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

NCT04312828 | Completed

• 1 other identifier: 2019-A02916-51
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Foot Deformities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Moderate success rate of the procedure

  9 months

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

  9 months

• Convex angle of the outer edge of the foot during follow-up

  9 months

Interventions

Orthopedic management of the Z-foot PROCEDURE

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

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique Marcel SEMBAT

Boulogne-Billancourt, France

Location

MeSH Terms

Conditions

Foot Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Mira MD RAMANOUDJAME

  Clinique Marcel SEMBAT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: July 18, 2020
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)