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Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals

Early-Onset Scoliosis Deformity of Spine

A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    5 to 9

Participation Criteria

Inclusion Criteria:

* All patients with diagnosis of Early Onset Scoliosis (scoliosis before age 10)
* Between 5 and 9 years of age (5.0 to 9.9 years)
* Major curve greater than 50 degrees at time of index surgery
* Dual-rod Magnetically Controlled Growing Rod implantation only
* Spine or rib-based constructs
* Pre-operative and intra-operative halo gravity traction is allowed

Exclusion Criteria:

* Patients with previous spine surgery, including other growth friendly techniques
* Patients who cannot abide by the study requirements due to geographical or other similar constraints

Study Location

IWK Health Centre
IWK Health Centre
Halifax, Nova Scotia
Canada

Contact Study Team

Study Sponsored By
Pediatric Spine Foundation
Participants Required
More Information
Study ID: NCT04058561