A study to evaluate the performance of a pedicle screw system for correction and fusion of Adolescent Idiopathic Scoliosis

Not Applicable

• Conditions: Adolescent idiopathic scoliosis; Musculoskeletal - Other muscular and skeletal disorders; Surgery - Other surgery

• Registration Number: ACTRN12612000316808
• Lead Sponsor: Kspine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Subject has AIS with Lenke type 1A or 1B main thoracic curve
Cobb angle between 40 and 65 degrees
Curve must reduce to greater than or equal to 50 % on lateral bend x-ray
Subject does not have hyper-kyphotic thoras defined as greater than or equal to 50 degree angle on lateral x-ray
Sanders score 3 - 7

Exclusion Criteria

hyper-kyphotic thorax (greater than or equal to 50 degrees)
History of metabolic bone disease affecting bone structure
Previous spine surgery
Active infection
Pregnant or planning to become pregnant during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate device performance by assessing the magnitude of the main thoracic Cobb angle in the coronal view of an x-ray image at baseline and compare to that at 6 months post-index implantation x-ray image.[Baseline, 6 months];Device safety as freedom from serious device and/or procedural-related adverse events within 6 months post-index implantation. Possible adverse events are those that may currently happen with any deformity surgery of the thoracic region where a pedicle screw system is used. They may include but are not limited to: implant failure including malpositon, migration, bending and/or fracture, early or late loosening of the implanted system. These are all monitoring at the imlplant procedure and with imaging at various stages of the study.[Post-implant to 6 months]

Secondary Outcome Measures

Name	Time	Method
Assess the magnitude of the Cobb angle in the coronal view of a x-ray image at baseline and 12 and 24 months[12 and 24 months];Evaluate Quality of Life using the SRS 22r quesionnaire[baseline, 6 months, 12 months, 24 months];Evaluate device safety as freedom from serious device and/or procedure-related adverse events 12 and 24 months post index procedure. Possible adverse events are those that may currently happen with any deformity surgery of the thoracic region where a pedicle screw system is used. They may include but are not limited to: implant failure including malpositon, migration, bending and/or fracture, early or late loosening of the implanted system. These are all monitoring at the imlplant procedure and with imaging at various stages of the study.[12 and 24 months]