Club Foot
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMastisol
a liquid adhesive used to secure dressings for extended periods of time
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
a single group of infant participants will have the intervention randomized to either their left or their right leg
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 12 Weeks
Healthy volunteers
No
Inclusion criteria
* Patients with bilateral clubfeet * Starting standard of care treatment with the Ponseti method between 0-12 weeks of age * For patients born pre-maturely their eligibility age will be based on a corrected gestational age * Patients for whom at least one parent/guardian is able to converse, read, and write in English
Exclusion criteria
* Patients who do not have bilateral clubfoot * Patients who are starting treatment for clubfoot after 12 weeks of age * Patients whose parents/guardians are unable to converse, read, and write in English * Patients whose parents/guardian do not provide or are not able to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Weeks Need to Obtain Correction | up to 12 weeks |
| Incidence of recurrent casting or tenotomy | follow up to 5 years from medical records |
| Incidence of reconstructive surgery | follow up to 5 years from medical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Casts to Correction | up to 12 weeks | — |
| Number of times that each leg has unplanned re-casting in between visits | up to 12 weeks | — |
| Tibio-calcaneal angle measured from radiograph at tenotomy time point | up to 12 weeks | — |
| Dorsiflexion angle measure from radiograph at tenotomy time point | up to 12 weeks | — |
| Incidence of Adverse Events | up to 12 weeks | sores, redness, swelling, irritation, obvious slippage |
| Incidence of Severe Adverse Events | up to 12 weeks | severe dermatitis |
| Incidence of formation of complex clubfoot | up to 12 weeks | — |
Countries
United States
Contacts
CONTACTAva Barker
PRINCIPAL_INVESTIGATORPatrick Touhy, MD
UW School of Medicine and Public Health
PRINCIPAL_INVESTIGATORKenneth Noonan, MD
UW School of Medicine and Public Health
Outcome results
None listed