Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period (NCT04992845) | Clinical Trial Compass
TerminatedNot Applicable
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
Stopped: The Sponsor decided to focus their resources on the clinical data collection for the second generation of the investigational device.
Canada44 participantsStarted 2019-04-15
Plain-language 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.
Who can participate
Age range9 Years – 18 Years
SexALL
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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
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)