Early-Onset Scoliosis Deformity of SpineMCGRNCT04058561
Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
A study testing MAGEC® Spinal Bracing And Distraction System in people with Early-Onset Scoliosis Deformity of Spine, run by Pediatric Spine Foundation at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Early-Onset Scoliosis Deformity of Spine
- What is being tested?
- MAGEC® Spinal Bracing And Distraction System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 1 Nov 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States17 sites
C.S. Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, 48109-4241
Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Medical University of South Carolina
Charleston, South Carolina, 29425
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Texas Scottish Rite Hospital
Dallas, Texas, 75219
University of Florida
Gainesville, Florida, 32611
Children's Hospital Los Angeles
Los Angeles, California, 90027
Campbell Clinic/Le Bonheur Children's Hospital
Memphis, Tennessee, 38104
Columbia University Medical Center
New York, New York, 10032
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Shriners Hospitals for Children - Philadelphia
Philadelphia, Pennsylvania, 19140
Rady Children's Hospital - San Diego
San Diego, California, 92123
Washington University School of Medicine, St. Louis Children's Hospital
St Louis, Missouri, 63110
Children's National Health System
Washington D.C., District of Columbia, 20010
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803
Finland1 site
Turku University Hospital, Department of Pediatric Orthopaedic Surgery
Turku, 20521
Hong Kong1 site
The University of Hong Kong, Department of Orthopaedics and Traumatology
Hong Kong
About this study
Official title: Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals
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.
Read the 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.
- Conditions
- Early-Onset Scoliosis Deformity of Spine
- Being tested
- MAGEC® Spinal Bracing And Distraction System
- Keywords
- Spinal deformity, early onset scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGEC® Spinal Bracing And Distraction SystemDevice
The magnetically controlled growth rod (MCGR) system is a remotely distractible, magnetically controlled growing rod. The remote capabilities allow for less invasive and less time-consuming outpatient distraction visits, which solves many of the problems facing current growing rod technologies. The MCGR system allows for more frequent lengthenings, and the implanted growing rods can be lengthened more often, which allows MCGR to better approximate normal spine growth compared to Traditional Growing Rods.
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks | Experimental | 6-week lengthening interval Receives: Device: MAGEC® Spinal Bracing And Distraction System |
| 16 weeks | Active comparator | 16-week lengthening interval Receives: Device: MAGEC® Spinal Bracing And Distraction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal growth
T1-S1 growth
Measured: 3 years
Secondary outcomes (4)
Complications
Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other
Measured: 3 years
Curve correction
Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years
Measured: 3 years
Health related quality of life: questionnaire
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.
Measured: 3 years
Burden of care
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Nov 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Early-Onset Scoliosis Deformity of SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sites will be randomized into two arms of lengthening intervals: 6 weeks (+/- 2 weeks) or 16 weeks (+/- 2 weeks).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Spine Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Michael Vitale, MD, Principal investigator, Columbia UniversityKenneth MC Cheung, MD, FRCS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058561
- Sponsor's protocol ID
- PSSG0038
- Acronym
- MCGR
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Corona J, Miller DJ, Downs J, Akbarnia BA, Betz RR, Blakemore LC, Campbell RM Jr, Flynn JM, Johnston CE, McCarthy RE, Roye DP Jr, Skaggs DL, Smith JT, Snyder BD, Sponseller PD, Sturm PF, Thompson GH, Yazici M, Vitale MG. Evaluating the extent of clinical uncertainty among treatment options for patients with early-onset scoliosis. J Bone Joint Surg Am. 2013 May 15;95(10):e67. doi: 10.2106/JBJS.K.00805.
PubMed 23677368Flynn JM, Matsumoto H, Torres F, Ramirez N, Vitale MG. Psychological dysfunction in children who require repetitive surgery for early onset scoliosis. J Pediatr Orthop. 2012 Sep;32(6):594-9. doi: 10.1097/BPO.0b013e31826028ea.
PubMed 22892621JAMES JI. Idiopathic scoliosis; the prognosis, diagnosis, and operative indications related to curve patterns and the age at onset. J Bone Joint Surg Br. 1954 Feb;36-B(1):36-49. doi: 10.1302/0301-620X.36B1.36. No abstract available.
PubMed 13130619Pehrsson K, Larsson S, Oden A, Nachemson A. Long-term follow-up of patients with untreated scoliosis. A study of mortality, causes of death, and symptoms. Spine (Phila Pa 1976). 1992 Sep;17(9):1091-6. doi: 10.1097/00007632-199209000-00014.
PubMed 1411763Smith JT. The use of growth-sparing instrumentation in pediatric spinal deformity. Orthop Clin North Am. 2007 Oct;38(4):547-52, vii. doi: 10.1016/j.ocl.2007.03.009.
PubMed 17945134Cheung KM, Cheung JP, Samartzis D, Mak KC, Wong YW, Cheung WY, Akbarnia BA, Luk KD. Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet. 2012 May 26;379(9830):1967-74. doi: 10.1016/S0140-6736(12)60112-3. Epub 2012 Apr 19.
PubMed 22520264Goldberg CJ, Gillic I, Connaughton O, Moore DP, Fogarty EE, Canny GJ, Dowling FE. Respiratory function and cosmesis at maturity in infantile-onset scoliosis. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2397-406. doi: 10.1097/01.BRS.0000085367.24266.CA.
PubMed 14560091Thompson GH, Akbarnia BA, Campbell RM Jr. Growing rod techniques in early-onset scoliosis. J Pediatr Orthop. 2007 Apr-May;27(3):354-61. doi: 10.1097/BPO.0b013e3180333eea.
PubMed 17414025Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H, Boachie-Adjei O, Karlin LI, Canale S, Poe-Kochert C, Skaggs DL. Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am. 2010 Nov 3;92(15):2533-43. doi: 10.2106/JBJS.I.01471. Epub 2010 Oct 1.
PubMed 20889912Caldas JC, Pais-Ribeiro JL, Carneiro SR. General anesthesia, surgery and hospitalization in children and their effects upon cognitive, academic, emotional and sociobehavioral development - a review. Paediatr Anaesth. 2004 Nov;14(11):910-5. doi: 10.1111/j.1460-9592.2004.01350.x.
PubMed 15500489Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
PubMed 8953995Akbarnia BA, Breakwell LM, Marks DS, McCarthy RE, Thompson AG, Canale SK, Kostial PN, Tambe A, Asher MA; Growing Spine Study Group. Dual growing rod technique followed for three to eleven years until final fusion: the effect of frequency of lengthening. Spine (Phila Pa 1976). 2008 Apr 20;33(9):984-90. doi: 10.1097/BRS.0b013e31816c8b4e.
PubMed 18427320Feinberg N, Matsumoto H, Hung CW, St Hilaire T, Pawelek J, Sawyer JR, Akbarnia BA, Skaggs DL, Roye BD, Roye DP Jr, Vitale MG. Expert Consensus and Equipoise: Planning a Randomized Controlled Trial of Magnetically Controlled Growing Rods. Spine Deform. 2018 May-Jun;6(3):303-307. doi: 10.1016/j.jspd.2017.11.002.
PubMed 29735141
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals
- ClinicalTrials.gov ID
- NCT04058561
- Acronym / sponsor ID
- MCGR / PSSG0038
- Conditions
- Early-Onset Scoliosis Deformity of Spine
- Keywords
- Spinal deformity, early onset scoliosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Pediatric Spine FoundationUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sites will be randomized into two arms of lengthening intervals: 6 weeks (+/- 2 weeks) or 16 weeks (+/- 2 weeks).
| Arm | Type | Receives |
|---|---|---|
| 6 weeks | Experimental | Device: MAGEC® Spinal Bracing And Distraction System6-week lengthening interval |
| 16 weeks | Active comparator | Device: MAGEC® Spinal Bracing And Distraction System16-week lengthening interval |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAGEC® Spinal Bracing And Distraction SystemThe magnetically controlled growth rod (MCGR) system is a remotely distractible, magnetically controlled growing rod. The remote capabilities allow for less invasive and less time-consuming outpatient distraction visits, which solves many of the problems facing current growing rod technologies. The MCGR system allows for more frequent lengthenings, and the implanted growing rods can be lengthened more often, which allows MCGR to better approximate normal spine growth compared to Traditional Growing Rods. | Device | 16 weeks, 6 weeks |
Primary outcome
Spinal growth
Time frame: 3 years
T1-S1 growth
4 secondary outcomes
Complications
Time frame: 3 years
Curve correction
Time frame: 3 years
Health related quality of life: questionnaire
Time frame: 3 years
Burden of care
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 23677368Corona J, Miller DJ, Downs J, Akbarnia BA, Betz RR, Blakemore LC, Campbell RM Jr, Flynn JM, Johnston CE, McCarthy RE, Roye DP Jr, Skaggs DL, Smith JT, Snyder BD, Sponseller PD, Sturm PF, Thompson GH, Yazici M, Vitale MG. Evaluating the extent of clinical uncertainty among treatment options for patients with early-onset scoliosis. J Bone Joint Surg Am. 2013 May 15;95(10):e67. doi: 10.2106/JBJS.K.00805.
- Background: PubMed 22892621Flynn JM, Matsumoto H, Torres F, Ramirez N, Vitale MG. Psychological dysfunction in children who require repetitive surgery for early onset scoliosis. J Pediatr Orthop. 2012 Sep;32(6):594-9. doi: 10.1097/BPO.0b013e31826028ea.
- Background: PubMed 13130619JAMES JI. Idiopathic scoliosis; the prognosis, diagnosis, and operative indications related to curve patterns and the age at onset. J Bone Joint Surg Br. 1954 Feb;36-B(1):36-49. doi: 10.1302/0301-620X.36B1.36. No abstract available.
- Background: PubMed 1411763Pehrsson K, Larsson S, Oden A, Nachemson A. Long-term follow-up of patients with untreated scoliosis. A study of mortality, causes of death, and symptoms. Spine (Phila Pa 1976). 1992 Sep;17(9):1091-6. doi: 10.1097/00007632-199209000-00014.
- Background: PubMed 17945134Smith JT. The use of growth-sparing instrumentation in pediatric spinal deformity. Orthop Clin North Am. 2007 Oct;38(4):547-52, vii. doi: 10.1016/j.ocl.2007.03.009.
- Background: PubMed 22520264Cheung KM, Cheung JP, Samartzis D, Mak KC, Wong YW, Cheung WY, Akbarnia BA, Luk KD. Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet. 2012 May 26;379(9830):1967-74. doi: 10.1016/S0140-6736(12)60112-3. Epub 2012 Apr 19.
- Background: PubMed 14560091Goldberg CJ, Gillic I, Connaughton O, Moore DP, Fogarty EE, Canny GJ, Dowling FE. Respiratory function and cosmesis at maturity in infantile-onset scoliosis. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2397-406. doi: 10.1097/01.BRS.0000085367.24266.CA.
- Background: PubMed 17414025Thompson GH, Akbarnia BA, Campbell RM Jr. Growing rod techniques in early-onset scoliosis. J Pediatr Orthop. 2007 Apr-May;27(3):354-61. doi: 10.1097/BPO.0b013e3180333eea.
- Background: PubMed 20889912Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H, Boachie-Adjei O, Karlin LI, Canale S, Poe-Kochert C, Skaggs DL. Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am. 2010 Nov 3;92(15):2533-43. doi: 10.2106/JBJS.I.01471. Epub 2010 Oct 1.
- Background: PubMed 15500489Caldas JC, Pais-Ribeiro JL, Carneiro SR. General anesthesia, surgery and hospitalization in children and their effects upon cognitive, academic, emotional and sociobehavioral development - a review. Paediatr Anaesth. 2004 Nov;14(11):910-5. doi: 10.1111/j.1460-9592.2004.01350.x.
- Background: PubMed 8953995Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
- Background: PubMed 18427320Akbarnia BA, Breakwell LM, Marks DS, McCarthy RE, Thompson AG, Canale SK, Kostial PN, Tambe A, Asher MA; Growing Spine Study Group. Dual growing rod technique followed for three to eleven years until final fusion: the effect of frequency of lengthening. Spine (Phila Pa 1976). 2008 Apr 20;33(9):984-90. doi: 10.1097/BRS.0b013e31816c8b4e.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Vitale, MD principal investigator
Columbia University
Kenneth MC Cheung, MD, FRCS principal investigator
The University of Hong Kong
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGEC® Spinal Bracing And Distraction System in people with Early-Onset Scoliosis Deformity of Spine, run by Pediatric Spine Foundation at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, Finland, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal growth (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058561, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.