Ultrasound Assessment of Achilles Tendon-Neurovascular Distance in Infants With Unilateral Clubfoot

March 11, 2026 updated by: Mahmoud samir, Assiut University

Measurement of Achilles Tendon-neurovascular Distance Bilaterally in Infants With Unilateral Clubfoot Deformity

This study aims to assess the distance between the Achilles tendon and nearby neurovascular bundles bilaterally in infants with unilateral clubfoot deformity using ultrasound (US)- Doppler at 1 cm and 2 cm above the calcaneal tuberosity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Idiopathic clubfoot is a congenital deformity affecting the musculoskeletal structure of the foot .The Ponseti method remains the gold standard for its correction, culminating with a percutaneous Achilles tenotomy (1). Treatment of clubfoot with the Ponseti method has improved anatomical and functional results and reduced the number of surgical interventions required (4,7). In 80-90% of cases, a percutaneous tenotomy of the Achilles tendon is needed at 3-4 months of age, if the equinus position of the foot persists after corrective casts, and if the dorsiflexion of the ankle is less than 10º (7). The surgery is often performed as an outpatient procedure under local anesthesia and seems to be low risk. However, a complication rate of up to 4 % has been recorded , and the complications include pseudoaneurysm, necrosis, or gangrene of the foot that underwent intervention (7). The safety of this procedure critically depends on the spatial relationship between the Achilles tendon and adjacent neurovascular structures (6). Our objective is to study the use of ultrasound (US)- Doppler before Achilles tendon tenotomy bilaterally to determine the distance between the tendon and the posterior tibial neurovascular bundle in infants with unilateral clubfoot .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Thestudy population will consist of infants aged 1 to 12 months diagnosed with unilateral idiopathic clubfoot who present to the Orthopedic and Trauma Surgery Department at Assiut University Hospitals. Each participant will have one affected (clubfoot) limb and one normal contralateral foot, allowing for within-subject comparative measurements.

Only infants with idiopathic, non-syndromic clubfoot deformity will be included to ensure homogeneity of the study group. Participants must have no history of previous foot surgery, no contralateral deformities, and no contraindications to ultrasound assessment.

Parents or legal guardians of eligible infants will receive a full explanation of the study purpose and procedures prior to enrollment. Participation will be voluntary and based on written informed consent.

A total sample of 40 infants (40 affected feet and 40 contralateral normal feet) will be recruited as a pilot population for measurement and comparison of Achilles tendon-neurovascula

Description

Inclusion Criteria:

  • Infants aged 1-6 months
  • Unilateral clubfoot deformity and a normal opposite foot

Exclusion Criteria:

  • Non-idiopathic or syndromic clubfoot
  • Previous foot surgery , contralateral foot deformity

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
clubfoot
Device: ultrasound
This study aims to assess the distance between the Achilles tendon and nearby neurovascular bundles bilaterally in infants with unilateral clubfoot deformity using ultrasound (US)- Doppler at 1 cm and 2 cm above the calcaneal tuberosity.
normal foot
Device: ultrasound
This study aims to assess the distance between the Achilles tendon and nearby neurovascular bundles bilaterally in infants with unilateral clubfoot deformity using ultrasound (US)- Doppler at 1 cm and 2 cm above the calcaneal tuberosity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AUN-ORTHO-US

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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