Overview

This trial is active, not recruiting.

Condition idiopathic scoliosis
Treatment 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 phase 4
Sponsor Medicrea, USA Corp.
Start date May 2010
End date March 2014
Trial size 79 participants
Trial identifier NCT01019109, #0305

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Titanium rods used as a part of PSF construct
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 Spinal System
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.
(Active Comparator)
Cobalt Chrome rods used as a part of PSF construct
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 Spinal System
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.

Primary Outcomes

Measure
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 Outcomes

Measure
Functional and aesthetic outcomes
time frame: Preoperative, 6 months and 2 years
Perioperative and postoperative complications
time frame: Continuous during follow-up

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Idiopathic Scoliosis Treated by Posterior Spinal Instrumentation. Evaluation of the 3D Correction, Aesthetic Outcomes and Quality of Life.
Principal investigator Dennis Devito, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Medicrea, USA Corp..