Bone AnomaliesNCT07026188
Ultrasound Combined With SMI Imaging on Children With Limb Lengthening
An observational study of Bone Anomalies, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bone Anomalies
- What is being tested?
- Ultrasound with SMI
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2021to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: All are children who suffer limb length discrepancy and need limb-lengthening procedure; with no difference in sex, age or ethics.
Who may be able to join
- All are children who suffer limb length discrepancy and need limb-lengthening procedure; with no difference in sex, age or ethics.
Who cannot join
- Space of braces is smaller than the probes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of New Bone Formation During Limb Lengthening in Children by Ultrasound Combined With Superb Microvascular Imaging
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.
Read the detailed description
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
- Bone Anomalies
- Being tested
- Ultrasound with SMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound with SMIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone-lengthening in children | Children who undergo bone-lengthening were taken US examination timely, to evaluate the bone recovering by one US doctor. Receives: Other: Ultrasound with SMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gray scale of US in bone gap.
New bone states were divided 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.
Measured: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
New vessels of bone gap.
The number of vessels in the lengthening gap, assessed via ultrasound techniques like SMI, reflects the vertical vessels growing into the distraction gap. This metric offers insights into the microvascular environment and angiogenesis of the new bone, aiding in evaluating healing progress and guiding lengthening protocol adjustments.
Measured: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
Resistance index of new vessles.
The resistance index of new vessels, measured using ultrasound techniques like SMI, assesses blood flow resistance in the newly formed vessels within the lengthening gap.
Measured: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
Healing index
The healing index, calculated as healing time in months divided by lengthening distance in centimeters, serves as an objective indicator of limb lengthening prognosis. A smaller healing index signifies a faster healing rate.
Measured: From the first day of lengthening to 2 months after the removal of the external fixator.（Approximately 8 months.）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start25 Dec 2021
- Primary completion1 Jun 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AnomaliesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Bo, MD, Principal investigator, Pediatric hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026188
- Sponsor's protocol ID
- ningbo1425
- Status last verified
- Jun 2025
- First submitted
- 19 Feb 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of New Bone Formation During Limb Lengthening in Children by Ultrasound Combined With Superb Microvascular Imaging
- ClinicalTrials.gov ID
- NCT07026188
- Acronym / sponsor ID
- ningbo1425
- Conditions
- Bone Anomalies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone-lengthening in children | – | Other: Ultrasound with SMIChildren who undergo bone-lengthening were taken US examination timely, to evaluate the bone recovering by one US doctor. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All are children who suffer limb length discrepancy and need limb-lengthening procedure; with no difference in sex, age or ethics.
Key inclusion criteria (1 listed)
- All are children who suffer limb length discrepancy and need limb-lengthening procedure; with no difference in sex, age or ethics.
Key exclusion criteria (1 listed)
- Space of braces is smaller than the probes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound with SMIThe 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. | Other | Bone-lengthening in children |
Primary outcome
Gray scale of US in bone gap.
Time frame: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
New bone states were divided 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.
New vessels of bone gap.
Time frame: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
The number of vessels in the lengthening gap, assessed via ultrasound techniques like SMI, reflects the vertical vessels growing into the distraction gap. This metric offers insights into the microvascular environment and angiogenesis of the new bone, aiding in evaluating healing progress and guiding lengthening protocol adjustments.
Resistance index of new vessles.
Time frame: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）
The resistance index of new vessels, measured using ultrasound techniques like SMI, assesses blood flow resistance in the newly formed vessels within the lengthening gap.
Healing index
Time frame: From the first day of lengthening to 2 months after the removal of the external fixator.（Approximately 8 months.）
The healing index, calculated as healing time in months divided by lengthening distance in centimeters, serves as an objective indicator of limb lengthening prognosis. A smaller healing index signifies a faster healing rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Bo, MD principal investigator
Pediatric hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Anomalies, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gray scale of US in bone gap. (time frame: From the first day of lengthening to the removal of the external fixator.（Approximately 6 months.）). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.