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Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

Valutazione Dell'Efficacia Dell'Endortesi Senotarsica Nella Correzione Della Sindrome Pronatoria Nel Bambino (Flatfoot)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03372642
Enrollment
60
Registered
2017-12-13
Start date
2016-03-01
Completion date
2017-02-20
Last updated
2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flatfoot, Pediatric ALL

Brief summary

Pediatric flexible flatfoot is sometimes asymptomatic but it can also cause physical impairment, pain, and difficulty walking. We evaluate the radiographic effectiveness of intervention of subtalar arthroereisis with endorthesis for pediatric flexible flatfoot with final follow-up at skeletal maturity.

Interventions

DEVICESubtalar endorthesis

Subtalar arthroereisis with endorthesis for pediatric flexible flat foot

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Males and females * age ≥ 14 years at the time of the visit * patients who underwent subtalar endothesis for the treatment of the pediatric flexible flatfoot from January 2011 to March 2015.

Exclusion criteria

* age \<14 years at the time of the visit * patients with comorbidities that make it difficult to return to the hospital for consultation or who have removed the device for discomfort * female patients who do not exclude (by self-declaration, as clinical practice) a state of pregnancy

Design outcomes

Primary

MeasureTime frameDescription
lateral talocalcaneal angle1 daylateral talocalcaneal angle (LTC) on the lateral view of the radiographs: it is traced between the long axis of the talus and the plantar surface of the calcaneus

Secondary

MeasureTime frameDescription
SEFAS1 daySelf-reported foot and ankle score (SEFAS)
SF-121 day12-Item Short Form Health Survey (SF-12) with its Mental and Physical Component Scores (MCS and PCS)
Meary's angle1 dayMeary's angle (MA) on the lateral view of the radiographs, also known as talar-first metatarsal angle: it is formed by a line through the long axis of the talus and the axis of the first metatarsal (the negative values indicate a plantar apex of the angle as it happens in the flatfeet
AOFAS1 dayAmerican Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale. It is a measure of ankle and hidfoot function. It comprises nine questions and covers three categories: pain (40 points), function (50 points) and alignment (10 points). These are all summed together for a maximun score of 100 points (best otucome) and a minimum score of 0 (worst outcome). It includes a mixture of questions that are both subjective and objective in nature.
Anteroposterior talonavicular coverage angle1 dayAnteroposterior talonavicular coverage angle (APTN) on the anteroposterior view of the radiographs: it is the angle between the lines connecting the endpoints of the talar and navicular articular surfaces
Talonavicular uncoverage percent1 dayTalonavicular uncoverage percent (TNU) on the anteroposterior view of the radiographs: it is a ratio between the angle subtended by the line connecting the endpoints of the talar articular surface and a line drawn from the midpoint of the previous line and the medial endpoint of the navicular articular surface. It indicates the percentage of the talar head not covered by the navicular
Calcaneal pitch angle1 dayCalcaneal pitch angle on the lateral view of the radiographs: it is subtended by the intersection of a line parallel to the floor with a line connecting the two most inferior points on the calcaneus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026