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The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar or thoraco-lumbar Adult Deformity | Lumbar or thoraco-lumbar Adult Deformity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyaxial posterior spinal fusion system | Device | posterior correction and fusion of the thoraco-lumbar or lumbar spine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between correction of SVA and improvement ODI | The primary objective is to evaluate the correlation between:
| preop, 3 months, 6 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correction of the sagittal parameters | Sagittal parameters are evaluated by: - Cobb angle: Thoracic kyphosis measured from T5 to T12 and between the 2 inflexion points of the curve Lumbar lordosis measured from T12 to S1 and between the 2 inflexion points of the curve
|
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Inclusion criteria
Lumbar or thoraco-lumbar Adult Deformity requiring posterior spinal instrumentation and fusion like:
Patient with a Cobb angle ≥ 30° and/or confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence
Patient ≥ 21 years old
Surgery that requires 4 or more levels to be operated
Patient with complete pre-operative radiographic data: antero-posterior and lateral standing full spine x-rays (from hips to C2) and lateral bending x-rays (standing)
Patient able to complete a self-administered questionnaire
Patient able to sign a consent form
Exclusion criteria
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Adult with a lumbar or thoraco-lumbar spine deformity
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| Name | Affiliation | Role |
|---|---|---|
| Evalina BURGER, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Denver | Denver | Colorado | 80045 | United States | ||
| Santy orthopedic center |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| preop, 24 months |
| improvement of Quality of life |
| preop, 3 months, 6 months, 12 months, 24 months |
| Complications associated with the device | Per and Post-operative device complications: Screw pull-out Loosening, breakage and pseudarthrosis based on x-rays analysis | preop, 3 months, 6 months, 12 months, 24 months |
| Complications associated with the surgery | Peri-operative data: length of operative time, length of correction time, blood loss … Surgical complications | preop, 3 months, 6 months, 12 months, 24 months |
| Coronal correction |
| preop, 3 months, 6 months, 12 months, 24 months |
| Vertebra rotation |
| preop, 24 months |
| Adjacent levels degeneration | preoperative and post-operative comparison of the disc height of the upper and lower adjacent levels | preop, 24 months |
| Fusion | standing X-Rays observations (osseous formation) | preop, 24 months |
| Lyon |
| 69008 |
| France |