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

August 12, 2022 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-billancourt, France
        • Clinique Marcel SEMBAT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who suffered from a congenital idiopathic Z-foot deformation, aged 6 months to 2 years at the time of orthopedic treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

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.
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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
9 months
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.
9 months
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 ° ).
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Mira MD RAMANOUDJAME, Clinique Marcel SEMBAT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2020

Primary Completion (Actual)

June 23, 2022

Study Completion (Actual)

June 23, 2022

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02916-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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