The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.
Study Type
OBSERVATIONAL
Enrollment
54
University of Cairo Public Hospital
Cairo, Egypt
University of Helsinki
Helsinki, Finland
Turku University Hospital
Turku, Finland
Change in Cobb Angle
Measured in Degrees
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Thoracic Spine Height
Measured in millimeters (mm)
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Space Available for Lung
Measured as a percentage (%)
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Ocurrence of Procedure-Related Complications
Time frame: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Adverse Events
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Coronal Balance
Measured in millimeters (mm)
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Sagittal Balance
Measured in millimeters (mm)
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Subsequent surgical interventions following initial implantation
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Weight
Measured in kilograms (kg)
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Hong Kong
Hong Kong, Hong Kong
Instituto Rizzoli
Bologna, Italy
Bambin Gesu
Rome, Italy
Starship Children's Hospital
Auckland, New Zealand
Ankara Gazi Universitesi Hastanesi
Ankara, Turkey (Türkiye)
Hacettepe University Hospital
Ankara, Turkey (Türkiye)
Florence Nightingale Hospital Ortopedi Bolumu
Istanbul, Turkey (Türkiye)
...and 5 more locations