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

Foot Deformities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312828
• Other study ID #: 2019-A02916-51
• Status: Completed
• Start date: July 18, 2020
• Est. completion date: June 23, 2022

Study information

• Verified date: August 2022
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foot Deformities

Intervention

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

Locations

Country	Name	City	State
France	Clinique Marcel SEMBAT	Boulogne-billancourt

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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