Scoliosis Surgery Using the PASS® LP System - Full Text View

Purpose

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.

Condition	Intervention	Phase
Idiopathic Scoliosis	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.	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis

U.S. FDA Resources

Further study details as provided by Medicrea, USA Corp.:

Primary Outcome Measures:

Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes [ Time Frame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional and aesthetic outcomes [ Time Frame: Preoperative, 6 months and 2 years ] [ Designated as safety issue: No ]
Perioperative and postoperative complications [ Time Frame: Continuous during follow-up ] [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	May 2010
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Titanium rod Titanium rods used as a part of PSF construct	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. Other Names: PASS® LP Spinal System Low Profile Polyaxial Spine System Pedicular Screw System
Active Comparator: CoCr Rod Cobalt Chrome rods used as a part of PSF construct	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. Other Names: PASS® LP Spinal System Low Profile Polyaxial Spine System Pedicular Screw System

Arms

Assigned Interventions

Active Comparator: Titanium rod

Titanium rods used as a part of PSF construct

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.

Other Names:

PASS® LP Spinal System
Low Profile Polyaxial Spine System
Pedicular Screw System

Active Comparator: CoCr Rod

Cobalt Chrome rods used as a part of PSF construct

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.

Other Names:

PASS® LP Spinal System
Low Profile Polyaxial Spine System
Pedicular Screw System

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

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
The functional and aesthetic outcomes

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019109

Locations

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
United States, Louisiana
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Medicrea, USA Corp.

Investigators

Principal Investigator:	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

More Information

No publications provided

Responsible Party:	Medicrea, USA Corp.
ClinicalTrials.gov Identifier:	NCT01019109 History of Changes
Other Study ID Numbers:	#0305
Study First Received:	November 20, 2009
Last Updated:	April 22, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Medicrea, USA Corp.:

scoliosis

Additional relevant MeSH terms:

Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013