An observational study in Pediatric Flexible Flatfoot, sponsored by University of Pavia. Active, not recruiting at 1 site in Italy. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Pavia · Observational
Flexible flatfoot is common in children and adolescents. In some patients, the condition remains painful or limits activity despite non-surgical treatment. Subtalar arthroereisis is a minimally invasive operation in which an implant is placed in the sinus tarsi to limit excessive foot pronation while preserving joint movement.
This observational study follows children and adolescents who receive subtalar arthroereisis as part of their planned clinical care. Clinical status, standing foot radiographs, plantar-pressure distribution, and walking characteristics are assessed before surgery and six months after surgery. The study aims primarily to describe changes in dynamic plantar loading and walking parameters. Changes in clinical scores and radiographic alignment are assessed as secondary outcomes. No treatment is assigned for research purposes, and all surgical and postoperative decisions are made according to routine clinical indications.
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's enrollment of 25 is below the median of 47 across 48 observational studies indexed under Flatfoot.
Browse Flatfoot studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pediatric patients aged 10 to 18 years with symptomatic flexible flatfoot referred to the participating orthopedic unit and scheduled for elective subtalar arthroereisis after failure of appropriate conservative management or because of persistent symptoms, progressive deformity, or substantial functional impairment.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and adolescents aged 10 to 18 years with symptomatic flexible flatfoot and a clinical indication for elective subtalar arthroereisis. Participants receive the operation as part of routine clinical care and undergo clinical, radiographic, and dynamic baropodometric assessment before surgery and at six months after surgery.
Procedure: Subtalar Arthroereisis
A conical titanium implant is inserted into the sinus tarsi through a minimally invasive approach to restrict excessive subtalar pronation while preserving joint mobility. Implant size and position are assessed clinically and under fluoroscopic guidance. Additional soft-tissue or navicular procedures may be performed when clinically indicated, including gastrocnemius lengthening; excision or regularization of a symptomatic accessory or prominent navicular; posterior tibial tendon reinsertion or retensioning; or anterior tibial tendon tenosuspension according to the Young technique. These procedures are determined by clinical need and are not assigned by the study protocol.
Step-Cycle Duration
Time frame: Baseline and 6 months after surgery
Ground-Contact Duration
Time frame: Baseline and 6 months after surgery
Double-Support Duration
Time frame: Baseline and 6 months after surgery
Step Length
Time frame: Baseline and 6 months after surgery
Anteroposterior Talonavicular Coverage Angle Measured on Weight-Bearing Radiographs Using Synapse
The anteroposterior talonavicular coverage angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Time frame: Baseline and 6 months after surgery
Anteroposterior Talocalcaneal Angle Measured Using Synapse
The anteroposterior talocalcaneal angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Time frame: Baseline and 6 months after surgery
Lateral Meary's Angle Measured Using Synapse
The lateral Meary's angle will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Time frame: Baseline and 6 months after surgery
Lateral Calcaneal Pitch Measured Using Synapse
The lateral calcaneal pitch will be measured in degrees using the Synapse software on radiographic images. The measurement will be performed at baseline, before surgery (T0), and approximately 6 months after surgery (T1), in the operated foot. The change from baseline to 6 months after surgery will be evaluated.
Time frame: Baseline and 6 months after surgery
Plan to share: Undecided
Started Apr 2026 (actual). Primary completion is estimated for Jan 2027, 9 months after the start.
Of 16 observational studies under Flatfoot, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 25. This study's planned 9 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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