Juvenile or adolescent idiopathic scoliosis Musculoskeletal Diseases
Conditions
Interventions
This multicentre, single-arm, prospective study will enrol 30 subjects in Canada, each of whom will have the MIScoli® system implanted. Subjects with a successfully implanted investigational device wi
Sponsors
Spino Modulation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Candidates for this study must meet ALL of the following criteria: 1. Diagnosis of juvenile or adolescent idiopathic scoliosis 2. Male or female subjects greater than 8 years of age with significant growth remaining 3. European Risser Stage 0 or 1 and Sanders score less than or equal to (=) 5, at Visit 1 4. Major scoliosis with Cobb angle > 40° and 30° with attempted but failed brace treatment. Failure of brace treatment is defined as greater than (>) 5° of progression and/or intolerance to brace wear 5. Thoracic kyphosis (T5-T12) < 50°. 6. Instrumentation to be applied no more cephalad than T4 and no more caudal than L4 (inclusive) 7. The subject must be physically and mentally willing and able to comply with the study visit schedule and all protocol requirements 8. Subject assent and parent/legal guardian consent obtained and documented
Exclusion criteria
Exclusion criteria: Candidates will be excluded from the study if ANY of the following apply: 1. The vertebrae to be instrumented are less than 12mm in height (based on the MIScoli® staple size) 2. One of the vertebrae to be instrumented in less than 20.5mm in width (based on the smallest MIScoli® screw length) 3. One of the vertebrae to be instrumented is more than 44mm in width (based on the longest MIScoli® screw length) 4. Diagnosis of non-idiopathic scoliosis 5. Menarche onset > 4 months at Visit 1 6. Non-ambulatory 7. Clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget’s disease or metabolic bone disease 8. Prior thoracic surgery for any reason 9. Abnormal neurological exam for any reason at Visit 1 10. Enrollment in an active drug or device trial that is more than minimal risk and where participation in the trial would confound the measurements for the present study 11. Enrollment in a device trial for the efficacy of a musculoskeletal device and where participation in the trial would confound the measurements for the present study 12. Less than 30 days from completion of another clinical trial of more than minimal risk or for assessment safety and efficacy 13. 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 |
|---|---|
| 1. Major Cobb angle measured using X-ray readings is less than or equal to 40° at Visit 8 / 24 months AND freedom from treatment-related SAE measured using medical records up to 24 months post-implantation 2. Rate of treatment-related SAE up to 24 months post-implantation 3. Major Cobb angle measured using X-ray readings of less than or equal to 40° at Visit 8 / 24 months postimplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of suspected tether breakage adverse events measured using medical records up to 6, 12, 18 and 24 months post-implantation 2. Health-Related Quality of Life (HRQoL) measured using the SRS-22r questionnaire at Visit 1 / Pre-op to each follow-up visit until Visit 8 / 24 months 3. Back pain measured using a Visual Analog Scale (VAS) at Visit 1 / Pre-op to each follow-up visit until Visit 8 / 24 months 4. Instrumented Cobb angle measured using X-ray readings of a change of 6° or more from Visit 4 / 6 weeks to each follow-up visit until Visit 8 / 24 months 5. Instrumented Cobb angle change measured using X-ray readings from Visit 4 / 6 weeks to each follow-up visit until Visit 8 / 24 months 6. Major Cobb angle measured using X-ray readings less than or equal to 40° at Visit 8 / 24 months post-implantation AND no revision surgery up to 12 months postimplantation AND up to one revision surgery between 12 months and 24 months postimplantation AND freedom from subsequent reoperation up to 24 months post-implantation. 7. Constant Cobb angle measured using X-ray readings less than or equal to 40° at Visit 8 / 24 months post-implantation AND no revision surgery up to 12 months postimplantation AND up to one revision surgery between 12 months and 24 months postimplantation AND freedom from subsequent reoperation up to 24 months post-implantation. 8. Instrumented Cobb angle measured using X-ray readings less than or equal to 40° at Visit 8 / 24 months post-implantation AND no revision surgery up to 12 months post-implantation AND up to one revision surgery between 12 months and 24 months post-implantation AND freedom from subsequent reoperation up to 24 months post-implantation. | — |
Countries
Canada
Contacts
Public ContactAgapi Bolanakis
Outcome results
None listed