Prospective Evaluation of Treatment for Clubfoot

Recruiting

• Conditions: Clubfoot Deformity

• Registration Number: NCT02257229
• Lead Sponsor: Texas Scottish Rite Hospital for Children

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2029-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of correction at initial brace wear	2 months	Dimeglio scoring system will be used (score range from 0-20)

Trial Locations

Locations (1)

Texas Scottish Rite Hospital for Children; 🇺🇸 Dallas, Texas, United States