Меню
Набор по приглашению NCT07212049

Ultrasound Use to Measure Magnetically Controlled Growing Rods

Без фазы С лечением Limb Length Discrepancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ultrasound measurement, X-ray imaging of tibia and/or femur.
Кому может быть актуально
Состояния в реестре: Limb Length Discrepancy. Базовые параметры: 8 лет — 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Using Ultrasound as an Alternative to Radiography in Measuring Magnetically Controlled Growing Rods (MCGR) in Tibia and Femur Lengthening Patients

Обзор

The goal of this clinical trial is to learn if an ultrasound can measure the length of an internal tibia and femur lengthening rod. The main questions it aims to answer are: Can an ultrasound be used to measure the length of an internal magnetic lengthening nail in a tibia or femur? Can an ultrasound measure the rod lengthening as well as an ultrasound? Researchers will compare the length of an internal magnetic lengthening rod with both x-rays and ultrasound Participants will: Have standard x-rays every week They will also have an ultrasound of the femur or tibia

Подробное описание

Limb lengthening with expanding intramedullary rods has become the standard of care for limb lengthening procedures. The procedure entails performing an osteotomy of the short bone and placing a mechanical expanding intramedullary nail. The aim of the study is to explore the role of ultrasound to measure tibia and femur lengthening procedures and compare the accuracy to standard radiographs.

The study design is a prospective, pilot study of 5 tibias and 5 femurs. Measurements of the femurs and tibias will be obtained in 3 separate locations to try to identify areas that can be visualized and measured by an ultrasound. The cost of the ultrasound will be compared to the cost of x-rays, and any pain regarding imaging modalities will also be compared

Вмешательства

  • Устройство ultrasound measurement
    Three different measurements will be obtained using an ultrasound to determine the length gained from lengthening the tibia and/or femur with an internal lengthening rod. Please see the protocol on the locations that will me measured.
  • Диагностический тест X-ray imaging of tibia and/or femur
    All patients will have an x-ray with two views anterior-posterior and lateral to measuring the lengthening of the internal rod. Please see the protocol for locations of the measurements being obtained.

Первичные конечные точки

  • Ultrasound Measurement of the lengthening rod [Срок оценки: Once a week during the lengthening process, up to 10 weeks]
  • X-ray measurement of the lengthening rod [Срок оценки: Once a week during the lengthening process, up to 10 weeks]
Вторичные конечные точки (2)
  • Cost of imaging [Срок оценки: Once a week during the lengthening process, up to 10 weeks]
  • Pain reported during imaging [Срок оценки: Once a week during the lengthening process, up to 10 weeks]

Критерии участия

Критерии включения

  • Patients undergoing tibia or femur lengthening with an intramedullary mechanical rod.

Критерии исключения

  • Patients who underwent lengthening procedure with any other device such as external fixator.
  • Patients under 8 years old and over 21 years of age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Nemours Children's Hospital Florida — Orlando

Публикации

  • Stokes OM, O'Donovan EJ, Samartzis D, Bow CH, Luk KD, Cheung KM. Reducing radiation exposure in early-onset scoliosis surgery patients: novel use of ultrasonography to measure lengthening in magnetically-controlled growing rods. Spine J. 2014 Oct 1;14(10):2397-404. doi: 10.1016/j.spinee.2014.01.039. Epub 2014 Jan 31. PMID 24486476
  • Cobanoglu M, Shah SA, Gabos P, Rogers K, Yorgova P, Neiss G, Grissom L, Mackenzie WG. Comparison of Intended Lengthening of Magnetically Controlled Growing Rods: Ultrasound Versus X-Ray. J Pediatr Orthop. 2019 Feb;39(2):e141-e146. doi: 10.1097/BPO.0000000000001072. PMID 29016427
  • Yoon WW, Chang AC, Tyler P, Butt S, Raniga S, Noordeen H. The use of ultrasound in comparison to radiography in magnetically controlled growth rod lengthening measurement: a prospective study. Eur Spine J. 2015 Jul;24(7):1422-6. doi: 10.1007/s00586-014-3589-z. Epub 2014 Sep 26. PMID 25256680
  • Cheung JP, Bow C, Samartzis D, Ganal-Antonio AK, Cheung KM. Clinical utility of ultrasound to prospectively monitor distraction of magnetically controlled growing rods. Spine J. 2016 Feb;16(2):204-9. doi: 10.1016/j.spinee.2015.10.044. Epub 2015 Oct 30. PMID 26523963
  • Schiedel FM, Buller TC, Rodl R. Estimation of patient dose and associated radiogenic risks from limb lengthening. Clin Orthop Relat Res. 2009 Apr;467(4):1023-7. doi: 10.1007/s11999-008-0624-6. Epub 2008 Nov 22. PMID 19030942
  • Laubscher M, Mitchell C, Timms A, Goodier D, Calder P. Outcomes following femoral lengthening: An initial comparison of the Precice intramedullary lengthening nail and the LRS external fixator monorail system. Bone Joint J. 2016 Oct;98-B(10):1382-1388. doi: 10.1302/0301-620X.98B10.36643. PMID 27694593

Идентификаторы

NCT: NCT07212049 · 2169786

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗