Clubfoot DeformityNCT02257229
Prospective Evaluation of Treatment for Clubfoot
An observational study of Clubfoot Deformity, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
Trial summary
Specific aim: To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Clubfoot Deformity
- What is being tested?
- Surgical, Non-Surgical and Non-surgical + surgical
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Primary care clinic
Who may be able to join
- Patients with a diagnosis of clubfoot deformity
- Spanish speaking patients will be eligible to participate in the study.
Who cannot join
- All patients without a diagnosis of clubfoot
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219
Rusty Hartman, MS, 214-559-8371, rusty.hartman@tsrh.org
Anthony I Riccio, MD
About this study
Specific aim:
To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions
Read the 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.
- Conditions
- Clubfoot Deformity
- Being tested
- Surgical, Non-Surgical, Non-surgical + surgical
- Keywords
- Clubfoot, deformity, correction, management, gait
- Medical subject headings
- Clubfoot, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgicalProcedure or surgery
Surgery only
Non-SurgicalProcedure or surgery
non-surgical methods such as, casting, bracing, physical therapy, and other.
Non-surgical + surgicalProcedure or surgery
Combination of non-surgical methods subsequently followed by surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Corrective Surgery only Receives: Procedure: Surgical | |
| Non-Surgical | Correction with casting, braces, Physical therapy, other non-surgical methods Receives: Procedure: Non-Surgical | |
| Non-surgical + surgical | Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery Receives: Procedure: Non-surgical + surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of correction at initial brace wear
Dimeglio scoring system will be used (score range from 0-20)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startAug 2005
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clubfoot DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Riccio, Texas Scottish Rite Hospital for Children
- Investigators
- Anthony I Riccio, MD, Principal investigator, Texas Scottish Rite Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257229
- Sponsor's protocol ID
- 032011-131
- Status last verified
- Apr 2025
- First submitted
- 22 Sep 2014
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected at one site, only results of data analysis will be release in publishing. Data itself will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Treatment for Clubfoot
- ClinicalTrials.gov ID
- NCT02257229
- Acronym / sponsor ID
- 032011-131
- Conditions
- Clubfoot Deformity
- Keywords
- Clubfoot, deformity, correction, management, gait
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | Procedure: SurgicalCorrective Surgery only |
| Non-Surgical | – | Procedure: Non-SurgicalCorrection with casting, braces, Physical therapy, other non-surgical methods |
| Non-surgical + surgical | – | Procedure: Non-surgical + surgicalCorrection with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Patients with a diagnosis of clubfoot deformity
- Spanish speaking patients will be eligible to participate in the study.
Key exclusion criteria (1 listed)
- All patients without a diagnosis of clubfoot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgicalSurgery only | Procedure or surgery | Surgical |
| Non-Surgicalnon-surgical methods such as, casting, bracing, physical therapy, and other. | Procedure or surgery | Non-Surgical |
| Non-surgical + surgicalCombination of non-surgical methods subsequently followed by surgery | Procedure or surgery | Non-surgical + surgical |
Primary outcome
Degree of correction at initial brace wear
Time frame: 2 months
Dimeglio scoring system will be used (score range from 0-20)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No. Data will be collected at one site, only results of data analysis will be release in publishing. Data itself will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony I Riccio, MD principal investigator
Texas Scottish Rite Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot Deformity, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rusty Hartman, MS (214-559-8371, rusty.hartman@tsrh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of correction at initial brace wear (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.