Adults 8 to 16, any sex, with Idiopathic Scoliosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Treatment-Emergent Adverse EventsPrimary· up to 2 years
Intra-operative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".
Subjects that experienced a device-related AE
Group
Value
95% CI
Anterior Vertebral Tethering
11
Subjects that experienced a device-related SAE
Group
Value
95% CI
Anterior Vertebral Tethering
7
Subjects that experienced a non-device related AE
Group
Value
95% CI
Anterior Vertebral Tethering
20
Subjects that experienced a non-device related SAE
Group
Value
95% CI
Anterior Vertebral Tethering
0
Comparison of Pre-Operative and Post-Operative Cobb AngleSecondary· up to 2 years
The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine.
Group
Value
95% CI
Anterior Vertebral Tethering
14
Anterior Vertebral Tethering
6
Comparison of Pre-Operative and Post-Operative SRS 30 ScoresSecondary· up to 2 years
The Scoliosis Research Society 30 (SRS-30) questionnaire will be administered at pre-operative and post-operative time points. This questionnaire measures health-related quality of life outcomes. It consists of 30 questions divided into five domains: Function/Activity (5 questions), Pain (5 questions), Self-image/Appearance (5 questions), Mental Health (5 questions), and Satisfaction with management (2 questions). The remaining 8 questions are a combination of different domains. Each question is scored on a 5-point scale (1 = worst, 5 = best). To score each domain, sum the scores of the questi
Pre-operative Function/Activity
Group
Value
95% CI
Anterior Vertebral Tethering
4.4
± 0.4
Pre-operative Pain
Group
Value
95% CI
Anterior Vertebral Tethering
4.3
± 0.7
Pre-operative Self-image/Appearance
Group
Value
95% CI
Anterior Vertebral Tethering
3.6
± 0.8
Pre-operative Mental Health
Group
Value
95% CI
Anterior Vertebral Tethering
4.2
± 0.6
Pre-operative Satisfaction with management
Group
Value
95% CI
Anterior Vertebral Tethering
3.5
± 0.9
Pre-operative total score
Group
Value
95% CI
Anterior Vertebral Tethering
4.1
± 0.5
Post-operative Function/Activity
Group
Value
95% CI
Anterior Vertebral Tethering
4.5
± 0.4
Post-operative Pain
Group
Value
95% CI
Anterior Vertebral Tethering
4.6
± 0.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will assess whether Anterior Vertebral Tethering is a safe and feasible method of anterior approach surgery for spinal deformity in pediatric idiopathic scoliosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Patrick Cahill, MD
Last refreshed: 23 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03194568.