Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

Study Overview
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Brief Summary
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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.

Official Title
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Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

Conditions
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Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis

Intervention / Treatment
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* Device: Anterior Vertebral Body Tethering


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of juvenile or adolescent idiopathic scoliosis Male and female subjects greater than 8 years of age with significant growth remaining Risser Stage 0 or 1 Subjects should have at least three years of estimated growth remaining based on Risser staging 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 Thoracic kyphosis (T5-T12) < 50° Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive) Menses < 4 months Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations Subject assent and parent/legal guardian consent obtained and documented. Exclusion Criteria: Scoliosis curve is less than 30° or more than 70° Thoracic kyphosis is greater than or equal to 50° (T5-T12) The vertebrae to be instrumented is less than 12mm in height (based on the staple size) One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length) One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length) Non-idiopathic scoliosis Non-ambulatory Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease Prior thoracic surgery Abnormal neurological status at baseline 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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Vertebral Body Tethering surgery | Device: Anterior Vertebral Body Tethering<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device- &/or procedure-related SAEs | 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 | 12 months | 
| Change in Cobb angle measurement | The change in Cobb angle measurement from baseline (preoperative) to 12 months | 12 months |