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

Study Overview
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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.

Official Title
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Assessment of Orthopedic Care of the Z-shaped Foot in Children From 6 Months to 2 Years Old

Conditions
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Foot Deformities

Intervention / Treatment
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* Procedure: Orthopedic management of the Z-foot


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Orthopedic management of the Z-foot|Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main criterion of the study is the success rate of orthopedic management of the Z-foot. | Success is a composite criterion, measured at the last follow-up, defined by: Outer edge of the straight foot; AND Absence of dorsolateral hump OR possibility of putting on shoes without difficulty AND Absence of recurrence of the malformation OR resumption of surgery OR resumption of orthopedic treatment. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate success rate of the procedure | Defined by an external edge of the foot that is not rectilinear but the possibility of normal footwear, at the greatest distance (relative to the number of feet treated) | 9 months | 
| Partial and total success rate (relative to the number of patients treated) | Total success rate: (number of patients with unilateral involvement and foot treated successfully + number of patients with bilateral involvement and both feet treated successfully) / total number of patients. Partial success rate in patients with bilateral involvement: number of patients with only one of the 2 feet treated successfully / number of patients with bilateral involvement. | 9 months | 
| Convex angle of the outer edge of the foot during follow-up | The evolution of the convexity angle of the external edge of the foot will be studied during treatment and follow-up, in a mixed model with repeated measurements, with the initial severity of the malformation as a cofactor (angle ≤ 15 ° /> 15 ° ). | 9 months |