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Safety and Efficacy of the CarboFix Pedicle Screw System

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
CarboFix Orthopedics Ltd. Identifier:
First received: January 14, 2014
Last updated: July 25, 2017
Last verified: July 2017
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 Spondylolisthesis Spinal Stenosis Spinal Curvatures Tumor Device: Pedicle screw system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CarboFix Pedicle Screw System

Resource links provided by NLM:

Further study details as provided by CarboFix Orthopedics Ltd.:

Primary Outcome Measures:
  • Fusion success [ Time Frame: 6 months post-operation ]

Estimated Enrollment: 65
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT02039232

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

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: July 25, 2017

Additional relevant MeSH terms:
Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylosis processed this record on September 21, 2017