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IRCT20180306038971N1 IRCT 2020-05-22 Shahid Beheshti University of Medical Sciences Examination of arthroscopic and fluoroscopic assisted methods in the treatment of intra-articular fracture of distal radius Comparison of the functional and radiological outcomes of arthroscopic-assisted (AA) and fluoroscopic-assisted (FA) reduction of Intra-articular fracture of distal radius 2020-05-21 anticipated 60 Complete https://irct.ir/trial/47714 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization for 2 intervention groups. The randomization method will done using software, 30 random numbers for each intervention group. The researcher can not play a role in predicting treatment of the disease, and choosing the type of treatment. random sequence will generate by software. Group 1: 30 Cases and Group 2: 30 cases, Blinding description: To compare the functional outcomes of two methods, patients are examined by an orthopedist who is unaware of their surgical procedure in the 3rd and 12th months after surgery, while wearing long gloves or stockinette. N/A Intra-articular fracture of distal radius. Intervention 1: Intervention group: Based on the surgeon's decision, patients may have undergone open reduction and internal fixation (ORIF) with volar locking plate (VLP) and then additional arthroscopic assisted reduction (AAR), or AAR using the multiple pinning. Intervention 2: Control group: Patients will be undergone surgery with ORIF using VLP under the fluoroscopic control. Yes - There is a plan to make this available What will be shared: All data can be shared potentially after patients became unrecognizable. When: After completing the results and analyzing the data, access to them is allowed. To whom: This is only available for people working in academic institutions Conditions: After obtaining written permission, the use of the data is permitted with reference to the source. Where to obtain: Orthopaedic ward in Taleghani hosopital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway. Tell: 00982123031216 Mohammad Ali Okhovat Pour Tell:00982123031294 e-mail: okhovatpour@gmail.com Yaser Safaei Tell:00989155113937 e-mail: yasersafa@yahoo.com How to obtain: After completing the results and analyzing the data, the use of the data is allowed after the written request. Comments:
public Mohammad Ali Okhovat Pour
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1294 okhovatpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Ali Okhovat Pour
Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2303 1294 okhovatpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Intra-articular fracture of distal radius (AO/OTA type B3,C) Age over 18 years 18 years no limit Both Open fractures: type 2 and above according to the Gustilo-Anderson classification Concomitant fracture of the ipsilateral upper extremity or the other wrist except the ulnar styloid process fracture Neurovascular alteration such as acute carpal tunnel syndrome Compartment syndrome Previous limitation of movement in the wrist due to neuromuscular diseases or untreated nonunion or malunion of the wrist bones, or other injuries which interfered with the next rehabilitation program The need to use a dorsal plate to fix the fracture Treatment - Surgery Treatment - Surgery Intervention group: Based on the surgeon's decision, patients may have undergone open reduction and internal fixation (ORIF) with volar locking plate (VLP) and then additional arthroscopic assisted reduction (AAR), or AAR using the multiple pinning. Control group: Patients will be undergone surgery with ORIF using VLP under the fluoroscopic control Comparison of the effect of surgical procedure on postoperative disability. Timepoint: 3rd and 12th months in postoperative follow-up. Method of measurement: Patient-rated wrist/hand evaluation (PRWHE) questionnaire. Comparison of the effect of surgical procedure on extra-articular displacement, including radial inclination, radiocarpal tilt and ulnar variance. Timepoint: 12th months in postoperative follow-up. Method of measurement: Anteroposterior (AP) and lateral (LAT) wrist radiographs. Comparison of the effect of surgical procedure on scapholunate (SL) and capitolunate (CL) angle. Timepoint: 12th months in postoperative follow-up. Method of measurement: LAT wrist radiography. Comparison of the effect of surgical procedure on intra-articular displacement, including gap and step-off. Timepoint: 12th months in postoperative follow-up. Method of measurement: Wrist CT-scan. Comparison of the effect of surgical procedure on postoperative pain. Timepoint: 3rd and 12th months in postoperative follow-up. Method of measurement: Visual analogue scale (VAS) questionnaire. Comparison of the effect of surgical procedure on postoperative disability. Timepoint: 3rd and 12th months in postoperative follow-up. Method of measurement: Disabilities of the arm, shoulder and hand (DASH) questionnaire. Comparison of the effect of surgical procedure on postoperative hand grip strength. Timepoint: 3rd and 12th months in postoperative follow-up. Method of measurement: Dynomometer. Comparison of the effect of surgical procedure on postoperative wrist range of motion (ROM). Timepoint: 3rd and 12th months in postoperative follow-up. Method of measurement: Goniometer. Vice Chancellor for research and technology, Shahid Beheshti University of Medical Sciences Approved 2019-05-31 Shahid Beheshti university of medical science Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway Tehran Tehran Iran (Islamic Republic of)