Back to resultsSafety and Efficacy of the CarboFix Pedicle Screw System
Primary Purpose
Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pedicle screw system
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
- Subject is 18 years old or older.
- Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
- Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
- Informed consent given by the subject.
Exclusion Criteria:
- Subject is not eligible for fixation with market-available fixation means.
- Familial history NF2.
- Acute traumatic spinal injury with or without neurological signs.
- Metabolic bone disease.
- 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.
- History of mental disorder or current psychiatric treatment.
- 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.
- Immune deficiency disease.
- 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).
- Scoliosis.
Treatment with drugs that may interfere with bone metabolism such as:
- Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
- Calcitonin within the past 6 months.
- Bisphosphonates for 30 days or more within the last 12 months.
- Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
- Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
- Treatment by chemotherapy within the last 12 months.
- Lack of willingness to make a commitment to return for required follow up visits.
- Drug and/or alcohol abuse.
- Morbid obesity.
- Metal allergies.
- Recent use of other investigational drugs or devices (within the past 30 days).
Sites / Locations
- Hillel Yafe MC;
- Herzliya Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CarboFix Pedicle Screw System
Arm Description
Outcomes
Primary Outcome Measures
Fusion success
Secondary Outcome Measures
Full Information
NCT ID
NCT02039232
First Posted
January 14, 2014
Last Updated
April 16, 2019
Sponsor
CarboFix Orthopedics Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02039232
Brief Title
Safety and Efficacy of the CarboFix Pedicle Screw System
Official Title
CarboFix Pedicle Screw System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CarboFix Orthopedics Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Curvatures, Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CarboFix Pedicle Screw System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Pedicle screw system
Primary Outcome Measure Information:
Title
Fusion success
Time Frame
6 months post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is 18 years old or older.
Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
Informed consent given by the subject.
Exclusion Criteria:
Subject is not eligible for fixation with market-available fixation means.
Familial history NF2.
Acute traumatic spinal injury with or without neurological signs.
Metabolic bone disease.
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.
History of mental disorder or current psychiatric treatment.
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.
Immune deficiency disease.
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).
Scoliosis.
Treatment with drugs that may interfere with bone metabolism such as:
Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
Calcitonin within the past 6 months.
Bisphosphonates for 30 days or more within the last 12 months.
Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
Treatment by chemotherapy within the last 12 months.
Lack of willingness to make a commitment to return for required follow up visits.
Drug and/or alcohol abuse.
Morbid obesity.
Metal allergies.
Recent use of other investigational drugs or devices (within the past 30 days).
Facility Information:
Facility Name
Hillel Yafe MC;
City
Hadera;
Country
Israel
Facility Name
Herzliya Medical Center
City
Herzliya
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the CarboFix Pedicle Screw System
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