Menu
Recruiting NCT07154550

Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

No phase Interventional Club Foot

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mastisol.
Who it may be relevant to
Registry conditions: Club Foot. Basic parameters: 0 Weeks — 12 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

Overview

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

  • Device Mastisol
    a liquid adhesive used to secure dressings for extended periods of time

Primary outcome measures

  • Number 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]
Secondary outcome measures (7)
  • 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 [Time frame: up to 12 weeks]
  • Incidence of Severe Adverse Events [Time frame: up to 12 weeks]
  • Incidence of formation of complex clubfoot [Time frame: up to 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UW-Health Pediatric Orthopedics Clinics — Madison

Identifiers

NCT: NCT07154550 · 2025-0724 · Protocol Version 1/8/2026 · SMPH/ORTHO&REHAB/ORTHO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗