Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

University of Wisconsin (UW)

Status

Enrolling

Conditions

Club Foot

Treatments

Device: Mastisol

Study type

Interventional

Funder types

Other

Identifiers

NCT07154550

2025-0724

SMPH/ORTHO&REHAB/ORTHO (Other Identifier)

Protocol Version 1/8/2026 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

Under 12 weeks old

Volunteers

No Healthy Volunteers

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