Clinical trial NCT01019109: Scoliosis Surgery Using the PASS® LP System
Official title: Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Keywords: scoliosis
Lead sponsor: Medicrea, USA Corp.
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgeon's Practice/Clinic

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.

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

Eligibility 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

Primary outcomes:
measure: Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes
timeFrame: Preoperative, 6 weeks, 6 months, 1 year and 2 Years
Secondary outcomes:
measure: Functional and aesthetic outcomes
timeFrame: Preoperative, 6 months and 2 years
measure: Perioperative and postoperative complications
timeFrame: Continuous during follow-up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Healthcare of Atlanta, GA
name: Dennis Devito, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: LSU Health Sciences Center-New Orleans, LA
name: Andrew King, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital- Columbus, OH
name: Mark Willits, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chilren's Hospital of Orange County
name: Afshin Aminian, MD
role: PRINCIPAL_INVESTIGATOR
References: