Trial Summary
What is the purpose of this trial?This study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and potential ways to mitigate the potential harms of treatment.
Eligibility Criteria
This trial is for boys and girls aged 9-16 with severe scoliosis needing spinal fusion surgery or brace treatment. A control group of similar age, gender, and BMI with healed forearm fractures will also participate to compare muscle function.Inclusion Criteria
I am a child with a healed forearm fracture, matched in age, gender, and BMI with the case patients.
I am between 9 and 16 years old.
I need surgery for my severe scoliosis.
+1 more
Exclusion Criteria
Patients with underlying muscle conditions or neuromuscular scoliosis
Participant Groups
The study examines how treatments like spinal fusion surgery and bracing affect muscle activity in young scoliosis patients using devices that measure movement (Tri-axial Accelerometers) and muscle stiffness (Shear Wave Elastography).
3Treatment groups
Experimental Treatment
Active Control
Group I: Control ArmExperimental Treatment2 Interventions
The control group are participants who do not have scoliosis. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified at baseline and one year after enrollment.
Group II: Brace TreatmentActive Control3 Interventions
The bracing participants have scoliosis curves that require treatment with a spinal brace for at least the next year. All braces will have monitors to record hours of brace wear, as is current standard of care. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before bracing and after one year.
Group III: Spinal Fusion SurgeryActive Control3 Interventions
The surgical participants recruited from the pediatric orthopaedic clinic and have severe scoliosis curves requiring posterior spinal fusion. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before and one year after spinal fusion surgery.
Spinal Fusion Surgery is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tymlos for:
- Osteoporosis in postmenopausal women at high risk of fracture
- Increase bone density in men with osteoporosis
🇪🇺 Approved in European Union as Eladynos for:
- Osteoporosis in postmenopausal women at increased risk of fracture
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
Loading ...
Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor