Prospective Evaluation of Treatment for Clubfoot | NCT02257229

Studies
Prospective Evaluation of Treatment for Clubfoot

NCT02257229

Sponsor

Texas Scottish Rite Hospital for Children

Status

Recruiting

Last Update Posted

May 4, 2025Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Clubfoot Deformity

Interventions

Surgical
Non-Surgical
Non-surgical + surgical

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Sep 2029Estimated

Completion Date

Sep 2029Estimated

First Submitted Date

Sep 22, 2014

First Submission Date that Met QC Criteria

Oct 1, 2014

First Posted Date

Oct 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2025

Last Update Posted Date

May 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Texas Scottish Rite Hospital for ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Specific aim:

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Surgical	Corrective Surgery only	Procedure: Surgical
Non-Surgical	Correction with casting, braces, Physical therapy, other non-surgical methods	Procedure: Non-Surgical
Non-surgical + surgical	Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery	Procedure: Non-surgical + surgical

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical	Procedure	Surgery only	Surgical
Non-Surgical

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rusty Hartman, MS	Contact	214-559-8371		rusty.hartman@tsrh.org
Jessica L Phillips, MPH	Contact	12145598562		jessica.laureano-phillips@tsrh.org

Overall Officials

Name	Affiliation	Role
Anthony I Riccio, MD	Texas Scottish Rite Hospital for Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Scottish Rite Hospital for Children	Recruiting	Dallas	Texas	75219	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003025	Clubfoot
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided