A Study to Create a Registry of Non-Fusion Spinal Deformity Correction in Adolescent Idiopathic Scoliosis

Overview

About this study

The primary purpose of this study is to evaluate the effectiveness of non-fusion surgical treatment of Spinal Deformity Correction in Adolescent Idiopathic Scoliosis.

The Post Approval Study (PAS) is gathering data on the Tether device and it's efficacy and safety.

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:  (may be modified based on the approved device HDE indications)

  • ≥ 8 years old on date of surgery.
  • Male or female.
  • Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement and a non-fusion surgery is scheduled within 4 months.
  • Thoracic or lumbar primary curves.
  • Preop Cobb Angle ≥ 30° and ≤ 65°.
  • Skeletally immature: Risser (< 5) and Sanders (< 8).
  • Spina bifida Oculta is permitted.
  • Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
  • Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
  • Failed or intolerant to bracing.
  • No prior spine surgery.

Exclusion Criteria:

  • Presence of any systemic infection, local infection, or skin compromise at the surgical site.
  • Skeletally mature: > 7 Sanders.
  • Prior spinal surgery.
  • Documented poor bone quality, defined as a T-score -1.5 or less (If DEXA collected as routine care).
  • Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient’s unwillingness or inability to cooperate with postoperative care instructions.
  • MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
  • Neuromuscular or other serious co-morbidities.
  • Thoracogenic or cardiogenic scoliosis.
  • Associated syndrome or developmental delay.
  • Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent.
  • Unwillingness to sign Informed Consent Form and participate in study procedure.
  • Subjects who are pregnant at the time of enrollment.

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