Health TrialsbyHealthPanel

Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

ConditionClub Foot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-12
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mastisol

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Leg with MastisolExperimental treatment 1 intervention
Group B: Control LegNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of Weeks Need to Obtain Correction

Time frame
up to 12 weeks
2

Incidence of recurrent casting or tenotomy

Time frame
follow up to 5 years from medical records
3

Incidence of reconstructive surgery

Time frame
follow up to 5 years from medical records

Secondary outcomes

1

Number of Casts to Correction

Time frame
up to 12 weeks
2

Number of times that each leg has unplanned re-casting in between visits

Time frame
up to 12 weeks
3

Tibio-calcaneal angle measured from radiograph at tenotomy time point

Time frame
up to 12 weeks
4

Dorsiflexion angle measure from radiograph at tenotomy time point

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov
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