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Outcomes of Compliance With Brace Wear in Clubfoot

NCT ID: NCT01481324

Last Updated: 2014-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Clubfoot

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Functioning Pressure Sensor Group

This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.

No interventions assigned to this group

Non-Functioning Pressure Sensor Group

This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.

No interventions assigned to this group

No Sensor Group

This group will not have a pressure sensor placed on the foot ankle orthosis.

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kosair Charities, Inc.

OTHER

Sponsor Role collaborator

Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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Todd Milbrandt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Todd A Milbrandt, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children

Locations

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Shriners Hospital for Children

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17012432 (View on PubMed)

Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.

Reference Type BACKGROUND
PMID: 10934626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17332096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14711941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15718907 (View on PubMed)

Other Identifiers

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SHC-Lex-101

Identifier Type: -

Identifier Source: org_study_id