Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
Stopped early · Not applicable
Conditions studied: Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis
In brief
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
Key facts
- Study ID
- NCT04929678
- Run by
- Medtronic Spinal and Biologics
- People needed
- 10
- Starts
- 2021-08-12
- Expected to finish
- 2026-01-14
- Last updated by the study team
- 2026-03-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A subject must meet all of the following inclusion criteria to participate in this study:
- Has a diagnosis of juvenile or adolescent idiopathic scoliosis
- Is skeletally immature with a Sanders Score of ≥2 to ≤5
- Has failed conservative care as per investigator's assessment
- Has a main thoracic Cobb angle between 30 and 60 degrees
- Has a Lenke Classification of 1A, 1B, or 1C
- Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative
- Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by Parent/legal guardian and/or patient/participant per local requirement.
You may not qualify if…
- A subject will be excluded from participating in this study for any of the following reasons:
- Has undergone previous spinal fusion procedure(s) at the affected levels
- Is pregnant or plans to become pregnant within the first 24-months of the study
- Has a curve that requires instrumentation below L1
- Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord)
- Has any type of non-idiopathic scoliosis
- Has a left-sided curve
- Has an associated syndrome
- Has a history of malignant hyperthermia
- Has an active or significant risk of infection (immunocompromised)
- Has inadequate tissue coverage over the operative site as per investigator's assessment
- Has a suspected or documented allergy or intolerance to implant materials
- Has a major psychiatric disorder / history of drug abuse that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation as per investigator's assessment (DSM-5 can be used as a reference)
- Is a ward of the court/state
- Has had prior ipsilateral or contralateral chest surgery
- Has severe chronic lung disease (e.g., asthma, bronchiectasis)
- Has poor bone quality, as determined by the investigator, that may limit anterior fixation
- Is unwilling or unable to return for follow-up visits and/or follow intra-operative and/or postoperative instructions
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
- IWK Health Centre — Halifax, Nova Scotia, Canada
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
- The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom
Full record on ClinicalTrials.gov
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