CarboFix Pedicle Screw System

CarboFix Orthopedics Ltd.2 sites in 1 country46 target enrollmentJanuary 2014

Overview

The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

February 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

CarboFix Orthopedics Ltd.

Responsible Party

Sponsor

•Subject is 18 years old or older.
•Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
•Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
•Informed consent given by the subject.

•Subject is not eligible for fixation with market-available fixation means.
•Familial history NF
•Acute traumatic spinal injury with or without neurological signs.
•Metabolic bone disease.
•History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
•History of mental disorder or current psychiatric treatment.
•Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods.
•Immune deficiency disease.
•Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).
•Treatment with drugs that may interfere with bone metabolism such as: