Evaluating treatments for clubfoot in infants
Prospective Evaluation of Treatment for Clubfoot
This study tests two different nonsurgical treatments for infants with clubfoot to see which one helps them the most.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Texas Scottish Rite Hospital for Children Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT02257229 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the outcomes of infants diagnosed with clubfoot deformity who undergo one of two nonsurgical treatment interventions. The research will establish a protocol for collecting clinical and functional outcome measures to enhance understanding and management of clubfoot. By focusing on both surgical and non-surgical approaches, the study seeks to provide valuable insights for orthopedic surgeons in treating this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are infants diagnosed with clubfoot deformity, particularly those who are Spanish speaking.
Not a fit: Patients without a diagnosis of clubfoot will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for infants with clubfoot, enhancing their functional outcomes.
How similar studies have performed: Other studies have shown success with similar nonsurgical approaches to treating clubfoot, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Texas Scottish Rite Hospital for Children — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Anthony I Riccio, MD — Texas Scottish Rite Hospital for Children
- Study coordinator: Rusty Hartman, MS
- Email: rusty.hartman@tsrh.org
- Phone: 214-559-8371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.