Prospective Evaluation of Treatment for Clubfoot

Texas Scottish Rite Hospital for Children

Status: Enrolling

Conditions: Clubfoot Deformity

Treatments: Procedure: Non-Surgical; Procedure: Surgical; Procedure: Non-surgical + surgical

Study type: Observational

Funder types: Other

Identifiers

NCT02257229

032011-131

Details and patient eligibility

About

Specific aim:

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

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 3 patient groups

Surgical

Description:

Corrective Surgery only

Treatment:

Procedure: Surgical

Non-Surgical

Description:

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

Treatment:

Procedure: Non-Surgical

Non-surgical + surgical

Description:

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

Treatment:

Procedure: Non-surgical + surgical