NCT06091371 Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation
| NCT ID | NCT06091371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Subtalar Arthrorisis |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2022-07-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06091371 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 14 Years, studying Subtalar Arthrorisis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06091371 currently recruiting?
Yes, NCT06091371 is actively recruiting participants. Contact the research team at antonio.mazzotti@ior.it for enrollment information.
Where is the NCT06091371 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06091371 clinical trial?
NCT06091371 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 55 participants.