Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome (CASCADE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amedica Corporation
ClinicalTrials.gov Identifier:
NCT01511445
First received: January 13, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.


Condition Intervention
Radiating Pain
Myelopathy
Cervicobrachial Syndrome
Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage
Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.

Resource links provided by NLM:


Further study details as provided by Amedica Corporation:

Primary Outcome Measures:
  • Neck Disability Index [ Time Frame: 12 months post-op ] [ Designated as safety issue: No ]
    The improvement in the Neck Disability Index compared to the pre-op value for each group will be compared.


Secondary Outcome Measures:
  • Fusion status [ Time Frame: 3 mo., 6mo., 12 mo., 24 months ] [ Designated as safety issue: No ]
    Plane film x-rays will be used to assess fusion at all four follow-up periods. At six months a CT scan will be performed.


Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEEK interbody cage
Interbody spacer made from polyetheretherketone or PEEK plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure.
Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage
Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
Other Name: Medicrea Manta or similar PEEK cage
Experimental: Valeo CSC Ceramic Cage
The Valeo CSC cage is a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood.
Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
Other Names:
  • Valeo CSC (Cancellous Structured Ceramic)
  • Silicon Nitride ceramic

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 75 years
  • Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
  • At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)
  • Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms
  • Ability and willingness to comply with project requirements
  • Written informed consent given by the subject or the subject's legally authorised representative

Exclusion Criteria:

  • Previous cervical surgery (either anterior or posterior)
  • Increased motion on dynamic studies (> 3 mm)
  • Severe segmental kyphosis of the involved disc level (> 7 degrees)
  • Patient cannot be imaged with MRI
  • Neck pain only (without radicular or medullary symptoms)
  • Infection
  • Metabolic and bone diseases (osteoporosis, severe osteopenia)
  • Neoplasma or trauma of the cervical spine
  • Spinal anomaly (Klippel Feil, Bechterew, OPLL)
  • Severe mental or psychiatric disorder
  • Inadequate Dutch language
  • Planned (e)migration abroad in the year after inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511445

Locations
Netherlands
Medical Center Haaglanden
The Hague, Netherlands, 2501 CK
Sponsors and Collaborators
Amedica Corporation
  More Information

No publications provided

Responsible Party: Amedica Corporation
ClinicalTrials.gov Identifier: NCT01511445     History of Changes
Other Study ID Numbers: Amedica 2010-1, NL36103.098.11
Study First Received: January 13, 2012
Last Updated: March 27, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Amedica Corporation:
Cervicobrachial pain
radicular pain
arm pain
myelopathy
radiculitis
Radiating pain in one or both arms with or without signs of myelopathy.

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Pain
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014