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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06091371
Other study ID # EPProsp
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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