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IRCT20211107052989N1 IRCT 2021-11-25 Gonabad University of Medical Sciences Comparison between Surgical Treatments of Distal Radius Fracture and Investigation of their Skin Complications Comparison between “External Fixation” and “Percutaneous Pinning” in the Treatment of Distal Radius Fractures and Investigation of their Skin Complications: A Randomized Clinical Trial 2021-11-22 anticipated 64 Complete https://irct.ir/trial/59877 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use "Block randomization" in this study. The size of all blocks will be equal; As a result, in this two-group study, there will be quadruple blocks (including two cases from the External Fixation group and two cases from the Percutaneous Pinning group) and there will be six acceptable sequences: AABB, ABAB, ABBA, BAAB, BABA, BBAA. In the next step, we randomly will choose from the acceptable sequences, so that we can have our required sample size (for example, to have 64 cases, we will need 16 quadruple sequences). Each random sequence will be recorded on a card and the cards will be enveloped and placed inside a box. For each participant, one of the envelopes will be opened and the assigned group of that participant will be revealed. N/A Distal Radius Fracture (DRF). Intervention 1: Intervention group: Percutaneous pinning: we will use two or three wires to fix the fracture. One in the styloid process of radius and the other in the ulnar side of radius. Intervention 2: Intervention group: External fixation: in this method we will put two schanz pins in 2nd metacarpal bone and two in radius; Then we will bridge the radiocarpal joint using external fixator. Yes - There is a plan to make this available What will be shared: 1. Deidentified Individual Participant Data Set (IPD): Once unidentificaton, all potential data will be available. 2. Study Protocol: Will be completely available. 3. Statistical Analysis Plan: Includes the way in which the data will be statistically evaluated. 4. Informed Consent Form: The unfilled form of informed consent will be available. The form of each patient will not be available due to ethics. 5. Clinical Study Report: Will be completely available. When: Starting 6 months after publication To whom: It is only available for people working in academic institutions or people working in related businesses (e.g., biomedical engineering). Conditions: Access to data will be available for mentioned groups and individuals, if the request contains: "what are required, the reason of requirement, and the type of analysis to be performed on the data". Reasons of requirement include: writing meta-analyzes or review articles, evaluating confounders and conducting complementary projects, and using data for engineering sciences research projects. Where to obtain: People can contact any of the following to request. The request should include "what are required, the reason of requirement, and the type of analysis to be performed on the data". Mehran Khazaei Phone No.: 00989105620084 E-mail: Mehran_Khazaei@yahoo.com How to obtain: A. Sending request by applicant B. Receiving the request and reviewing by .... of the project C. Documenting the requested data in the appropriate format D. Sending data to the applicant * The total time required for this process will be 3-6 working days, depending on the volume of requested information and their format. ** This time may last longer for "Statistical Analysis Plan" (up to two weeks) Comments:
public Mehran Khazaei
No. 6, 5th Naser-Khosro Ave.
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3967 Khazaei.m.stu@gmu.ac.ir Gonabad University of Medical Sciences scientific Meisam Moradi
Parastar Blvd., Sa'adi Ave., Bohlool hospital
Gonabad Iran (Islamic Republic of) 9691797852 +98 51 5723 6833 moradimeisam@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Closed Distal Radius Fracture Extra-articular Distal Radius Fracture 18 years 65 years Both Unstable Distal Radius Fracture Multiple Fractures Previous Distal Radius Fracture Peripheral Neuropathy Rheumatoid Arthritis Metabolic bone diseases (e.g. Osteomalacia, Osteoporosis) Diabetes S52.5 Fracture of lower end of radius Treatment - Surgery Treatment - Surgery Intervention group: Percutaneous pinning: we will use two or three wires to fix the fracture. One in the styloid process of radius and the other in the ulnar side of radius. Intervention group: External fixation: in this method we will put two schanz pins in 2nd metacarpal bone and two in radius; Then we will bridge the radiocarpal joint using external fixator. Wrist range of motion. Timepoint: 6 weeks, 3 months, 6 months after surgery. Method of measurement: goniometer. Damage or rupture of extensor pollicis longus tendon. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: physical examination. Radial or median nerve neuropathy. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: physical examination. Pin site infection. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: DAHL classification of pin site infection. Complex regional pain syndrome. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: physical examination. Irritant or allergic contact dermatitis in the presence of pins and casts. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: physical examination. Hypertrichosis. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: physical examination. Quantitive assessment of response to treatment and patient function. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: Mayo score. Severity of disability. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: The Disabilities of the Arm, Shoulder and Hand (DASH) Score. Volar tilt. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: wrist anteroposterior (AP) and lateral view x-ray. Ulnar (Hulten) variance. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: wrist anteroposterior (AP) and lateral view x-ray. Radial shortening. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: wrist anteroposterior (AP) and lateral view x-ray. Radial deviation. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months after surgery. Method of measurement: wrist anteroposterior (AP) and lateral view x-ray. Gonabad University of Medical Sciences Approved 2021-10-12 Ethics committee of Gonabad University of Medical Sciences Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Khorasan-Razavi, Iran Gonabad Razavi Khorasan Iran (Islamic Republic of)