ClubfootNCT07473908
Ultrasound Assessment of Achilles Tendon-Neurovascular Distance in Infants With Unilateral Clubfoot
An observational study of Clubfoot, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Clubfoot
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Infants aged 1-6 months
- Unilateral clubfoot deformity and a normal opposite foot
Who cannot join
- Non-idiopathic or syndromic clubfoot
- Previous foot surgery , contralateral foot deformity
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Clubfoot
- Being tested
- ultrasound
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
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 group | Role | What they receive |
|---|---|---|
| clubfoot | Not described Receives: Device: ultrasound | |
| normal foot | Not described Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud samir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473908
- Sponsor's protocol ID
- AUN-ORTHO-US
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gutierrez Carbonell P, Navarro Amoros M, Ojeda Pena M, Pellicer Garcia V, Moril Penalver L. Ultrasound (US) measurement of the distance between the Achilles tendon and the posterior tibial neurovascular bundle in equinus infantile deformity. Skeletal Radiol. 2014 Jun;43(6):801-4. doi: 10.1007/s00256-014-1847-0. Epub 2014 Mar 13.
PubMed 24622926Hootnick DR, Packard DS Jr, Levinsohn EM. Necrosis leading to amputation following clubfoot surgery. Foot Ankle. 1990 Jun;10(6):312-6. doi: 10.1177/107110079001000605.
PubMed 2358260Dobbs MB, Gordon JE, Walton T, Schoenecker PL. Bleeding complications following percutaneous tendoachilles tenotomy in the treatment of clubfoot deformity. J Pediatr Orthop. 2004 Jul-Aug;24(4):353-7. doi: 10.1097/00004694-200407000-00002.
PubMed 15205614Jaszberenyi Z, Moriggi L, Schmidt P, Weidensteiner C, Kneuer R, Merbach AE, Helm L, Toth E. Physicochemical and MRI characterization of Gd3+-loaded polyamidoamine and hyperbranched dendrimers. J Biol Inorg Chem. 2007 Mar;12(3):406-20. doi: 10.1007/s00775-006-0197-3. Epub 2007 Jan 10.
PubMed 17216229Burghardt RD, Herzenberg JE, Ranade A. Pseudoaneurysm after Ponseti percutaneous Achilles tenotomy: a case report. J Pediatr Orthop. 2008 Apr-May;28(3):366-9. doi: 10.1097/BPO.0b013e3181653b6f.
PubMed 18362805Parada SA, Baird GO, Auffant RA, Tompkins BJ, Caskey PM. Safety of percutaneous tendoachilles tenotomy performed under general anesthesia on infants with idiopathic clubfoot. J Pediatr Orthop. 2009 Dec;29(8):916-9. doi: 10.1097/BPO.0b013e3181c18ab5.
PubMed 19934709Dogan A, Kalender AM, Seramet E, Uslu M, Sebik A. Mini-open technique for the achilles tenotomy in correction of idiopathic clubfoot: a report of 25 cases. J Am Podiatr Med Assoc. 2008 Sep-Oct;98(5):414-7. doi: 10.7547/0980414.
PubMed 18820046
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Achilles Tendon-neurovascular Distance Bilaterally in Infants With Unilateral Clubfoot Deformity
- ClinicalTrials.gov ID
- NCT07473908
- Acronym / sponsor ID
- AUN-ORTHO-US
- Conditions
- Clubfoot
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clubfoot | – | Device: ultrasound |
| normal foot | – | Device: ultrasound |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Infants aged 1-6 months
- Unilateral clubfoot deformity and a normal opposite foot
Key exclusion criteria (2 listed)
- Non-idiopathic or syndromic clubfoot
- Previous foot surgery , contralateral foot deformity
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 |
|---|---|---|
| ultrasoundThis 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. | Device | clubfoot, normal foot |
Primary outcome
To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 24622926Gutierrez Carbonell P, Navarro Amoros M, Ojeda Pena M, Pellicer Garcia V, Moril Penalver L. Ultrasound (US) measurement of the distance between the Achilles tendon and the posterior tibial neurovascular bundle in equinus infantile deformity. Skeletal Radiol. 2014 Jun;43(6):801-4. doi: 10.1007/s00256-014-1847-0. Epub 2014 Mar 13.
- Results publication: PubMed 2358260Hootnick DR, Packard DS Jr, Levinsohn EM. Necrosis leading to amputation following clubfoot surgery. Foot Ankle. 1990 Jun;10(6):312-6. doi: 10.1177/107110079001000605.
- Results publication: PubMed 15205614Dobbs MB, Gordon JE, Walton T, Schoenecker PL. Bleeding complications following percutaneous tendoachilles tenotomy in the treatment of clubfoot deformity. J Pediatr Orthop. 2004 Jul-Aug;24(4):353-7. doi: 10.1097/00004694-200407000-00002.
- Results publication: PubMed 17216229Jaszberenyi Z, Moriggi L, Schmidt P, Weidensteiner C, Kneuer R, Merbach AE, Helm L, Toth E. Physicochemical and MRI characterization of Gd3+-loaded polyamidoamine and hyperbranched dendrimers. J Biol Inorg Chem. 2007 Mar;12(3):406-20. doi: 10.1007/s00775-006-0197-3. Epub 2007 Jan 10.
- Results publication: PubMed 18362805Burghardt RD, Herzenberg JE, Ranade A. Pseudoaneurysm after Ponseti percutaneous Achilles tenotomy: a case report. J Pediatr Orthop. 2008 Apr-May;28(3):366-9. doi: 10.1097/BPO.0b013e3181653b6f.
- Results publication: PubMed 19934709Parada SA, Baird GO, Auffant RA, Tompkins BJ, Caskey PM. Safety of percutaneous tendoachilles tenotomy performed under general anesthesia on infants with idiopathic clubfoot. J Pediatr Orthop. 2009 Dec;29(8):916-9. doi: 10.1097/BPO.0b013e3181c18ab5.
- Results publication: PubMed 18820046Dogan A, Kalender AM, Seramet E, Uslu M, Sebik A. Mini-open technique for the achilles tenotomy in correction of idiopathic clubfoot: a report of 25 cases. J Am Podiatr Med Assoc. 2008 Sep-Oct;98(5):414-7. doi: 10.7547/0980414.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by Assiut University.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud samir dahesh (+201030674451, modysamir777777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07473908, which also lists 7 linked publications.
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 16 Mar 2026.