Safety and Efficacy of the CarboFix Pedicle Screw System

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by CarboFix Orthopedics Ltd.
Information provided by (Responsible Party):
CarboFix Orthopedics Ltd. Identifier:
First received: January 14, 2014
Last updated: February 5, 2015
Last verified: January 2014

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

Condition Intervention
Degenerative Disc Disease
Spinal Stenosis
Spinal Curvatures
Device: Pedicle screw system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CarboFix Pedicle Screw System

Further study details as provided by CarboFix Orthopedics Ltd.:

Primary Outcome Measures:
  • Fusion success [ Time Frame: 6 months post-operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CarboFix Pedicle Screw System Device: Pedicle screw system


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02039232

Contact: Wachsler-Avrahami +97299511511

Hillel Yafe MC; Herzeliya MC Recruiting
Hadera; Herzeliya, Israel
Rizzoli Orthopaedics Institute Recruiting
Bolonga, Italy
Sponsors and Collaborators
CarboFix Orthopedics Ltd.
  More Information

No publications provided

Responsible Party: CarboFix Orthopedics Ltd. Identifier: NCT02039232     History of Changes
Other Study ID Numbers: CARBOFIX P CLD PPS1
Study First Received: January 14, 2014
Last Updated: February 5, 2015
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylosis processed this record on March 26, 2015