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Prospective Evaluation of Treatment for Clubfoot

Prospective Evaluation of Treatment for Clubfoot

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02257229
Enrollment
2500
Registered
2014-10-06
Start date
2005-08-31
Completion date
2029-09-30
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clubfoot Deformity

Keywords

Clubfoot, deformity, correction, management, gait

Brief summary

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

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.

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

Sponsors

Texas Scottish Rite Hospital for Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* All patients without a diagnosis of clubfoot

Design outcomes

Primary

MeasureTime frameDescription
Degree of correction at initial brace wear2 monthsDimeglio scoring system will be used (score range from 0-20)

Countries

United States

Contacts

Primary ContactRusty Hartman, MS
rusty.hartman@tsrh.org214-559-8371
Backup ContactJessica L Phillips, MPH
jessica.laureano-phillips@tsrh.org12145598562

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026