Safety and Efficacy of the CarboFix Pedicle Screw System

Degenerative Disc Disease Clinical Trial

Official title:

CarboFix Pedicle Screw System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039232
• Other study ID #: CARBOFIX P CLD PPS1
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: February 2018

Study information

• Verified date: April 2018
• Source: CarboFix Orthopedics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Curvatures
• Spinal Stenosis
• Spondylolisthesis
• Tumor

Intervention

Device:
• Pedicle screw system

Locations

Country	Name	City	State
Israel	Hillel Yafe MC;	Hadera;
Israel	Herzliya Medical Center	Herzliya

Sponsors (1)

Lead Sponsor	Collaborator
CarboFix Orthopedics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion success		6 months post-operation