Prospective Evaluation of Treatment for Clubfoot

NCT ID: NCT02257229

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2029-09-30

Brief Summary

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Specific aim:

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

Detailed Description

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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.

Conditions

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Clubfoot Deformity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical

Corrective Surgery only

Surgical

Intervention Type PROCEDURE

Surgery only

Non-Surgical

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

Non-Surgical

Intervention Type PROCEDURE

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

Non-surgical + surgical

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

Non-surgical + surgical

Intervention Type PROCEDURE

Combination of non-surgical methods subsequently followed by surgery

Interventions

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Surgical

Surgery only

Intervention Type PROCEDURE

Non-Surgical

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

Intervention Type PROCEDURE

Non-surgical + surgical

Combination of non-surgical methods subsequently followed by surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Scottish Rite Hospital for Children

OTHER

Sponsor Role lead

Responsible Party

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Anthony Riccio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony I Riccio, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Scottish Rite Hospital for Children

Locations

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Texas Scottish Rite Hospital for Children

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rusty Hartman, MS

Role: CONTACT

214-559-8371

Jessica L Phillips, MPH

Role: CONTACT

12145598562

Facility Contacts

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Rusty Hartman, MS

Role: primary

214-559-8371

Other Identifiers

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032011-131

Identifier Type: -

Identifier Source: org_study_id

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