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

Flat Feet Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091371
• Other study ID #: EPProsp
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: January 2028

Study information

• Verified date: October 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Antonio Mazzotti, MD PhD
• Phone: 0516445064
• Email: antonio.mazzotti[@]ior.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: January 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Flat Feet
• Flatfoot

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. 2004 May-Jun;43(3):144-55. doi: 10.1053/j.jfas.2004.03.012. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meary's angle		At baseline (day 0)
Primary	Meary's angle		After 1 month
Primary	Meary's angle		After 3 months
Primary	Meary's angle		After 6 months
Primary	Meary's angle		After 12 months
Primary	Meary's angle		After 24 months
Primary	Meary's angle		After 36 months
Primary	Meary's angle		After 48 months
Primary	Meary's angle		After 72 months
Secondary	AOFAS Score		At baseline (day 0)
Secondary	AOFAS Score		After 1 month
Secondary	AOFAS Score		After 3 months
Secondary	AOFAS Score		After 6 months
Secondary	AOFAS Score		After 12 months
Secondary	AOFAS Score		After 24 months
Secondary	AOFAS Score		After 36 months
Secondary	AOFAS Score		After 48 months
Secondary	AOFAS Score		After 72 months