- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07569835
Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot (ARTRO-LONG)
VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle).
The secondary efficacy endpoint will be the absence of pain at follow-up, assessed using the VAS scale, and evaluation of the footprint using a podoscope.
TIP-TOE TEST:
The patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tip-toe.
JACK TEST:
This consists of passive dorsiflexion of the hallux under weight-bearing conditions. If the previously absent arch reappears, the flatfoot is considered flexible.
TIP-TOE WALKING TEST:
The patient walks for about ten steps on tip-toe. The examiner observes any varus alignment of the hindfoot and reconstruction of the plantar arch.
MEARY'S ANGLE:
Measured between the longitudinal axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph.
TALOCALCANEAL ANGLE:
Measured between the longitudinal axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.
VAS:
The Visual Analog Scale for pain is a tool used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).
PODOSCOPE FOOTPRINT ASSESSMENT:
Evaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the forefoot.
SAMPLE SIZE AND STATISTICS In Prof. Giannini's study, 30 patients were enrolled; approximately 30% were lost to follow-up over 12 years. Barring further losses, about 20 patients currently followed at Clinic I are expected to be available.
ENROLLMENT PROCEDURE Eligible patients will be enrolled in the study only after providing written informed consent. No data collection, procedures, or analyses will be performed prior to obtaining consent.
DATA COLLECTION Clinical data required for the study will be extracted from patients' medical records and source documents.
A dedicated data collection form will be used to record clinical information and the results of the analyses by the study.
For each enrolled patient, a Case Report Form (CRF) will be completed.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Antonio Mazzotti Prof
- Telefonní číslo: +39 3498798863
- E-mail: antonio.mazzotti@ior.it
Studijní místa
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-
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Bologna, Itálie
- Nábor
- Istituto Ortopedico Rizzoli
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Kontakt:
- Antonio Mazzotti Prof
- Telefonní číslo: +39 3498798863
- E-mail: antonio.mazzotti@ior.it
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Primary objective:
To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot.
Secondary objectives:
To compare, within the same patient, the clinical and radiological outcomes of feet treated with subtalar arthroereisis using calcaneostop versus endorthosis.
Popis
INCLUSION CRITERIA:
Patients already in follow-up after undergoing subtalar arthroereisis with calcaneostop and endorthosis, enrolled in the study "Flatfoot treatment: comparison between resorbable endorthosis and resorbable calcaneal stop" by Prof. Giannini, still in follow-up at IOR.
EXCLUSION CRITERIA:
Patients who have undergone subsequent surgical procedures on the foot and ankle
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
patients who underwent subtalar arthroereisis with calcaneostop and endorthosis
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To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
VAS (Visual Analog Scale)
Časové okno: may 2024 may 2027
|
A scale used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).
|
may 2024 may 2027
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
MEARY'S ANGLE
Časové okno: may 2024 may 2027
|
Measured between the axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph
|
may 2024 may 2027
|
|
TALO-CALCANEAL ANGLE
Časové okno: may 2024 may 2027
|
Measured between the axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.
|
may 2024 may 2027
|
|
TIP-TOE TEST
Časové okno: may2024 - may 2027
|
The patient is observed under weight-bearing conditions and then while rising onto the toes.
If the foot is flexible, the plantar arch-previously absent-reappears when standing on tiptoe.
|
may2024 - may 2027
|
|
jACK TEST
Časové okno: may 2024 - may 2027
|
this consists of passive extension of the big toe under weight-bearing.
If the previously absent arch reappears, the flatfoot is flexible.
|
may 2024 - may 2027
|
|
TIPTOE WALKING
Časové okno: may 2024 - may 2027
|
The patient walks for about ten steps on tiptoe, and the examiner observes any varus alignment of the hindfoot and the reformation of the plantar arch.
|
may 2024 - may 2027
|
|
PODOSCOPE FOOTPRINT ASSESSMENT
Časové okno: may 2024 - may 2027
|
Evaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot).
The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the
|
may 2024 - may 2027
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ARTRO-LONG
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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