Ultrasound Use to Measure Magnetically Controlled Growing Rods

October 31, 2025 updated by: Jason Malone, Nemours Children's Clinic

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • Nemours Children's Hospital Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound of lengthening rod
All patients will have an ultrasound measuring the lengthen of the internal rod
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.
Other Names:
  • Radiographs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound Measurement of the lengthening rod
Time Frame: Once a week during the lengthening process, up to 10 weeks
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
Time Frame: Once a week during the lengthening process, up to 10 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of imaging
Time Frame: Once a week during the lengthening process, up to 10 weeks
The cost of ultrasound and x-rays. The ultrasound has no cost as it is a point-of-care device. The x-ray cost will derived from the mast charge that is post online for Nemours Children's Hospital Florida. The cash charge for a tibia two view x-ray is $471. The cash charge for a femur two view x-ray is $282.
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
Pain experienced will measured with Wong-Baker faces pain rating scale during imaging with x-ray and ultrasound
Once a week during the lengthening process, up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Estimated)

September 5, 2026

Study Completion (Estimated)

September 5, 2026

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Estimated)

October 8, 2025

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2169786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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