Prospective Evaluation of Treatment for Clubfoot

April 10, 2023 updated by: Anthony Riccio, Texas Scottish Rite Hospital for Children

Specific aim:

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75219
        • Recruiting
        • Texas Scottish Rite Hospital for Children
        • Principal Investigator:
          • Anthony I Riccio, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical
Corrective Surgery only
Procedure: Surgical
Surgery only
Non-Surgical
Correction with casting, braces, Physical therapy, other non-surgical methods
Procedure: Non-Surgical
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
Procedure: Non-surgical + surgical
Combination of non-surgical methods subsequently followed by surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of correction at initial brace wear
Time Frame: 2 months
Dimeglio scoring system will be used (score range from 0-20)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Scottish Rite Hospital for Children

Investigators

  • Principal Investigator: Anthony I Riccio, MD, Texas Scottish Rite Hospital for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Anticipated)

September 1, 2029

Study Completion (Anticipated)

September 1, 2029

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 032011-131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be collected at one site, only results of data analysis will be release in publishing. Data itself will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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