Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (BRAIVE IDE)

Overview

About this study

The primary objective of this study is to demonstrate that the mean change in pre-operative main thoracic Cobb angle, compared to post-oprative Cobb angle at 24 months, is signifianty greater than 0.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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*.
  • Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study.

*Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study. 

Eligibility last updated 11/16/21. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Open for enrollment

Contact information:

Orthopedic Research Clinical Unit

(507) 266-6402

ORCU@mayo.edu

Minneapolis, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Contact us for the latest status

Contact information:

Natalie Pulido

(507) 538-3560

Pulido.Natalie@mayo.edu

More information

Publications

Publications are currently not available
.

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