Ultrasound Assessment of Achilles Tendon-Neurovascular Distance in Infants With Unilateral Clubfoot
Measurement of Achilles Tendon-neurovascular Distance Bilaterally in Infants With Unilateral Clubfoot Deformity
1 other identifier
observational
40
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 16, 2026
March 1, 2026
1.4 years
March 11, 2026
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To measure the distance between the Achilles tendon and: • The posterior tibial neurovascular bundle In the clubfoot vs the normal foot
baseline
Study Arms (2)
clubfoot
normal foot
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- Infants aged 1-6 months
- Unilateral clubfoot deformity and a normal opposite foot
You may not qualify if:
- Non-idiopathic or syndromic clubfoot
- Previous foot surgery , contralateral foot deformity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
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.
PMID: 24622926RESULTHootnick 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.
PMID: 2358260RESULTDobbs 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.
PMID: 15205614RESULTJaszberenyi 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.
PMID: 17216229RESULTBurghardt 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.
PMID: 18362805RESULTParada 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.
PMID: 19934709RESULTDogan 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.
PMID: 18820046RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
March 11, 2026
First Posted
March 16, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03