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IRCT20190903044677N1 IRCT 2019-11-09 Iran University of Medical Sciences Treatment of the Distal Radius Fracture with Closed Reduction and Percutaneous Pinning without ‎Superficial Radial Nerve Exploration Comparison of the Treatment of the Distal Radius Fracture with Closed Reduction and Percutaneous Pinning with and without ‎Superficial Radial Nerve Exploration 2019-11-22 anticipated 100 Complete https://irct.ir/trial/41893 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using a computer-generated random number list. For this purpose, the ‎patients will be numbered from 1 to 100. Within this range, 50 random numbers will be generated by ‎Excel software. These random numbers will be matched with the patients' numbers, and ‎corresponding patients will be allocated into the case group. The remaining 50 patients will be ‎allocated to the control group. Accordingly, participants will randomly be assigned in a 1:1 ‎ratio into the two study groups, Blinding description: The patients will be blinded from the group assignment. N/A Distal radius fracture. Intervention 1: Intervention group: Treatment of distal radius fracture with closed reduction and percutaneous pinning without ‎superficial radial nerve exploration. Intervention 2: Control group: Treatment of distal radius fracture with closed reduction and percutaneous pinning with ‎superficial radial nerve exploration. Yes - There is a plan to make this available What will be shared: All the data associated with this study are sharable upon request, after anonymizing the participants. When: 6 months after the publication of the results To whom: Academic investigators Conditions: The applicant should provide sufficient documents to prove his/her academic identity. Allowed use of the data is dependent on the confirmation of the performers of this study. Where to obtain: Dr. Pouria Tabrizian, Shafa Orthopedic Hospital, Mojahedine-eslam Ave., Tehran. Tel: 00982133542041 Email: tabrizian.pouria@gmail.com How to obtain: Email application for the data request, Evaluation of the request, identification of the applicant, the reason for requesting data, evaluation of the provided reasons, sending data through email in case of confirming the provided reasons. Comments:
public Pouria Tabrizian
Mojaheine-eslam Ave.
Tehran Iran (Islamic Republic of) 1157637131 +98 21 3354 2041 tabrizian.p@iums.ac.ir Shafa Orthopedic Hospital scientific Pouria Tabrizian
Mojahedine-eslam Ave.
Tehran Iran (Islamic Republic of) 1157637131 +98 21 3354 2041 tabrizian.p@iums.ac.ir Shafa Orthopedic Hospital Iran (Islamic Republic of) Age of more than 18 years Providing written consent to participate in the study 18 years no limit Both A history of distal radius fracture Concomitant injury affecting the outcome of treatment M84.333A Stress fracture, right radius, initial encounter for fracture Treatment - Surgery Treatment - Surgery Intervention group: Treatment of distal radius fracture with closed reduction and percutaneous pinning without ‎superficial radial nerve exploration Control group: Treatment of distal radius fracture with closed reduction and percutaneous pinning with ‎superficial radial nerve exploration First dorsal web sensation. Timepoint: Before the intervention and two days after the end of intervention. Method of measurement: Patients' clinical examination. Paresthesia‎. Timepoint: Before the intervention and two days after the end of intervention. Method of measurement: Patients' clinical examination. Hyperesthesia‎. Timepoint: Before the intervention and two days after the end of intervention. Method of measurement: Patients' clinical examination. Wrist range of motion. Timepoint: Before the intervention and 12 months after the end of intervention. Method of measurement: Goniometer. Wrist function. Timepoint: Before the intervention and 12 months after the end of intervention. Method of measurement: DASH questionaire. Pinch strength. Timepoint: Before the intervention and 12 months after the end of intervention. Method of measurement: Dinamometer. Pain. Timepoint: Before the intervention and 12 months after the end of intervention. Method of measurement: Visual analogue scale. Iran University of Medical Sciences Approved 2019-07-01 Ethics committee of Iran University of Medical Sciences Next to the Milad tower, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)