200
Participants
Start Date
November 30, 2015
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2026
Spinal Fusion Surgery
Participants with severe scoliosis curves requiring spinal fusion surgery.
Bracing
Participants with scoliosis curves that require brace treatment for at least the next year. Braces include monitors to record hours of brace wear, as is current standard of care.
Tri-axial Accelerometers
Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.
Shear Wave Elastography (SWUE)
SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.
Mayo Clinic in Rochester, Rochester
Lead Sponsor
Mayo Clinic
OTHER