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

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Recruiting

CT.gov ID

NCT06091371

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subtalar Arthrorisis Flat Feet Growth Age

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

55 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Jan 1, 2028

Outcome Measures

Primary Outcome Measures

Meary's angle [At baseline (day 0)]
Meary's angle [After 1 month]
Meary's angle [After 3 months]
Meary's angle [After 6 months]
Meary's angle [After 12 months]
Meary's angle [After 24 months]
Meary's angle [After 36 months]
Meary's angle [After 48 months]
Meary's angle [After 72 months]

Secondary Outcome Measures

AOFAS Score [At baseline (day 0)]
AOFAS Score [After 1 month]
AOFAS Score [After 3 months]
AOFAS Score [After 6 months]
AOFAS Score [After 12 months]
AOFAS Score [After 24 months]
AOFAS Score [After 36 months]
AOFAS Score [After 48 months]
AOFAS Score [After 72 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Ortopedico Rizzoli	Bologna		Italy	40136

Sponsors and Collaborators

Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antonio Mazzotti, MD, PhD, Istituto Ortopedico Rizzoli

ClinicalTrials.gov Identifier:

NCT06091371

Other Study ID Numbers:

EPProsp

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Flatfoot

Study Results

No Results Posted as of Oct 19, 2023