Safety and Efficacy of the CarboFix Pedicle Screw System
NCT ID: NCT02039232
Last Updated: 2019-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2014-01-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CarboFix Pedicle Screw System
Pedicle screw system
Interventions
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Pedicle screw system
Eligibility Criteria
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Inclusion Criteria
2. Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
3. Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
4. Informed consent given by the subject.
Exclusion Criteria
2. Familial history NF2.
3. Acute traumatic spinal injury with or without neurological signs.
4. Metabolic bone disease.
5. 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.
6. History of mental disorder or current psychiatric treatment.
7. 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.
8. Immune deficiency disease.
9. 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).
10. Scoliosis.
11. Treatment with drugs that may interfere with bone metabolism such as:
1. Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
2. Calcitonin within the past 6 months.
3. Bisphosphonates for 30 days or more within the last 12 months.
4. Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
5. Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
6. Treatment by chemotherapy within the last 12 months.
12. Lack of willingness to make a commitment to return for required follow up visits.
13. Drug and/or alcohol abuse.
14. Morbid obesity.
15. Metal allergies.
16. Recent use of other investigational drugs or devices (within the past 30 days).
18 Years
ALL
No
Sponsors
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CarboFix Orthopedics Ltd.
INDUSTRY
Responsible Party
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Locations
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Hillel Yafe MC;
Hadera, , Israel
Herzliya Medical Center
Herzliya, , Israel
Countries
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Other Identifiers
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CARBOFIX P CLD PPS1
Identifier Type: -
Identifier Source: org_study_id
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