splitting the triceps, access is gained to the fracture site for reduction. The radial nerve will also be explored, and the T-plate will be placed posteriorly. These surgeries will be performed by a single surgeon at one center, and post-surgery, patients in this group will also not be placed in a splint. Physical therapy will begin after suture removal at two weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: After the project starts To whom: Everyone in the health system Conditions: Not necessary. Where to obtain: Project manager email How to obtain: Within a week Comments:
public Meisam Jafari Kafiabadi
Department of Orthopedics, School of Medicine, Shahid Beheshti University, Koodak Yaar, Daneshju, Fazlollah Street, Shahid Chamran Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1989634154 +98 21 2387 2206 meisamjafarikafiabadi@gmail.com Shahid Beheshti University of Medical Sciences scientific Meisam Jafari Kafiabadi
Department of Orthopedics, School of Medicine, Shahid Beheshti University, Koodak Yaar, Daneshju, Fazlollah Street, Shahid Chamran Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 19839-63113 +98 913 359 0400 meisamjafarikafiabadi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Acute distal humeral shaft fracture consent to participate in the study 20 years 60 years Both Open fractures having severe underlying diseases that affect the incidence of complications or union, including RA and corticosteroid use,lupus, nerve or vascular damage before surgery previous surgical history of the injured limb multiple fractures or multiple trauma patients hospitalization in the intensive care unit lack of cooperation in follow-up or patient dissatisfaction age over 60 or under 20 heavy smoking Treatment - Surgery Treatment - Surgery Intervention group: Patients undergoing surgery with minimally invasive plate osteosynthesis (MIPO) using a fibula plate in a supine position under general anesthesia, with two small incisions distal and proximal to the fracture site. The plate will be inserted in a reverse manner from distal to proximal. All surgeries will be performed by a single surgeon at one center, and post-surgery, the patients will not be placed in a splint. Physical therapy will begin after suture removal at two weeks. Control group: Patients undergoing surgery with open reduction and internal fixation (ORIF) using a T-plate in a lateral position under general anesthesia. In this method, a posterior skin approach is used, and after splitting the triceps, access is gained to the fracture site for reduction. The radial nerve will also be explored, and the T-plate will be placed posteriorly. These surgeries will be performed by a single surgeon at one center, and post-surgery, patients in this group will also not be placed in a splint. Physical therapy will begin after suture removal at two weeks. Bleeding. Timepoint: During surgery. Method of measurement: Through medical records and based on milliliters. Range of motion. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Using the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Surgical incision length. Timepoint: Post-surgery. Method of measurement: Measurement of incision length in centimeters through measurements taken during the operation. Functional Outcomes. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Using the Motor Evaluation Protocol Questionnaire. Union time. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Through radiographic imaging, considering welding, 3 cortices out of four cortices. Complications. Timepoint: Patients in the intervention and control groups are visited after surgery five times at intervals of 2, 4, and 12 weeks, and 6 and 12 months post-surgery. Method of measurement: Through examination and radiographic imaging, including cases of infection, intraoperative injuries, implant failure, and the need for reoperation. Shahid Beheshti University of Medical Sciences Approved 2025-01-19 Ethics Committee of the Skin Research Center of Shahid Beheshti University of Medical Sciences Skin Research Center, Minou Alley, Shahrdari Street, Shariati Street, Tehran Tehran Tehran Iran (Islamic Republic of)