Scoliosis Surgery Using the PASS® LP System

Idiopathic Scoliosis Clinical Trial

Official title:

Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019109
• Other study ID #: #0305
• Status: Completed
• First received: November 20, 2009
• Last updated: March 20, 2018
• Start date: May 2010
• Est. completion date: July 2016

Study information

• Verified date: March 2018
• Source: Medicrea, USA Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	LSU Health Sciences Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea, USA Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes		Preoperative, 6 weeks, 6 months, 1 year and 2 Years
Secondary	Functional and aesthetic outcomes		Preoperative, 6 months and 2 years
Secondary	Perioperative and postoperative complications		Continuous during follow-up