Subtalar Extra-articular Screw Arthroereisis

Subtalar Extra-articular Screw Arthroereisis: How Does the Screw Work

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06389253

Enrollment

Registered

2024-04-29

Start date

2024-05-31

Completion date

2025-05-31

Last updated

2024-05-01

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

Conditions

Flatfoot, Flexible

Brief 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.

Interventions

OTHERHistological 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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary Endpoint (%)	Time 0 (baseline)	Percentage of patients presenting at least one proprioceptive fibers in the pericapsular tissue

Secondary

Measure	Time frame	Description
Secondary Endpoint	Time 0 (baseline)	Number and type of nervous fibers

Countries

Italy

Outcome results

None listed

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