Idiopathic Scoliosis
Conditions
Keywords
scoliosis
Brief summary
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.
Detailed description
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 1. The 3D correction of scoliosis: * Reduction of scoliosis in the coronal plane (Cobb angles) * Correction in the sagittal plane (kyphotic and lordotic angles) * Correction of the axial vertebral rotation in the transverse plane 2. The functional and aesthetic outcomes
Interventions
DEVICEPosterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
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.
Sponsors
Medicrea, USA Corp.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Idiopathic scoliosis requiring posterior spinal instrumentation and fusion * Male and female
Exclusion criteria
* Neuromuscular or degenerative scoliosis * Spinal cord abnormalities with any neurologic symptoms or signs * Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression * Primary muscle diseases, such as muscular dystrophy * Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, Neurofibroma) * Primary abnormalities of bones (e.g. osteogenesis imperfecta) * Congenital scoliosis * Scoliosis requiring anterior release * Previous spinal surgery * Patient who is unable to complete a self-administered patient questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes | Preoperative, 6 weeks, 6 months, 1 year and 2 Years |
Secondary
| Measure | Time frame |
|---|---|
| Functional and aesthetic outcomes | Preoperative, 6 months and 2 years |
| Perioperative and postoperative complications | Continuous during follow-up |
Countries
United States
Outcome results
None listed