Safety and Efficacy of the CarboFix Pedicle Screw System

NCT02039232 | Completed

• 1 other identifier: CARBOFIX P CLD PPS1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Degenerative Disc Disease; Spondylolisthesis; Spinal Stenosis; Spinal Curvatures; Tumor

Outcome Measures

Primary Outcomes (1)

• Fusion success

  6 months post-operation

Study Arms (1)

CarboFix Pedicle Screw System

EXPERIMENTAL

Device: Pedicle screw system

Interventions

Pedicle screw system DEVICE

CarboFix Pedicle Screw System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CarboFix Orthopedics Ltd.: lead

Study Sites (2)

Hillel Yafe MC;

Hadera, Israel

Location

Herzliya Medical Center

Herzliya, Israel

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Spinal Stenosis; Spinal Curvatures; Neoplasms

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 17, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: February 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2018-04

Locations

IL (2)