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Safety and Efficacy of the CarboFix Pedicle Screw System

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ClinicalTrials.gov Identifier: NCT02039232
Recruitment Status : Active, not recruiting
First Posted : January 17, 2014
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
CarboFix Orthopedics Ltd.

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

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis Spinal Stenosis Spinal Curvatures Tumor Device: Pedicle screw system Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CarboFix Pedicle Screw System
Actual Study Start Date : January 2014
Actual Primary Completion Date : August 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CarboFix Pedicle Screw System Device: Pedicle screw system



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039232


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

Responsible Party: CarboFix Orthopedics Ltd.
ClinicalTrials.gov Identifier: NCT02039232     History of Changes
Other Study ID Numbers: CARBOFIX P CLD PPS1
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

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