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The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also, this study wants to find out the effects this system has on the physical appearance and quality of life for patients with scoliosis.
The aim of this study is to evaluate the clinical, functional and radiographic outcomes following the reduction of idiopathic scoliosis.
The following will be evaluated
The 3D correction of scoliosis:
The functional and aesthetic outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titanium rod | Titanium rods used as a part of PSF construct |
| |
| CoCr Rod | Cobalt Chrome rods used as a part of PSF construct |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct. | Device | PASS LP Implant System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine only. These implants are designed to stabilize the spine during normal development of solid bony consolidation which takes about 18 months. The internal fixation devices are composed of screws, hooks,rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes | Preoperative, 6 weeks, 6 months, 1 year and 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Functional and aesthetic outcomes | Preoperative, 6 months and 2 years | |
| Perioperative and postoperative complications | Continuous during follow-up |
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Inclusion Criteria:
Exclusion criteria:
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Surgeon's Practice/Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Devito, M.D. | Children's Healthcare of Atlanta, GA | Principal Investigator |
| Andrew King, M.D. | LSU Health Sciences Center-New Orleans, LA | Principal Investigator |
| Mark Willits, M.D. | Nationwide Children's Hospital- Columbus, OH | Principal Investigator |
| Afshin Aminian, MD | Chilren's Hospital of Orange County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | United States | ||
| LSU Health Sciences Center |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
|
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |