Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early-Onset Scoliosis Deformity of Spine
- Sponsor
- Pediatric Spine Foundation
- Enrollment
- 210
- Locations
- 20
- Primary Endpoint
- Spinal growth
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Spinal growth
Time Frame: 3 years
T1-S1 growth
Secondary Outcomes
- Health related quality of life: questionnaire(3 years)
- Curve correction(3 years)
- Complications(3 years)
- Burden of care(3 years)