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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01019109
Other study ID # #0305
Secondary ID
Status Completed
Phase
First received November 20, 2009
Last updated March 20, 2018
Start date May 2010
Est. completion date July 2016

Study information

Verified date March 2018
Source Medicrea, USA Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia
United States Nationwide Children's Hospital Columbus Ohio
United States LSU Health Sciences Center New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Medicrea, USA Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes Preoperative, 6 weeks, 6 months, 1 year and 2 Years
Secondary Functional and aesthetic outcomes Preoperative, 6 months and 2 years
Secondary Perioperative and postoperative complications Continuous during follow-up
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