Ultrasound Use to Measure Magnetically Controlled Growing Rods

NCT07212049 | Enrolling By Invitation FDA Device

• 1 other identifier: 2169786
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Limb Length Discrepancy

Keywords

limb lengthening; leg length difference

Outcome Measures

Primary Outcomes (2)

• Ultrasound Measurement of the lengthening rod

  ultrasound measurement of the length of the internal lengthening rod

  Once a week during the lengthening process, up to 10 weeks

• X-ray measurement of the lengthening rod

  X-ray measurement of the internal lengthening rod at three points on the rod.

  Once a week during the lengthening process, up to 10 weeks

Secondary Outcomes (2)

• Cost of imaging

  Once a week during the lengthening process, up to 10 weeks

• Pain reported during imaging

  Once a week during the lengthening process, up to 10 weeks

Study Arms (1)

Ultrasound of lengthening rod

EXPERIMENTAL

All patients will have an ultrasound measuring the lengthen of the internal rod

Device: ultrasound measurement; Diagnostic Test: X-ray imaging of tibia and/or femur

Interventions

ultrasound measurement DEVICE

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.

Ultrasound of lengthening rod

X-ray imaging of tibia and/or femur DIAGNOSTIC_TEST

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.

Also known as: Radiographs

Ultrasound of lengthening rod

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Hospital Florida

Orlando, Florida, 32827, United States

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Orthopedic Surgeon

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 21, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)