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Recruiting

NCT Number: NCT02257229

Prospective Evaluation of Treatment for Clubfoot

Specific aim:

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

Recruiting

Interested in participating?

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Key information

Conditions

Clubfoot Deformity Clubfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location status: Recruiting

Location contact

Anthony I Riccio, MD

PRINCIPAL_INVESTIGATOR

Rusty Hartman, MS

CONTACT

[email protected]

214-559-8371

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical

Procedure

Surgery only

Non-Surgical

Procedure

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

Non-surgical + surgical

Procedure

Combination of non-surgical methods subsequently followed by surgery

Primary outcomes

  1. Degree of correction at initial brace wear

    Time frame: 2 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica L Phillips, MPH

CONTACT

[email protected]

12145598562

Rusty Hartman, MS

CONTACT

[email protected]

214-559-8371

Sponsors and collaborators

Lead sponsor

Texas Scottish Rite Hospital for Children

Other

Registry information

Important dates

Study start
2005
Primary completion
2029
Study completion
2029
First posted
Oct 6, 2014
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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