Subtalar Extra-articular Screw Arthroereisis

Not yet recruiting

• Conditions: Flatfoot, Flexible
• Interventions: Other: Histological Analysis

• Registration Number: NCT06389253
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study Start: 2024-05
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Histological Analysis	Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old).
Study Group	Histological Analysis	Study group are patient that remove the calcaneo-stop screw (age from 14 years old)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint	Time 0 (baseline)	Number and type of nervous fibers

Trial Locations

Locations (2)

Ircss Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy

Università Vita-Salute San Raffaele; 🇮🇹 Milan, Italy