- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Antonio Mazzotti Prof
- 전화번호: +39 3498798863
- 이메일: antonio.mazzotti@ior.it
연구 장소
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Bologna, 이탈리아
- 모병
- Istituto Ortopedico Rizzoli
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연락하다:
- Antonio Mazzotti Prof
- 전화번호: +39 3498798863
- 이메일: antonio.mazzotti@ior.it
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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VAS (Visual Analog Scale)
기간: may 2024 may 2027
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A scale used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).
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may 2024 may 2027
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MEARY'S ANGLE
기간: may 2024 may 2027
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Measured between the axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph
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may 2024 may 2027
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TALO-CALCANEAL ANGLE
기간: may 2024 may 2027
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Measured between the axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.
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may 2024 may 2027
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TIP-TOE TEST
기간: may2024 - may 2027
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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
기간: may 2024 - may 2027
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this consists of passive extension of the big toe under weight-bearing.
If the previously absent arch reappears, the flatfoot is flexible.
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may 2024 - may 2027
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TIPTOE WALKING
기간: may 2024 - may 2027
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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.
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may 2024 - may 2027
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PODOSCOPE FOOTPRINT ASSESSMENT
기간: may 2024 - may 2027
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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
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may 2024 - may 2027
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
calcaneo stop and endorthesis에 대한 임상 시험
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Istituto Ortopedico Rizzoli완전한