Comparing Outcomes and Complications Following Mastisol Application for Clubfoot Casting

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Number of Weeks Need to Obtain Correction [Срок оценки: up to 12 weeks]
• Incidence of recurrent casting or tenotomy [Срок оценки: follow up to 5 years from medical records]
• Incidence of reconstructive surgery [Срок оценки: follow up to 5 years from medical records]

Вторичные конечные точки (7)

• Number of Casts to Correction [Срок оценки: up to 12 weeks]
• Number of times that each leg has unplanned re-casting in between visits [Срок оценки: up to 12 weeks]
• Tibio-calcaneal angle measured from radiograph at tenotomy time point [Срок оценки: up to 12 weeks]
• Dorsiflexion angle measure from radiograph at tenotomy time point [Срок оценки: up to 12 weeks]
• Incidence of Adverse Events [Срок оценки: up to 12 weeks]
• Incidence of Severe Adverse Events [Срок оценки: up to 12 weeks]
• Incidence of formation of complex clubfoot [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UW-Health Pediatric Orthopedics Clinics — Madison

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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