N/A
N=67
Outcomes of Compliance With Brace Wear in Clubfoot
Clubfoot
Bottom Line
View on ClinicalTrials.gov: NCT01481324 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) — 91.7; NA; NA; 86.8 percentage of time worn
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- Shriners Hospitals for Children
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) |
91.7; NA; NA; 86.8; NA; NA | — |
Summary
It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. These studies have depended on family logs and not objective data. With the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes.
Hypothesis:
Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.
Eligibility Criteria
Inclusion Criteria
- Unilateral or bilateral clubfoot
- Birth to 3 years of age
- Has been successfully treated with Ponseti casting protocol
Exclusion Criteria
- Any other prior treatment for clubfoot
- Other existing diagnoses or conditions
Data sourced from ClinicalTrials.gov (NCT01481324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.