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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amedica Corporation
ClinicalTrials.gov Identifier:
NCT01511445
First received: January 13, 2012
Last updated: March 27, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, 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.

Further study details as provided by Amedica Corporation:

Primary Outcome Measures:
  • Neck Disability Index [ Time Frame: 24 months post-op ]
    The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.


Secondary Outcome Measures:
  • Fusion Status [ Time Frame: 3 mo., 6mo., 12 mo., 24 months ]
    Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.


Enrollment: 100
Study Start Date: December 2011
Study Completion Date: November 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACDF with PEEK interbody cage
Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (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: ACDF with Valeo CSC Ceramic Cage
ACDF with the Valeo CSC cage, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Mark P Arts, MD, PhD Medical Center Haaglanden
  More Information

Responsible Party: Amedica Corporation
ClinicalTrials.gov Identifier: NCT01511445     History of Changes
Other Study ID Numbers: Amedica 2010-1
NL36103.098.11 ( Registry Identifier: Netherlands Trial Registry )
Study First Received: January 13, 2012
Results First Received: January 26, 2017
Last Updated: March 27, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Syndrome
Spinal Cord Diseases
Bone Marrow Diseases
Pain
Disease
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases
Neurologic Manifestations
Signs and Symptoms
Silicon
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017