Prospective Evaluation of Treatment for Clubfoot

Clubfoot Deformity Clinical Trial

Official title:

Prospective Evaluation of Treatment for Clubfoot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02257229
• Other study ID #: 032011-131
• Status: Recruiting
• Start date: August 2005
• Est. completion date: September 2029

Study information

• Verified date: May 2024
• Source: Texas Scottish Rite Hospital for Children
• Contact: Rusty Hartman, MS
• Phone: 214-559-8371
• Email: rusty.hartman[@]tsrh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Specific aim:

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Clubfoot
• Clubfoot Deformity
• Congenital Abnormalities
• Equinus Deformity
• Foot Deformities

Intervention

Procedure:
• Surgical
Surgery only
• Non-Surgical
non-surgical methods such as, casting, bracing, physical therapy, and other.
• Non-surgical + surgical
Combination of non-surgical methods subsequently followed by surgery

Locations

Country	Name	City	State
United States	Texas Scottish Rite Hospital for Children	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Scottish Rite Hospital for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of correction at initial brace wear	Dimeglio scoring system will be used (score range from 0-20)	2 months