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Scoliosis Surgery Using the PASS® LP System

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ClinicalTrials.gov Identifier: NCT01019109
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Medicrea, USA Corp.

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
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
  2. The functional and aesthetic outcomes

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 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
Drug Information available for: Cobalt

Group/Cohort 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




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

Secondary Outcome Measures :
  1. Functional and aesthetic outcomes [ Time Frame: Preoperative, 6 months and 2 years ]
  2. Perioperative and postoperative complications [ Time Frame: Continuous during follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgeon's Practice/Clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medicrea, USA Corp.
ClinicalTrials.gov Identifier: NCT01019109     History of Changes
Other Study ID Numbers: #0305
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by Medicrea, USA Corp.:
scoliosis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs