Clinical trial NCT04058561: Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
Official title: Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early-Onset Scoliosis Deformity of Spine
Keywords: Spinal deformity, early onset scoliosis
Lead sponsor: Pediatric Spine Foundation
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2019-08-15
Enrollment: 210
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sites will be randomized into two arms of lengthening intervals: 6 weeks (+/- 2 weeks) or 16 weeks (+/- 2 weeks).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spinal growth
timeFrame: 3 years
Secondary outcomes:
measure: Complications
timeFrame: 3 years
measure: Curve correction
timeFrame: 3 years
measure: Health related quality of life: questionnaire
timeFrame: 3 years
measure: Burden of care
timeFrame: 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital - San Diego
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Alfred I. DuPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital, University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine, St. Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children - Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Campbell Clinic/Le Bonheur Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital
state: Texas
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Turku
country: Finland
facility: Turku University Hospital, Department of Pediatric Orthopaedic Surgery
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong, Department of Orthopaedics and Traumatology
Study officials:
affiliation: Columbia University
name: Michael Vitale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong, Department of Orthopaedics and Traumatology
name: Kenneth MC Cheung, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
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