The purpose of this prospective, multi-center, longitudinal study is to assess clinical outcomes related to the surgical treatment of PRS ( Pierre Robin Sequence) by MDO (Mandibular distraction osteogenesis). This study aims to develop a scoring system to determine success and complication rate pre and post MDO.
The recruitment phase of this trial is 3 years. Duration of the trial is 19 years. All study patients who undergo mandibular distraction will be indicated for surgery following published and accepted protocols of care for mandibular distraction in this specific patient population. There will be no experimental/treatment arms in this study. All patients will undergo standard of care interventions and assessments that would not change if the patient were not to participate in this study. The purpose of this study is to follow multiple surgical outcomes following these standard of care practices. The methods and procedures detailed below follow published and accepted standards of care.
Study Type
OBSERVATIONAL
NYU School of Medicine
New York, New York, United States
Development of Functionality over time
We will monitor changes in maxillofacial development, functionality and surgical complications
Time frame: Q 6 years
Cleft Palate Repair outcome
Incidence of airway complications, Incidence of fistula and fistula location
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.