Scoliosis Surgery Using the PASS® LP System

• Sponsor: Medicrea, USA Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01019109
• Collaborator: (none)
• Enrollment: 79
• Locations: 3
• Duration (Months): 74
• Patients Per Site: 26.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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.

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

1. The functional and aesthetic outcomes

Study Design

• Study Type: Observational
• Actual Enrollment: 79 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

1. Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes [Preoperative, 6 weeks, 6 months, 1 year and 2 Years]

Secondary Outcome Measures

1. Functional and aesthetic outcomes [Preoperative, 6 months and 2 years]

2. Perioperative and postoperative complications [Continuous during follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30342
2	LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medicrea, USA Corp.
• ClinicalTrials.gov Identifier: NCT01019109
• Other Study ID Numbers: #0305
• First Posted: Nov 25, 2009
• Last Update Posted: Mar 21, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Medicrea, USA Corp.: scoliosis
• Additional relevant MeSH terms: Scoliosis; Cobalt

Study Results

No Results Posted as of Mar 21, 2018