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

Not yet recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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

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

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
Intervention / Treatment
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

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

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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