Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Subtalar Arthrorisis, Flat Feet, Growth Age. Basic parameters: 8 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Meary's angle [Time frame: At baseline (day 0)]
- Meary's angle [Time frame: After 1 month]
- Meary's angle [Time frame: After 3 months]
- Meary's angle [Time frame: After 6 months]
- Meary's angle [Time frame: After 12 months]
- Meary's angle [Time frame: After 24 months]
- Meary's angle [Time frame: After 36 months]
- Meary's angle [Time frame: After 48 months]
- Meary's angle [Time frame: After 72 months]
Secondary outcome measures (9)
- AOFAS Score [Time frame: At baseline (day 0)]
- AOFAS Score [Time frame: After 1 month]
- AOFAS Score [Time frame: After 3 months]
- AOFAS Score [Time frame: After 6 months]
- AOFAS Score [Time frame: After 12 months]
- AOFAS Score [Time frame: After 24 months]
- AOFAS Score [Time frame: After 36 months]
- AOFAS Score [Time frame: After 48 months]
- AOFAS Score [Time frame: After 72 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Publications
- 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. PMID 15181430
Identifiers
NCT: NCT06091371 · EPProsp