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Recruiting Observational

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

NCT06091371 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-07-01
Last updated
2024-08-02

Condition(s) studied

Subtalar ArthrorisisFlat FeetGrowth Age

Study summary

Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years.

Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.

Eligibility

Sex
ALL
Min age
8 Years
Max age
14 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Idiopathic, flexible, symptomatic flatfoot * Patients aged between 8 and 14 years Exclusion Criteria: * Joint laxity * Neuromuscular disorders * Neurological conditions * Traumatic sequelae * Iatrogenic flatfoot * Congenital flatfoot due to tarsal synostosis

Primary outcome measure(s)

  • Meary's angle — At baseline (day 0)
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 1 month
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 3 months
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 6 months
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 12 months
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 24 months
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 36 months
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 48 months
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.
  • Meary's angle — After 72 months
    Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06091371 on ClinicalTrials.gov ↗ ← All trials in Italy