Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
- Conditions
- Early-Onset Scoliosis Deformity of Spine
- Registration Number
- NCT04058561
- Lead Sponsor
- Pediatric Spine Foundation
- 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 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.
- 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 rods are magnetically controlled and adjusted outside the body using an external remote controller (ERC) following initial surgical insertion. No incision or anesthesia are used for rod lengthening procedures and they are performed by the surgeon in an outpatient or office setting. The purpose of this study is to determine the effect of a 6-week lengthening interval compared to a 16-week lengthening interval on spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age with a major coronal curve over 50 degrees undergoing MCGR treatment within 3 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Spinal growth 3 years T1-S1 growth
- Secondary Outcome Measures
Name Time Method Health related quality of life: questionnaire 3 years Early onset scoliosis 24 item questionnaire; This is a patient reported outcome measure for quality of life, parental/financial burden, and satisfaction (4 main domains). There are 11 sub-domains: General health, pain/discomfort, pulmonary function, transfer, physical function, daily living, fatigue/energy level, emotion, parental impact, financial impact, and satisfaction. Within satisfaction, there is child and parent satisfaction. The raw score for each item is from 1-5. This can be turned into scale scores of 0-100. The higher values represent a better outcome. Average sub-domain scores as well as domain scores can be calculated.
Curve correction 3 years Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years
Complications 3 years Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other
Burden of care 3 years Early onset scoliosis 24 item questionnaire;This is a patient reported outcome measure for quality of life, parental/financial burden, and satisfaction (4 main domains). There are 11 sub-domains: General health, pain/discomfort, pulmonary function, transfer, physical function, daily living, fatigue/energy level, emotion, parental impact, financial impact, and satisfaction. Within satisfaction, there is child and parent satisfaction. The raw score for each item is from 1-5. This can be turned into scale scores of 0-100. The higher values represent a better outcome. Average sub-domain scores as well as domain scores can be calculated.
Trial Locations
- Locations (20)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Health System
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
C.S. Mott Children's Hospital, University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine, St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Scroll for more (10 remaining)Children's Hospital Los Angeles🇺🇸Los Angeles, California, United States