Safety and Efficacy of the CarboFix Pedicle Screw System

CarboFix Pedicle Screw System

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

Study Overview

• Status: Completed
• Conditions: Spinal Curvatures; Degenerative Disc Disease; Spinal Stenosis; Tumor; Spondylolisthesis
• Intervention / Treatment: Device: Pedicle screw system

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hadera;, Israel
    • Hillel Yafe MC;
  • Herzliya, Israel
    • Herzliya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CarboFix Pedicle Screw System	Device: Pedicle screw system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fusion success	6 months post-operation

Collaborators and Investigators

• Sponsor: CarboFix Orthopedics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis; Spinal Curvatures
• Other Study ID Numbers: CARBOFIX P CLD PPS1