]>
IRCT20201206049615N1 IRCT 2021-02-21 Tabriz University of Medical Sciences effect of ponseti method in treatment of clubfoot Comparison of the range of motion and clinical score of two legs in patients with clubfoot treated with Ponseti and modified ponseti method 2021-03-21 anticipated 100 Complete https://irct.ir/trial/53854 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: only the surgeon knows about the study groups the surgeon assigns a code to each patient and divides the patients into two groups called 1 and 2 (that are treated with ponseti or modified ponseti method) after obtaining informed consent from patients, they do not know anything about study groups and therapeutic methods. the researcher who evaluates the therapeutic results ( range of motion of ankle in all directions and Dimeglio and Pirani scores) and the analyzer who analyzes the research results do not know anything about the patient groups and just work with patient codes and group codes. N/A clubfoot. Intervention 1: Control group: This group of patients who suffer from clubfoot are first manipulated and plastered by a surgeon at two-week intervals, and after partial correction, they undergo Achilles tenotomy, after which they are plastered for three weeks. This treatment is called ponseti method, which is currently the most common treatment for clubfoot. Intervention 2: Intervention group: This group of patients who suffer from clubfoot are first manipulated and plastered by the treating surgeon at two-week intervals, and after partial correction, they undergo Achilles tenotomy, after which the cast is performed for three weeks. (As was done in the control group) but after three weeks the plaster is opened and unlike the control group, the manipulation is done again and the plaster is done again for three weeks. Yes - There is a plan to make this available What will be shared: All information about patients after their non-identification, study protocol, informed consent forms, data analysis processes, and codes used in them after the study in the form of a research project entitled "Comparison of range of motion and performance score of two The foot in patients with clubfoot treated with ponseti and modified ponseti method "will be available through the Vice Chancellor for Research of Tabriz University of Medical Sciences and also through the publication of an article with the same title in international journals. When: The access period starts from March 2023 To whom: After uploading the data to the research vice-chancellor of Tabriz University of Medical Sciences, any person can access the data in coordination with the relevant unit. Also, after the publication of the article in international articles, all researchers and individuals can access the article according to the rules of the relevant journal. Conditions: Access to the data will be possible after the coordination and approval of the Vice-Chancellor for Research of Tabriz University of Medical Sciences, and any use of data and study information is allowed after citation to the relevant references and citation to the names of the main researchers of the study. Where to obtain: Applicants can send their application to the Vice-Chancellor for Research of Tabriz University of Medical Sciences at the following address to access the study information: International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, PO Box: 5165665931, Iran tel:0098 41 33363767 How to obtain: The request for access to the data, after being submitted by the applicants, will be reviewed by the Vice-Chancellor for Research of Tabriz University of Medical Sciences, and if the applicants agree to the above-mentioned conditions, it will be available to them. Comments:
public Hoseyn Aslani
Tabriz Shohada hospital, Golshahr Ave, Tabriz
Tabriz Iran (Islamic Republic of) 5166617692 +98 41 3389 3336 Shohadacrdu@gmail.com Tabriz University of Medical Sciences scientific Hoseyn Aslani
Tabriz Shohada hospital, Golshahr Ave, Tabriz
Tabriz Iran (Islamic Republic of) 5166617692 +98 41 3389 3336 Shohadacrdu@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) all of the children suffering from bilateral clubfoot 3 months 2 years Both age under 3 months age over 2 years history of other deformities in the lower extremities history of neuromuscular diseases history of clubfoot treatment with other methods M21.54 Acquired clubfoot Treatment - Surgery Treatment - Surgery Control group: This group of patients who suffer from clubfoot are first manipulated and plastered by a surgeon at two-week intervals, and after partial correction, they undergo Achilles tenotomy, after which they are plastered for three weeks. This treatment is called ponseti method, which is currently the most common treatment for clubfoot. Intervention group: This group of patients who suffer from clubfoot are first manipulated and plastered by the treating surgeon at two-week intervals, and after partial correction, they undergo Achilles tenotomy, after which the cast is performed for three weeks. (As was done in the control group) but after three weeks the plaster is opened and unlike the control group, the manipulation is done again and the plaster is done again for three weeks. Range of motion of ankle. Timepoint: The range of motion of the ankle is measured before the intervention, immediately after the intervention, one month after the intervention, and then at intervals of 3 months to 6 months. Method of measurement: The range of motion of the ankle in all sections is measured by one person so that the range of motion including Dorsiflexion, plantar flexion, eversion, inversion is measured by goniometer per unit of degree. Ankle functional score. Timepoint: The ankle functional score is measured before the intervention, immediately after the intervention, one month after the intervention, and then at intervals of 3 months to 6 months. Method of measurement: This score is measured by the global systems of Dimeglio and Pirani introduced by scientists of the same name. Each of these systems gives a score based on the appearance of the patient's foot, the condition of the skin folds, the degree of deformity, the range of motion of the ankle in different directions, and the consistency of the deformity, which is compared before and after the intervention. Tabriz University of Medical Sciences Approved 2020-09-14 Ethics committee of Tabriz University of Medical Sciences International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)