Adolescent idiopathic scoliosis (AIS) Musculoskeletal Diseases Scoliosis
Conditions
Interventions
Force measurements will be taken to determine the force necessary to move a curved spine toward midline. The total duration of treatment for this study will be approximately 10 minutes. After these m
Sponsors
Kspine, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has idiopathic scoliosis with a single curve requiring surgical treatment via a posterior only surgical approach 2. The curve appears to be compliant as evidenced by standing bending x-rays and/or the ability of the surgeon to improve the curve with external manipulation 3. Patient must be between 8 and 16 years old, either sex
Exclusion criteria
Exclusion criteria: 1. Patient has an underlying neurologic or congenital pathology involving the spine in addition to idiopathic scoliosis 2. Patient has local or systemic infection 3. Patient is participating in any other device or drug study 4. Patient is grossly obese with a body mass index greater than 40 kg/m^2 5. Patient has a history of communicable disease such as human immunodeficiency virus (HIV), hepatitis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Force measurements to determine the force necessary to move a curved spine toward midline, measured near the beginning of the surgery and completed before the surgery to correct the patient?'s scoliosis is begun. | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of curve correction at a maximum of 40 lbs of force, measured near the beginning of the surgery and completed before the surgery to correct the patient?'s scoliosis is begun. | — |
Countries
United Kingdom
Outcome results
None listed