Prospective Evaluation of Treatment for Clubfoot

Sponsor

Texas Scottish Rite Hospital for Children (Other)

Overall Status

Recruiting

CT.gov ID

NCT02257229

Collaborator

(none)

1,000

Enrollment

Location

289

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Specific aim:

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

Condition or Disease	Intervention/Treatment	Phase
Clubfoot Deformity	Procedure: Surgical Procedure: Non-Surgical Procedure: Non-surgical + surgical

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Evaluation of Treatment for Clubfoot

Study Start Date :

Aug 1, 2005

Anticipated Primary Completion Date :

Sep 1, 2029

Anticipated Study Completion Date :

Sep 1, 2029

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Degree of correction at initial brace wear [2 months]
Dimeglio scoring system will be used (score range from 0-20)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Scottish Rite Hospital for Children	Dallas	Texas	United States	75219

Sponsors and Collaborators

Texas Scottish Rite Hospital for Children

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anthony Riccio, Principal Investigator, Texas Scottish Rite Hospital for Children

ClinicalTrials.gov Identifier:

NCT02257229

Other Study ID Numbers:

032011-131

First Posted:

Oct 6, 2014

Last Update Posted:

May 4, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Anthony Riccio, Principal Investigator, Texas Scottish Rite Hospital for Children

Clubfoot, deformity, correction, management, gait

Additional relevant MeSH terms:

Congenital Abnormalities

Study Results

No Results Posted as of May 4, 2022