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IRCT20220304054177N1 IRCT 2022-03-09 Iran University of Medical Sciences Evaluation of the effect of digital monitoring system on surgical success Evaluation of the effect of digital monitoring system on weight-bearing of patients undergoing orthopedic lower extremities surgery on surgical success 2022-03-19 anticipated 216 Complete https://irct.ir/trial/62360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After the participants were selected to study, we will use simple randomization method to assign participants to the groups for received intervention and comparison. The randomization process will be performed using Random Allocation software, and since this study consists of two groups, the allocation outputs of the participants will be identified by A and B so the assign of each patient in each group is unpredictable to other members of the research team. We will notify for the team manager after selecting each patient and they will determine the type of group each person according to the software output, Blinding description: Double blinding was considered for this study. Due to the different process of interventions in the study groups, the patient outcome assessor and data analyzer will be blinded of the type of patient interventions. 2-3 Orthopedic postoperative care. Intervention 1: Intervention group: Patients who use a digital weight-bearing control device embedded on a cane or shoe after lower extremities orthopedic surgery. Intervention 2: Control group: Patients who use a ordinary cane or shoes after lower extremities orthopedic surgery. Yes - There is a plan to make this available What will be shared: Finding of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables. When: Availability six months after the end of study To whom: Orthopedics Conditions: Anyone who has a request for information about the results of this research Where to obtain: Iran University of Medical Sciences How to obtain: By referring to the central library and clinical trial center in Iran University of Medical Sciences can access to the documents of participants, data and results. Comments:
public Alireza Amanollahi
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6653 9260 amanollahi.a@gmail.com Shahid Beheshti University of Medical Sciences scientific Mehdi Moghtadaei
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6653 9260 mmoghtadaei@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with joint replacement surgery Patients with fracture surgery Patient willingness to participate in the study 18 years no limit Both Having an infection Unavailability of the patient for follow-up Z47.8 Other specified orthopaedic follow-up care Rehabilitation Rehabilitation Intervention group: Patients who use a digital weight-bearing control device embedded on a cane or shoe after lower extremities orthopedic surgery. Control group: Patients who use a ordinary cane or shoes after lower extremities orthopedic surgery. Callus formation. Timepoint: Three months after surgery. Method of measurement: Radiography. Postoperative infection. Timepoint: Monthly postoperative examinations for three months. Method of measurement: Physical examination. Iran University of Medical Sciences Approved 2022-02-22 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat highway Tehran Tehran Iran (Islamic Republic of)