Comparison between “External Fixation” and “Percutaneous Pinning” in the Treatment of Distal Radius Fractures and Investigation of their Skin Complications: A Randomized Clinical Trial

Comparison between "percutaneous pinning" and "external fixation" in distal radius fractures (DRF) and investigation of their skin complications, in the intervals of 2 weeks, 6 weeks, 3 months and 6 months after surgery.

Randomized clinical trial, two parallel groups of 64 patients, without blinding, using blocked randomization

Surgeries will done by orthopedic surgeons in Bohlool hospital (Gonabad, Razavi-Khorasan, Iran). Methods of surgeries noted in "Intervention" section.

Patients with closed and extra-articular DRF between 18 and 65 years old

1. Percutaneous pinning group: 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. 2. External fixation group: 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.

The following variables will be evaluated in each group: Wrist range of motion; Damage or rupture of the extensor pollicis longus tendon; Neuropathy; Pin site infection; Complex regional pain syndrome (CRPS); Contact dermatitis (irritant or allergic) in the presence of pins and casts; Hypertrichosis; Quantitive assessment of response to treatment and patient function (using Mayo score); Degree of wrist disability (using DASH score); and Radiological variables such as, volar angle, ulnar variance, radial shortening and radial deviation

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.

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.

Starting 6 months after publication

It is only available for people working in academic institutions or people working in related businesses (e.g., biomedical engineering).

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.

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

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)