Scoliosis Surgery Using the PASS® LP System

Medicrea

Status: Completed

Conditions: Idiopathic Scoliosis

Treatments: 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.

Study type: Observational

Funder types: Industry

Identifiers

NCT01019109

#0305

Details and patient eligibility

About

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.

Full 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

Enrollment: 79 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

79 participants in 2 patient groups

Titanium rod

Description:

Titanium rods used as a part of PSF construct

Treatment:

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.

CoCr Rod

Description:

Cobalt Chrome rods used as a part of PSF construct

Treatment:

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.