Ultrasound Use to Measure Magnetically Controlled Growing Rods
NCT ID: NCT07212049
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
10 participants
INTERVENTIONAL
2025-09-05
2026-09-05
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ultrasound of lengthening rod
All patients will have an ultrasound measuring the lengthen of the internal rod
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients under 8 years old and over 21 years of age
8 Years
21 Years
ALL
Yes
Sponsors
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Nemours Children's Clinic
OTHER
Responsible Party
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Jason Malone
Pediatric Orthopedic Surgeon
Locations
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Nemours Children's Hospital Florida
Orlando, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: 7-11 year old Consent Guardian Assent
Document Type: Informed Consent Form: 12 to 17 year old assent
Document Type: Informed Consent Form: 7-11 year old Consent Guardian
Document Type: Informed Consent Form: consent for adult
Document Type: Informed Consent Form: 12 to 17 year old Guardian concent
Other Identifiers
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2169786
Identifier Type: -
Identifier Source: org_study_id
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