Ultrasound Use to Measure Magnetically Controlled Growing Rods

N/AEnrolling By InvitationNCT07212049

Nemours Children's Clinic10 enrolled

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Limb Length Discrepancy

Interventions

ultrasound measurementDEVICE

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 femurDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nemours Children's Hospital Florida

Orlando, Florida, United States

Outcomes

Primary Outcomes

Ultrasound Measurement of the lengthening rod

ultrasound measurement of the length of the internal lengthening rod

Time frame: 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.

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

Secondary Outcomes

Cost of imaging

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.

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

Pain reported during imaging

Pain experienced will measured with Wong-Baker faces pain rating scale during imaging with x-ray and ultrasound

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

Data from ClinicalTrials.gov

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