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The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Scoliosis Patients | Experimental | Tether group |
|
| Pediatric Scoliosis Control Patients | Active Comparator | Fusion (control) group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVBT using Dynesys System Components | Device | Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision spine surgery within 2 years of index procedure | yes/no parameter, was revision surgery performed within 2 years of index procedure | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm) | yes/no parameter, did major Cobb angle worsen by 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film | 1 year |
| Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A. Noelle Larson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35610543 | Derived | Mathew SE, Hargiss JB, Milbrandt TA, Stans AA, Shaughnessy WJ, Larson AN. Vertebral body tethering compared to posterior spinal fusion for skeletally immature adolescent idiopathic scoliosis patients: preliminary results from a matched case-control study. Spine Deform. 2022 Sep;10(5):1123-1131. doi: 10.1007/s43390-022-00519-3. Epub 2022 May 24. |
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Tether group 40 patients and Fusion (control) group 40 patients
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| Spine fusion | Procedure | Children with scoliosis undergoing fusion surgery will form the control arm |
|
yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film |
| 1 year |
| Curve flexibility over instrumented vertebra > 5 degrees | Flexibility films will be obtained in patients postoperatively to assess flexibility | At least 1 year postoperatively |
| Spinal disc health utilizing MRI | Spinal disc health will be assessed in Tether patients post-operatively using an MRI in conjunction with the Pfirrmann classification (scored I to V, where I indicated normal and V indicated the worst degeneration). | At least 1 year postoperatively |
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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