Clinical Trial Details
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NCT02465099 : Posterior Spinal Fusion With Two Energy Dissection Techniques
PhasePhase 4
AgesMin: 10 Years Max: 21 Years
Inclusion Criteria:

1. Between 10 and 21 years of age;

2. Diagnosed with neuromuscular scoliosis associated with cerebral palsy or with
idiopathic scoliosis between the ages of 10 and 18;

3. Indicated for primary PSF surgery;

4. Anticipated >= 6 vertebrae fusions;

5. Not in need of three column osteotomy (pedicle subtraction osteotomy [PSO]);

6. Not in need of vertebral column resection (VCR);

7. Curve magnitude >45 degrees for scoliosis and for sagittal deformity; and

8. An American Society of Anesthesiologists (ASA) physical status (PS) classification of
1 to 4

Exclusion Criteria:

1. One or both parents or a guardian unable or unwilling to provide parental permission
and child assent (if capable, the child must express willingness to participate);

2. Previous failed vertebral fusion at same target levels;

3. Syndromic scoliosis;

4. Congenital scoliosis;

5. Early-onset scoliosis (onset before 10 years of age);

6. Requiring an anterior procedure;

7. Requiring PSO;

8. Requiring VCR;

9. Presence of coagulation abnormalities;

10. Planned staged procedure (exclude if second stage or beyond);

11. Requiring emergency surgery; and/or

12. Participation in any other clinical study (not to include registry or survey-only
studies) for the duration of the study.
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