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Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04693065
Recruitment Status : Active, not recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

Condition or disease Intervention/treatment
Clubfoot Other: ponseti

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021

Group/Cohort Intervention/treatment
Ponseti
Patients treated by ponseti method
Other: ponseti
Standard of care, treatment by ponseti method




Primary Outcome Measures :
  1. Function at >16 years [ Time Frame: at 18 years old or complete bone maturity ]
    Composite score (perfect or non-perfect function), perfect foot defined as a plantigrade, non painful, valgus barefoot with >10° dorsal flexion. Non-perfect otherwise.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by ponseti method
Criteria

Inclusion Criteria:

  • - Patients treated by ponseti method for clubfoot-

Exclusion Criteria:

  • - other malformation associated / congenital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693065


Locations
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France
Hopital femme mere enfants
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04693065    
Other Study ID Numbers: 20_5080
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities