Comparison of two Cheneanu brace made by two methods: "using a frame and 3D scanning" and "conventional" method on cobb angle correction, apical vertebral rotation, kyphosis and lordosis in adolescent girls with idiopathic scoliosis: a randomized clinical trial

Determining the effectiveness of two Cheneaue orthoses made by the method of "use of a targeted frame and three-dimensional scanning" and the "usual" method in correcting Cobb angle, vertebra rotation, kyphosis and lordosis in adolescent girls with idiopathic scoliosis.

The samples are randomly selected by block method.

CAD/CAM equipment is installed in the orthosis department of Farbod Technical Orthopedic Center and design and manufacturing work is done.

Adolescent idiopathic scoliosis patients are selected through accessible sampling. According to the entry and exit criteria, people from hospitals affiliated to Isfahan University of Medical Sciences are referred to the technical orthopedic clinic by a spine specialist. People who meet the entry criteria are included in the study after the approval of a specialist doctor. In order to simulate the two control and experimental groups, the coronal deformity angular ratio (C-DAR) is used, which is a measure to predict the long-term results of orthotic treatment. All people with double or single curvature with coronal deformity angular ratio below 6 can enter the study. People who do not use braces in any of the considered short-term and long-term courses and do not participate in the evaluations on time will be excluded from the study.

In the intervention group, using a purposeful rotating frame, the primary forces of the brace are simulated and a 3D scan is taken from the patient's torso, without removing the problems of traditional methods. In the control group, a plaster mold is taken from the patient according to the principles of conventional molding, and both the digital mold and the plaster mold go to the mold modification stage.

Cobb's angle, Apical vertebra rotation

In order to control the confounding variables, the samples are randomly divided into two equal groups using the block method, including the test (users of the new Cheneau brace) and the control (users of the usual Cheneau brace). The way of random assignment in both groups is that the size of each block is considered to be 4 people, and based on this and considering the two experimental groups that have new braces (N) and the control group that have regular braces (O). , the number of 6 blocks is obtained. The arrangement of the members of each block will be (NNOO), (NOON), (NONO), (OONN), (ONNO) and (ONON). Then, these 6 states are written separately on paper and poured into a container, and with 8 rounds of lottery, the number of 15 sample people for each group and 30 people in total are selected.

In order to control biases, evaluation of values is done by two people, independently and separately. The evaluators include two experienced orthotists, apart from the researcher, who use the Digimizer software (Digimizer, MedCalc Software, V.5.7.5, Belgium) to draw and measure the case. They perform the need on the digital image of each patient. In fact, each evaluator does his work without knowing which treatment group each patient is assigned to. This software is used for anthropometric measurements. The radiographic image of each patient at each stage is analyzed three times by each evaluator and with a minimum interval of one week between repeated measurements, by both evaluators and randomly. Each evaluator will be unaware of the measurements made by another person as well as his previous evaluation of the same graph, and finally the average measurement of each evaluator will be recorded for each person. It should be noted that in order to match the measurement method of both evaluators as much as possible, before starting the evaluations, the reproducibility between the two evaluators is checked. In this way, ten numbers of radiographic images are given to each evaluator in a similar way, and if there is no significant difference between the numbers reported by the two evaluators, they start the measurements related to the study.

Part of the data, such as the type and degree of deformity of the participants

The access period starts 6 months after the results are published

Only researchers working in university and scientific institutions

Only judges

To the project manager or researcher

It will be available to them without any problem

No problem