Current condition as of 27/10/2021: Major thoracic scoliosis with Cobb Angle greater than 40° and less than 70° and Lenke I, II or V curve pattern. Children/adolescents with curves greater than 30° with attempted but failed brace treatment are also potential candidates for this study. _____ Previous Condition: Major thoracic scoliosis with Cobb Angle greater than 40° and Lenke I, II and V curve pattern. Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 27/10/2021:
The MIScoli™ system is intended for anterolateral vertebral body fixation and internal fastening of the convex side of the thoracic curvatures thereby reducin
Sponsors
Spino Modulation Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/10/2021: 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 at Visit 1. 4. Subjects should have at least three years of estimated growth remaining based on European Risser staging. 5. Major thoracic scoliosis with Cobb angle > 40° and 40° and 40° and < 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace 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
Exclusion criteria: Current exclusion criteria as of 06/03/2020: 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 _____ Previous exclusion criteria: 1. The vertebrae to be instrumented is less than 12 mm in height (based on the staple size) 2. One of the vertebrae to be instrumented in less than 22 mm in width (base on smallest screw length) 3. One of the vertebrae to be instrumented in more than 44 mm in width (base on longest screw length) 4. Non-idiopathic scoliosis 5. Non-ambulatory 6. Clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget’s disease and metabolic bone disease 7. Prior thoracic surgery 8. Abnormal neurological status at baseline 9. 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 |
|---|---|
| Current primary outcome measure as of 27/10/2021: Benefit of MIScoli™ system in halting the progression of the major curve (Cobb angle) of scoliosis in growing subject measured by examination of x-rays at baseline and 3-year follow-up. The x-rays will be reviewed by an independent contract laboratory organization. _____ Previous primary outcome measure as of 25/01/2021: Benefit of SCOLI-TETHER System in halting the progression of the major curve (Cobb angle) of scoliosis in growing subject measured by examination of x-rays at baseline and 3-year follow-up. The x-rays will be reviewed by an independent contract laboratory organization. _____ Previous primary outcome measure: Benefit of SCOLI-TETHER System in halting the progression of the major curve (Cobb angle) of scoliosis in growing subject measured by examination of x-rays at baseline and 5-year follow-up. The x-rays will be reviewed by an independent contract laboratory organization | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/10/2021: Quality of life of the subjects that were treated with the MIScoli™ system measured using SRS-30 questionnaire at 3 year follow-up. _____ Previous secondary outcome measures as of 25/01/2021: Quality of life of the subjects that were treated with the SCOLI-TETHER System measured using SRS-30 questionnaire at 3 year follow-up _____ Previous secondary outcome measures: Quality of life of the subjects that were treated with the SCOLI-TETHER System measured using SRS-30 questionnaire at 5 year follow-up | — |
Countries
Canada
Outcome results
None listed