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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06091371

Enrollment

Registered

2023-10-19

Start date

2022-07-01

Completion date

2028-01-31

Last updated

2024-08-02

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

Conditions

Flat Feet, Growth Age, Subtalar Arthrorisis

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 14 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
AOFAS Score	At baseline (day 0)	The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score

Countries

Italy

Contacts

Primary ContactAntonio Mazzotti, MD PhD

antonio.mazzotti@ior.it0516445064

Outcome results