Ultrasound Use to Measure Magnetically Controlled Growing Rods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ultrasound measurement, X-ray imaging of tibia and/or femur.
- Who it may be relevant to
- Registry conditions: Limb Length Discrepancy. Basic parameters: 8 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Using Ultrasound as an Alternative to Radiography in Measuring Magnetically Controlled Growing Rods (MCGR) in Tibia and Femur Lengthening Patients
Overview
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
Detailed description
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
Interventions
- Device 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. - Diagnostic test 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.
Primary outcome measures
- Ultrasound Measurement of the lengthening rod [Time frame: Once a week during the lengthening process, up to 10 weeks]
- X-ray measurement of the lengthening rod [Time frame: Once a week during the lengthening process, up to 10 weeks]
Secondary outcome measures (2)
- Cost of imaging [Time frame: Once a week during the lengthening process, up to 10 weeks]
- Pain reported during imaging [Time frame: Once a week during the lengthening process, up to 10 weeks]
Eligibility criteria
Inclusion criteria
- Patients undergoing tibia or femur lengthening with an intramedullary mechanical rod.
Exclusion criteria
- Patients who underwent lengthening procedure with any other device such as external fixator.
- Patients under 8 years old and over 21 years of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Nemours Children's Hospital Florida — Orlando
Publications
- 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
Identifiers
NCT: NCT07212049 · 2169786