Prospective Evaluation of Treatment for Clubfoot
1 other identifier
observational
2,500
1 country
1
Brief Summary
Specific aim: To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
May 4, 2025
April 1, 2025
24.1 years
September 22, 2014
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degree of correction at initial brace wear
Dimeglio scoring system will be used (score range from 0-20)
2 months
Study Arms (3)
Surgical
Corrective Surgery only
Non-Surgical
Correction with casting, braces, Physical therapy, other non-surgical methods
Non-surgical + surgical
Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery
Interventions
non-surgical methods such as, casting, bracing, physical therapy, and other.
Combination of non-surgical methods subsequently followed by surgery
Eligibility Criteria
Primary care clinic
You may qualify if:
- Patients with a diagnosis of clubfoot deformity
- Spanish speaking patients will be eligible to participate in the study.
You may not qualify if:
- All patients without a diagnosis of clubfoot
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony I Riccio, MD
Texas Scottish Rite Hospital for Children
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 22, 2014
First Posted
October 6, 2014
Study Start
August 1, 2005
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
May 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
Data will be collected at one site, only results of data analysis will be release in publishing. Data itself will not be shared.