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.
  • Diagnosis of idiopathic scoliosis for which patient has undergone a non-fusion, anterior vertebral body tether surgical procedure for the correction of spinal deformity.
  • 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:

  • 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 post-operative 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.
  • Unable or unwilling to firmly commit to returning for required follow-up visits.
  • Unwillingness to sign Informed Consent Form and participate in study procedure.

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

Minneapolis, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Open for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Open for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions