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RecruitingNCT02257229Updated May 4, 2025

Prospective Evaluation of Treatment for Clubfoot

An observational study in Clubfoot Deformity, sponsored by Texas Scottish Rite Hospital for Children. Recruiting at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by Texas Scottish Rite Hospital for Children · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
Up to 18 Years
Sex
All
01

Study summary

Specific aim:

To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions

Read the detailed description

PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol for the collection of relevant clinical and functional outcome measures on our patients with a diagnosis of clubfoot.

02

Conditions studied

  • Clubfoot Deformity

Keywords

  • Clubfoot, deformity, correction, management, gait
03

In context

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 55 across 27 observational studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

Texas Scottish Rite Hospital for Children is the lead sponsor of 18 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a diagnosis of clubfoot deformity
  • Spanish speaking patients will be eligible to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • All patients without a diagnosis of clubfoot
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgical

    Corrective Surgery only

    Procedure: Surgical

  • Non-Surgical

    Correction with casting, braces, Physical therapy, other non-surgical methods

    Procedure: Non-Surgical

  • Non-surgical + surgical

    Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery

    Procedure: Non-surgical + surgical

Interventions

  • ProcedureSurgical

    Surgery only

  • ProcedureNon-Surgical

    non-surgical methods such as, casting, bracing, physical therapy, and other.

  • ProcedureNon-surgical + surgical

    Combination of non-surgical methods subsequently followed by surgery

06

What researchers measure

Primary outcomes

  1. Degree of correction at initial brace wear

    Dimeglio scoring system will be used (score range from 0-20)

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Data will be collected at one site, only results of data analysis will be release in publishing. Data itself will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02257229
Lead sponsor
Texas Scottish Rite Hospital for Children
Responsible party
Anthony Riccio (Principal Investigator, Texas Scottish Rite Hospital for Children) — Principal investigator
First posted
Oct 6, 2014
Start date
Aug 2005
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
May 4, 2025

Study contacts

Rusty Hartman, MS
Contact
rusty.hartman@tsrh.org
214-559-8371
Jessica L Phillips, MPH
Contact
jessica.laureano-phillips@tsrh.org
12145598562
Anthony I Riccio, MD
principal investigator · Texas Scottish Rite Hospital for Children

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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