Status:
ACTIVE_NOT_RECRUITING
Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
Lead Sponsor:
Pediatric Spine Foundation
Collaborating Sponsors:
Columbia University
Conditions:
Early-Onset Scoliosis Deformity of Spine
Eligibility:
All Genders
5-9 years
Phase:
NA
Brief 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 majo...
Detailed Description
The Magnetically Controlled Growing Rod (MCGR) system consists of growing rods similarly implanted as with traditional approaches, but with subsequent noninvasive distractions. The implanted growing r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04058561
Start Date
November 1 2019
End Date
December 31 2027
Last Update
October 24 2024
Active Locations (20)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803