Ultrasound Combined With SMI Imaging on Children With Limb Lengthening

NCT ID: NCT07026188

Last Updated: 2025-06-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-25

Study Completion Date

2025-01-31

Brief Summary

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In the present study, The use of ultrasound allows observation of new bone formation in the distraction gap, also visualize the formation of blood vessels in the distraction gap, including the velocity and resistance of blood vessels, and can also indicate the environment of new bone formation. It's considered that ultrasound detection of new bone and angiogenesis in the process of bone lengthening in children could be a good supplement to X-ray evaluation, and even partially replace the former, reducing the radiation burden of pediatric patients.

Detailed Description

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Limb lengthening is one of most common surgical techniques for correcting limb deformities in pediatric patients. The evaluation of new bone formation in the distraction gap is very important for the prognosis of limb lengthening. After limb lengthening, weekly or biweekly plain X-ray is the most commonly-used method to evaluate new bone formation in the distraction gap. However, Ordinary X-ray (film or digital) cannot provide details of regeneration or vascular regeneration like ultrasound examination, and radiation damage caused by X-ray or CT has unpredictable negative effects on minors. Ultrasound and X-ray examination were performed every 2 weeks during lengthening in 30 pediatric patients. Ultrasound was used to observe the formation of new bone, the number of vertical vessels and the blood flow resistance index, which were compared with the corresponding X-ray findings.New bone states could be divided by US into three stages: stage I (early lengthening): no obvious callus formation was found X-ray and ultrasound; stage II (lengthening stage): X-ray showed low density callus formation and uneven density, which was divided into three stages by ultrasound: IIa, punctate callus could be seen; IIb, linear callus was found, but not connected; IIc, connected linear callus was found; stage III (healing stage): the broken ends of the bone were joined, the periosteum was continuous, and the callus had disappeared. X-ray showed healing of the lengthened bone.

Conditions

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Bone Anomalies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone-lengthening in children

Children who undergo bone-lengthening were taken US examination timely, to evaluate the bone recovering by one US doctor.

Ultrasound with SMI

Intervention Type OTHER

The use of ultrasound allows observation of new bone formation in the distraction gap, also visualize the formation of blood vessels in the distraction gap with SMI, including the velocity and resistance of blood vessels, and can also indicate the environment of new bone formation. All US examination were performed by one US doctor.

Interventions

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Ultrasound with SMI

The use of ultrasound allows observation of new bone formation in the distraction gap, also visualize the formation of blood vessels in the distraction gap with SMI, including the velocity and resistance of blood vessels, and can also indicate the environment of new bone formation. All US examination were performed by one US doctor.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All are children who suffer limb length discrepancy and need limb-lengthening procedure; with no difference in sex, age or ethics.

Exclusion Criteria

* Space of braces is smaller than the probes.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ning Bo, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric hospital of Fudan University

Locations

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Children's Hospital of Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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ningbo1425

Identifier Type: -

Identifier Source: org_study_id

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