Ultrasound for Limb Length Discrepancy

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: External fixator, Age under 8, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ultrasound can effectively measure the length of a special rod used in procedures to lengthen the tibia or femur (leg bones). It aims to determine if ultrasound can match the measurement accuracy of x-rays, the standard method. Participants will undergo both x-rays and ultrasounds to compare results. The trial seeks individuals using an internal rod for leg lengthening procedures. As an unphased study, it offers participants the chance to contribute to advancing medical techniques that could reduce radiation exposure in future procedures.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for guidance.

What prior data suggests that this ultrasound technique is safe for measuring limb lengthening rods?

Research has shown that using ultrasound to measure the length of internal rods in the leg bones (tibia and femur) is generally safe. Studies have found that ultrasound can track changes in these rods without harming patients. Reports of serious side effects from using ultrasound in these situations are absent. In one study, patients were checked after using ultrasound, and no problems were found even after several weeks. This suggests that ultrasound is well-tolerated and does not cause issues for patients undergoing limb lengthening. Overall, ultrasound appears to be a safe choice for this type of measurement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasound for limb length discrepancy because it offers a non-invasive method to precisely measure the lengthening of internal rods used in treatment. Unlike traditional X-rays, which expose patients to radiation, ultrasound provides a safer way to monitor progress without harmful side effects. This approach also allows for real-time imaging, potentially leading to more accurate adjustments and better outcomes for patients undergoing limb lengthening procedures.

What evidence suggests that ultrasound is effective for measuring limb length discrepancy?

Research has shown that ultrasound can effectively measure the length of internal rods in limb lengthening procedures. In this trial, participants will undergo an ultrasound to measure the internal rod's length. Studies have highlighted the potential of combining ultrasound with artificial intelligence (AI) to accurately measure leg length differences. One study found that ultrasound, which uses sound waves to create body images, reliably tracks the length of magnetically controlled growing rods. This method has demonstrated significant benefits in measuring changes in rod length. Overall, ultrasound offers a promising non-invasive alternative to traditional x-rays for monitoring these internal rods. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with limb length discrepancy who have an internal magnetic rod in their tibia or femur. Participants will be required to undergo weekly x-rays and ultrasounds. Specific inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.

Inclusion Criteria

I am having my leg bones lengthened using a rod inside the bone.

Exclusion Criteria

Patients who underwent lengthening procedure with any other device such as external fixator

I am older than 21 and younger than 8 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo weekly x-ray and ultrasound measurements of the internal lengthening rod in the tibia or femur

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound

Trial Overview The study is testing whether ultrasound can accurately measure the length of magnetically controlled growing rods inside the leg bones as well as x-ray imaging does. It involves comparing measurements from both methods each week to see if they match up.

How Is the Trial Designed?

Group I: Ultrasound of lengthening rod Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11551063/

Diagnostic performance of deep learning for leg length ... This review highlights the potential of deep learning (DL) algorithms for accurate and reliable measurement of lower limb length and leg length discrepancy ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301562924002692

Automated Method for Growing Rod Length Measurement ... Conclusion. Using ultrasonography to monitor the rod length of MCGR has a significant benefit. Adding an AI system to an MCGR rod length adjustment clinic can ...

3. researchgate.net researchgate.net/figure/Reliability-of-leg-length-discrepancy-measurements-measured-using-ultrasound-n-14-20_tbl1_51805015

Reliability of leg-length discrepancy measurements, ... One such example is the utilization of an ultrasound probe affixed to a rod, accompanied by a laser system to measure the distance from the ground to the rod.

4. ctv.veeva.com ctv.veeva.com/study/ultrasound-use-to-measure-magnetically-controlled-growing-rods

Ultrasound Use to Measure Magnetically Controlled Growing ... The goal of this clinical trial is to learn if an ultrasound can measure the length of an internal tibia and femur lengthening rod.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34780384/

What Are the Potential Benefits and Risks of Using ... Ninety-seven percent (87 of 90) of patients completed lengthening with the implant remaining in situ until the end of distraction. The median ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8687568/

Leg length discrepancy: A systematic review on the validity ... The objective of this systematic review was to identify and describe the validity and reliability of different assessments and imaging diagnostics for the ...

7. researchgate.net researchgate.net/publication/357200599_Leg_length_discrepancy_A_systematic_review_on_the_validity_and_reliability_of_clinical_assessments_and_imaging_diagnostics_used_in_clinical_practice

(PDF) Leg length discrepancy: A systematic review on the ... The objective of this systematic review was to identify and describe the validity and reliability of different assessments and imaging diagnostics for the ...

8. elsevier.es elsevier.es/es-revista-revista-espanola-cirugia-ortopedica-traumatologia-429-articulo-ultrasound-control-magnet-growing-rod-S198888561630030X

Ultrasound control of magnet growing rod distraction in ... The patient was examined after 3 weeks and no anomalies were detected. In the third month after the initial operation the first elongation of the rods took ...

9. trial.medpath.com trial.medpath.com/clinical-trial/5716fa16e0019c23/nct07212049-ultrasound-radiography-mcgr-tibia-femur-lengthening

Ultrasound Use to Measure Magnetically Controlled Growing ... The goal of this clinical trial is to learn if an ultrasound can measure the length of an internal tibia and femur lengthening rod.