The purpose of this study is to assess if the application of Mastisol, a liquid adhesive, improves outcomes during bilateral clubfoot casting and reduces complications and development of complex clubfoot for the duration of their casting and up to 5 years follow-up.
Study Objectives include: * Determine if application of Mastisol is associated with improved clubfoot outcomes including length of treatment, recurrence of clubfoot, and reconstruction of clubfoot. * Assess if the application of Mastisol prior to cast placement is associated with reduced cast slippage and other complications such as severe skin irritation, sores, and development of complex clubfoot. The investigators hypothesize that Mastisol application will be associated with improved outcomes by helping to maintain a well-fitting cast, which can be key to reducing complications, optimizing correction (i.e. minimizing treatment time). Proper correction can ultimately be associated with decreased incidence of clubfoot recurrence and need for reconstruction. Participants' participation will last roughly 8-12 weeks but may be shorter or longer depending on their response to manipulation and casting. This is a standard expectation with the Ponseti method of clubfoot casting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
a liquid adhesive used to secure dressings for extended periods of time
UW-Health Pediatric Orthopedics Clinics
Madison, Wisconsin, United States
RECRUITINGNumber of Weeks Need to Obtain Correction
Time frame: up to 12 weeks
Incidence of recurrent casting or tenotomy
Time frame: follow up to 5 years from medical records
Incidence of reconstructive surgery
Time frame: follow up to 5 years from medical records
Number of Casts to Correction
Time frame: up to 12 weeks
Number of times that each leg has unplanned re-casting in between visits
Time frame: up to 12 weeks
Tibio-calcaneal angle measured from radiograph at tenotomy time point
Time frame: up to 12 weeks
Dorsiflexion angle measure from radiograph at tenotomy time point
Time frame: up to 12 weeks
Incidence of Adverse Events
sores, redness, swelling, irritation, obvious slippage
Time frame: up to 12 weeks
Incidence of Severe Adverse Events
severe dermatitis
Time frame: up to 12 weeks
Incidence of formation of complex clubfoot
Time frame: up to 12 weeks
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