Safety and Efficacy of the CarboFix Pedicle Screw System

This study is currently recruiting participants.
Verified January 2014 by CarboFix Orthopedics Ltd.
Sponsor:
Information provided by (Responsible Party):
CarboFix Orthopedics Ltd.
ClinicalTrials.gov Identifier:
NCT02039232
First received: January 14, 2014
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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

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 ] [ Designated as safety issue: No ]

Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039232

Contacts
Contact: Wachsler-Avrahami +97299511511 hila@carbo-fix.com

Locations
Israel
Hillel Yafe MC; Herzeliya MC Recruiting
Hadera; Herzeliya, Israel
Sponsors and Collaborators
CarboFix Orthopedics Ltd.
  More Information

No publications provided

Responsible Party: CarboFix Orthopedics Ltd.
ClinicalTrials.gov Identifier: NCT02039232     History of Changes
Other Study ID Numbers: CARBOFIX P CLD PPS1
Study First Received: January 14, 2014
Last Updated: January 16, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Spinal Curvatures
Spinal Stenosis
Spondylolisthesis
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on April 15, 2014