Clinical trial NCT01481324: Outcomes of Compliance With Brace Wear in Clubfoot
Official title: Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clubfoot
Keywords: Clubfoot
Compliance
Brace wear
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: Kosair Charities, Inc.
First posted: 2011-11-29
Enrollment: 67
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All clubfoot patients scheduled to be placed in a foot ankle orthosis (FAO)

Brief 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.

Detailed description: It is necessary that treatment teams avoid making any assumptions about patient compliance. This study will objectively measure brace wear-rate in patients with clubfoot that have already been prescribed a foot ankle orthosis. The use of a monitoring device will be able to give objective data on actual patient compliance with brace wear. It is hypothesized that objective compliance data will allow physicians to better assess the patient's therapy progress and outcome, troubleshoot problems or issues associated with barriers to brace wear, and better educate families confronted with having a child with clubfoot. Long term goals will then attempt to determine whether certain brace designs can increase wear time thus decreasing the rate of clubfoot recurrence.

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

Primary outcomes:
measure: Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Shriners Hospital for Children
state: Kentucky
Study officials:
affiliation: Shriners Hospital for Children
name: Todd A Milbrandt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Changulani M, Garg NK, Rajagopal TS, Bass A, Nayagam SN, Sampath J, Bruce CE. Treatment of idiopathic club foot using the Ponseti method. Initial experience. J Bone Joint Surg Br. 2006 Oct;88(10):1385-7. doi: 10.1302/0301-620X.88B10.17578.
citation: Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.
citation: Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. doi: 10.2106/JBJS.F.00169.
citation: Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. doi: 10.2106/00004623-200401000-00005.
citation: Thacker MM, Scher DM, Sala DA, van Bosse HJ, Feldman DS, Lehman WB. Use of the foot abduction orthosis following Ponseti casts: is it essential? J Pediatr Orthop. 2005 Mar-Apr;25(2):225-8. doi: 10.1097/01.bpo.0000150814.56790.f9.