Safety and Efficacy of the CarboFix Pedicle Screw System

CarboFix Orthopedics

Status: Completed

Conditions: Degenerative Disc Disease; Spinal Curvatures; Spondylolisthesis; Spinal Stenosis; Tumor

Treatments: Device: Pedicle screw system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02039232

CARBOFIX P CLD PPS1

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is 18 years old or older.
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

1. Subject is not eligible for fixation with market-available fixation means.

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

CarboFix Pedicle Screw System

Experimental group

Treatment:

Device: Pedicle screw system