An observational study in Flatfoot, Flexible, sponsored by Università Vita-Salute San Raffaele. Not yet recruiting at 2 sites in Italy. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Università Vita-Salute San Raffaele · Observational
The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi.
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's planned enrollment of 40 is below the median of 47 across 48 observational studies indexed under Flatfoot.
Browse Flatfoot studies →Università Vita-Salute San Raffaele is the lead sponsor of 85 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with subtalar extraarticular screw arthroereisis, gender male and female, no comorbidities.
Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old).
Study group are patient that remove the calcaneo-stop screw (age from 14 years old)
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.
Study Group:
Control Group:
Exclusion Criteria:
Control Group:
Study Group:
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.
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.
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.
Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old).
Other: Histological Analysis
Study group are patient that remove the calcaneo-stop screw (age from 14 years old)
Other: Histological Analysis
For the study, a minimal part of the periarticular tissue, specifically the sinus tarsi juxta-articular fatty tissue, that is normally dissected and discarded during the surgical operation of insertion and removal of the calcaneo-stop screw, will be analyzed
Primary Endpoint (%)
Percentage of patients presenting at least one proprioceptive fibers in the pericapsular tissue
Time frame: Time 0 (baseline)
Secondary Endpoint
Number and type of nervous fibers
Time frame: Time 0 (baseline)
Plan to share: No
Start is estimated for May 2024; primary completion for May 2025, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Università Vita-Salute San Raffaele