Active — Not RecruitingNot Applicable

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

United States210 participantsStarted 2019-11-01

Plain-language summary

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.

Who can participate

Age range5 Years – 9 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Spinal growth

Timeframe: 3 years

Trial details

NCT IDNCT04058561

SponsorPediatric Spine Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Early-Onset Scoliosis Deformity of Spine trials