UnknownNot Applicable

Subtalar Extra-articular Screw Arthroereisis

Italy40 participantsStarted 2024-05

Plain-language summary

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.

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Study Group: * Patients aged 14 years old and above that will remove the calcaneo stop screw, in place for at least 3 years after the implant, will be recruited * Patients willing and able to give informed consent for the participation in the study. For underage patients, a parent/legal representative will give consent for the participation in the study. * Male and female patients in fertile age can be recruited. Control Group: * Syndromic patients * Previous foot malformation (synostosis, congenital clubfoot) * Female participant who is pregnant, lactating or planning pregnancy during the course of the study. Exclusion Criteria: Control Group: * Syndromic patients * Previous foot malformation (synostosis, congenital clubfoot) * Female participant who is pregnant, lactating or planning pregnancy during the course of the study. Study Group: * Patients suffering from post-operative complications * Syndromic patients * Previous foot malformation (synostosis, congenital clubfoot) * Female participant who is pregnant, lactating or planning pregnancy during the course of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Endpoint (%)

Timeframe: Time 0 (baseline)

Trial details

NCT IDNCT06389253

SponsorUniversità Vita-Salute San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05

View on ClinicalTrials.gov More Flatfoot, Flexible trials