ClinicalTrials.gg
CompletedNCT03372642Updated Dec 15, 2017

Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

An observational study in Flatfoot and Pediatric ALL, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-12-15.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
14 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's enrollment of 60 is above the median of 47 across 48 observational studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We retrospectively review 60 consecutive patients who underwent surgical treatment with subtalar arthroereisis for pediatric flexible flatfoot at the authors' institution from January 2011 to March 2015.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Subtalar endorthesis

    Patients who underwent subtalar endorthesis for flexible pediatric flatfoot

    Device: Subtalar endorthesis

Interventions

  • DeviceSubtalar endorthesis

    Subtalar arthroereisis with endorthesis for pediatric flexible flat foot

06

What researchers measure

Primary outcomes

  1. lateral talocalcaneal angle

    lateral 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

    Time frame: 1 day

Secondary outcomes

  1. AOFAS

    American 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.

    Time frame: 1 day

  2. SEFAS

    Self-reported foot and ankle score (SEFAS)

    Time frame: 1 day

  3. SF-12

    12-Item Short Form Health Survey (SF-12) with its Mental and Physical Component Scores (MCS and PCS)

    Time frame: 1 day

  4. Meary's angle

    Meary'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

    Time frame: 1 day

  5. Calcaneal pitch angle

    Calcaneal 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

    Time frame: 1 day

  6. Anteroposterior talonavicular coverage angle

    Anteroposterior 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

    Time frame: 1 day

  7. Talonavicular uncoverage percent

    Talonavicular 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

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03372642
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Mar 1, 2016
Primary completion
Jan 16, 2017
Completion
Feb 20, 2017
Last update
Dec 15, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion