Recruiting

Clubfoot Treatment

Sponsor:

Texas Scottish Rite Hospital for Children

Code:

NCT02257229

Conditions

Clubfoot Deformity

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Surgical

Non-Surgical

Non-surgical + surgical

Study Details

Brief summary:

Specific aim:

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

Conditions

Clubfoot Deformity

Study ID

NCT02257229

Start date

Aug, 2005

Status verified date

Apr, 2025

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical

Corrective Surgery only

Non-Surgical

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

Non-surgical + surgical

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

Interventions

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

Primary outcome measure

  • Degree of correction at initial brace wear [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Rusty Hartman, MS

214-559-8371rusty.hartman@tsrh.org

Jessica L Phillips, MPH

12145598562jessica.laureano-phillips@tsrh.org

Locations

Texas Scottish Rite Hospital for Children

Recruiting

Dallas, Texas, United States, 75219

Contacts

Rusty Hartman, MS

214-559-8371rusty.hartman@tsrh.org

Principal Investigator:

Anthony I Riccio, MD

More Information

Sponsor

Texas Scottish Rite Hospital for Children

Last update posted

May 4, 2025

Last verified

Apr, 2025

Keywords

  • Clubfoot, deformity, correction, management, gait

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Scottish Rite Hospital for Children on 2025-05-04.