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临床试验/NCT06516497
NCT06516497已完成不适用

Use of Motion Sensors in Correction Procedures of Long Bone Deformities in the Pediatric Age Group

Ataturk University2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2024年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
measuring preoperative deformity angles

研究概览

简要总结

Motion sensors will be used in long bone deformity surgery in pediatric patients.

In patients whose deformity status is determined before the surgery, 2 wires will be placed in the same plane from the proximal and distal of the determined osteotomy line to the long bones of the patients who are anesthetized during the surgery and motion sensors will be placed on the wires. Osteotomy will be performed on the bone with deformity from the deformity center. While correcting the degree of deformity, fixation with plate and screws will be performed after the amount of correction determined preoperatively is achieved. Thanks to the sensors and application, it will be determined exactly how many degrees of deformity will be corrected in the case. At the same time, multiplanar and difficult-to-detect deformities will be corrected almost ideally with the help of motion and acceleration sensors. Approximately at the 6th week after the case, deformity correction status will be recorded again with gait analysis and physical examination following the removal of the cast, splint and bone healing. The results will be compared after the traditional method and the method using sensors are performed with an equal number of patients. As a result, it is aimed to clearly correct the deformity quantitatively and shorten the surgical time.

详细描述

Patients who are between the ages of 2 and 18, who are admitted to Atatürk University Faculty of Medicine Research Hospital, who are considered to have long bone deformities in their lower extremities and who have gait disorders and who have not previously undergone lower extremity surgery, will be included in the study. To determine the degree of preoperative deformity of these patients, a physical examination will be performed after gait analysis and foot advancement angles, hip rotation degrees, thigh foot angles, transmalleolar axis angles and forefoot alignment will be determined and recorded. Following the routine preoperative computerized tomography performed on the patients, long bone alignment disorders, joint incompatibilities (valgus, varus deformities), femoral anteversion, femoral retroversion, tibial torsion angles will be determined quantitatively, and the amount of deformity correction to be performed in the surgery will be determined before the surgery and the quantitative values will be recorded. After two wires are placed in the same plane from the proximal and distal parts of the determined osteotomy line, motion sensors will be placed on the long bones of the anesthetized patients during the surgery. Osteotomy will be performed on the bone with deformity from the deformity center. When correcting the degree of deformity, fixation with plate and screws will be performed after the correction is achieved by the amount of deformity determined preoperatively. (In other countries and in our country, approximate correction is provided without quantitative data. Although the preoperative degree of deformity can be determined quantitatively, surgery is performed by determining the degree of correction intraoperatively by eye decision.) Thanks to the sensors and application, exactly how many degrees of deformity will be corrected will be determined in the case. At the same time, multiplanar and difficult-to-detect deformities will be corrected almost ideally with the help of motion and acceleration sensors. Approximately at the 6th week after the case, deformity correction status will be recorded again with gait analysis and physical examination following the removal of the cast, splint and bone healing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of long bone deformity
  • Must be between the ages of 2 and 18 when applying for deformity correction.

排除标准

  • Patients or their parents do not accept surgical treatment
  • Not being between the ages of 2 and 18

结局指标

主要结局

measuring preoperative deformity angles

时间窗: 2 months

A preoperative clinical examination will be performed in pediatric orthopedic deformity patients, especially in patients who lean in, lean out, or cannot fully extend their knees. During the clinical examination, measurements will be made with a goniometer or on a computer by taking photographs. For rotational deformities in the transverse plane, the foot advancement angle, femoral internal and external rotation angles, and transmalleolar axis angle will be measured and noted. In patients with extension limitation, the degree of limitation will be measured by goniometer or conventional radiographs. The amount of deformity will be determined exactly and the surgery will be performed.

measuring postoperative deformity angles

时间窗: 2 months

The amount of deformity corrected after surgery will be measured and noted by clinical examination and conventional x-rays 2 months later, after the child has recovered.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Cagatay Engin

ASSOCIATE PROFESSOR

Ataturk University

研究点 (2)

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