Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Idiopathic, flexible, symptomatic flatfoot
- Patients aged between 8 and 14 years
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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