Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis
Conditions
Brief summary
The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.
Interventions
The SCOLI-TETHER (MIScoli) System is intended for anterolateral vertebral body fixation and internal fastening of the convex side of the thoracic curvatures thereby reducing the deformity and preventing the progression of idiopathic scoliosis in growing children/adolescents at high risk for curve progression while preserving motion.
Sponsors
Spino Modulation Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of juvenile or adolescent idiopathic scoliosis 2. Male and female subjects greater than 8 years of age with significant growth remaining 3. Risser Stage 0 or 1 4. Subjects should have at least three years of estimated growth remaining based on Risser staging 5. Major thoracic scoliosis with Cobb Angle \> 40° and \< 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure 6. Thoracic kyphosis (T5-T12) \< 50° 7. Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive) 8. Menses \< 4 months 9. Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations 10. Subject assent and parent/legal guardian consent obtained and documented.
Exclusion criteria
1. Scoliosis curve is less than 30° or more than 70° 2. Thoracic kyphosis is greater than or equal to 50° (T5-T12) 3. The vertebrae to be instrumented is less than 12mm in height (based on the staple size) 4. One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length) 5. One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length) 6. Non-idiopathic scoliosis 7. Non-ambulatory 8. Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease 9. Prior thoracic surgery 10. Abnormal neurological status at baseline 11. Any condition or therapy that the investigator believes might pose a risk to the participant or make participation in the study not in the participant's best interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cobb angle measurement | 12 months | The change in Cobb angle measurement from baseline (preoperative) to 12 months |
| Rate of device- &/or procedure-related SAEs | 12 months | Rate of positively adjudicated device or procedure related serious adverse events including subsequent secondary surgical intervention and neurological events from baseline (preoperative) through 12 months |
Countries
Canada
Outcome results
None listed