Actively Recruiting

Age: 8Years - 14Years
All Genders
Healthy Volunteers
ID06091371

Prospective Evaluation of Patients Undergoing Surgical Treatment for Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for the Treatment of Flexible Flatfoot in the Growth Age

Led by Istituto Ortopedico Rizzoli · Updated on 2024-08-02

55

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating surgical treatment called arthrorisis of the subastragalus joint using a polymeric implant to address flexible flatfoot in children aged 8 to 14 years. This condition involves joint deformity causing flat feet, and the study aims to analyze clinical and radiographic outcomes over time during growth. The trial is a prospective observational study involving 55 patients to better understand the treatment's effects. The surgical procedure uses a polymeric endorthesis designed to restore proper alignment between the astragalus and calcaneus bones and maintain this correction over time. The goal is to allow natural bone remodeling along growth lines, usually within a few years. This study tracks patients undergoing this specific surgery without comparing other treatments. Participants will be monitored regularly with measurements of Meary's angle at baseline and multiple follow-up points up to 72 months after surgery. Additionally, the American Orthopaedic Foot & Ankle Society (AOFAS) scores will be assessed at the same intervals. These evaluations help assess the joint alignment and foot function over time. The study will continue collecting data and monitoring outcomes until 2028.

CONDITIONS

Brief Title

Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation

Who Can Participate

Age: 8Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Idiopathic, flexible, symptomatic flatfoot
  • Patients aged between 8 and 14 years
Not Eligible

You will not qualify if you...

  • Joint laxity
  • Neuromuscular disorders
  • Neurological conditions
  • Traumatic sequelae
  • Iatrogenic flatfoot
  • Congenital flatfoot due to tarsal synostosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 72 months

Participants who undergo routine care are observed to assess outcomes related to flexible flatfoot treatment over time.

Visits at baseline, 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 72 months

Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

Loading map...

Research Team

A

Antonio Mazzotti, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial