Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

Overview

About this study

The purpose of this study is to evaluate the continued safety and probable benefit of the MID-C system for 5 years post-implantation in Adolescent Idiopathic Scoliosis (AIS).

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:

  • Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves.
  • Cobb angle between 40-60 degrees (inclusive).
  • Flexible curve that that reduces to ≤ 30 degrees on lateral side bending radiographs or as evident by traction x-ray.
  • Kyphosis angles of ≤ 55 degrees measured from T5 to T12.
  • Appropriate candidate for posterior surgical approach.
  • Patient has good general health.
  • Patient has no known hypersensitivity or allergies to titanium.
  • Patient’s guardian signs a written informed consent form (ICF).

Exclusion Criteria:

  • Any type of non-idiopathic scoliosis.
  • Any main thoracic deformity that includes vertebral levels and cranial including to T2.
  • Known history of existing malignancy, or any systemic or local infection.
  • Spinal cord abnormalities that require treatment.
  • Known neurological deficit (defined as motor grade < 5/5).
  • Known poor bone quality defined as T score -1.5 or less.
  • For female patient, pregnancy.
  • Previous spine surgery.
  • Active systemic disease, such as AIDS, HIV, or active infection.
  • Active infection or the skin is compromised at the surgical site.
  • Systemic disease that would affect the Patient’s welfare or overall outcome of the study.

 

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:

Smitha Mathew M.B.B.S.

(507) 538-3560

Mathew.Smitha@mayo.edu

Minneapolis, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Open for enrollment

Contact information:

Smitha Mathew M.B.B.S.

(507) 538-3560

Mathew.Smitha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20490428

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