NCT04693065

Brief Summary

We aim at finding prognostic factors of long term (after growth) function outcome in patient with clubfoot treated by ponseti method, based on a very complete prospective recording of treatment variables and outcome

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 5, 2021

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 18, 2020

Last Update Submit

December 31, 2020

Conditions

Clubfoot

Outcome Measures

Primary Outcomes (1)

  • Function at >16 years

    Composite score (perfect or non-perfect function), perfect foot defined as a plantigrade, non painful, valgus barefoot with \>10° dorsal flexion. Non-perfect otherwise.

    at 18 years old or complete bone maturity

Study Arms (1)

Ponseti

Patients treated by ponseti method

Other: ponseti

Interventions

ponsetiOTHER

Standard of care, treatment by ponseti method

Ponseti

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated by ponseti method

You may qualify if:

  • \- Patients treated by ponseti method for clubfoot-

You may not qualify if:

  • \- other malformation associated / congenital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital femme mere enfants

Lyon, France

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

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

Study Record Dates

First Submitted

September 18, 2020

First Posted

January 5, 2021

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

June 1, 2021

Last Updated

January 5, 2021

Record last verified: 2020-09

Locations

FR(1)