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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
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
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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