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Completed

NCT Number: NCT04312828

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

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.

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Key information

Conditions

Foot Deformities Musculoskeletal Diseases

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Marcel SEMBAT

Boulogne-Billancourt, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthopedic management of the Z-foot

Procedure

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

Primary outcomes

  1. The main criterion of the study is the success rate of orthopedic management of the Z-foot.

    Time frame: 9 months

    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.

Secondary outcomes

  1. Moderate success rate of the procedure

    Time frame: 9 months

    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)

  2. Partial and total success rate (relative to the number of patients treated)

    Time frame: 9 months

    • 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.

  3. Convex angle of the outer edge of the foot during follow-up

    Time frame: 9 months

    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 ° ).

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2020
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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