A Study To Create A Registry Of Non-Fusion Spinal Deformity Correction In Adolescent Idiopathic Scoliosis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Minneapolis, Minnesota: 19-010211
- Rochester, Minnesota: 19-010211
Sponsor Protocol Number: 19-010211
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