Prospective Evaluation of Treatment for Clubfoot
Recruiting
- Conditions
- Clubfoot Deformity
- Interventions
- Procedure: Non-surgical + surgicalProcedure: Non-SurgicalProcedure: Surgical
- Registration Number
- NCT02257229
- Lead Sponsor
- Texas Scottish Rite Hospital for Children
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2500
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-surgical + surgical Non-surgical + surgical Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery Non-Surgical Non-Surgical Correction with casting, braces, Physical therapy, other non-surgical methods Surgical Surgical Corrective Surgery only
- Primary Outcome Measures
Name Time Method Degree of correction at initial brace wear 2 months Dimeglio scoring system will be used (score range from 0-20)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Texas Scottish Rite Hospital for Children
🇺🇸Dallas, Texas, United States