Assessment of Orthopedic Care of the Z-shaped Foot in Infant

NCT ID: NCT04312828

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-18

Study Completion Date

2022-06-23

Brief Summary

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Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.

Detailed Description

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The study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. This collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents.

Early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.

Conditions

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Foot Deformities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Orthopedic management of the Z-foot

Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Child having presented a congenital idiopathic malformation uni- or bilateral of foot in Z, defined by the presence of an angular adduction of the mid-forefoot and a dorsolateral hump;
* Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention, having started at least 9 months before inclusion;
* Child aged 6 months to 2 years at the start of care;
* Authorization of the parents or the legal representative of the child to collect personal information about their child.

Exclusion Criteria

* Child having presented a secondary Z foot;
* History of foot surgery;
* Lack of retrospective data to assess the convexity of the external edge of the foot before orthopedic care;
* Inability of the parents or the child's legal representative to understand the study protocol.
Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mira MD RAMANOUDJAME

Role: PRINCIPAL_INVESTIGATOR

Clinique Marcel SEMBAT

Locations

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Clinique Marcel SEMBAT

Boulogne-Billancourt, , France

Site Status

Countries

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France

Other Identifiers

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2019-A02916-51

Identifier Type: -

Identifier Source: org_study_id

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