Trials / Completed
CompletedNCT01019109
Scoliosis Surgery Using the PASS® LP System
Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 79 (actual)
- Sponsor
- Medicrea, USA Corp. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Posterior 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. |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2009-11-25
- Last updated
- 2018-03-21
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01019109. Inclusion in this directory is not an endorsement.