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

Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.

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.

Study Overview

• Status: Completed
• Conditions: Myelopathy; Radiating Pain; Cervicobrachial Syndrome
• Intervention / Treatment: 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
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • The Hague, Netherlands, 2501 CK
    • Medical Center Haaglanden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index	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.	24 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Status	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.	3 mo., 6mo., 12 mo., 24 months

Collaborators and Investigators

• Sponsor: Amedica Corporation
• Investigators: Principal Investigator: Mark P Arts, MD, PhD, Medical Center Haaglanden

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (ESTIMATE): January 18, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: myelopathy; radicular pain; arm pain; Cervicobrachial pain; radiculitis; Radiating pain with or without signs of myelopathy.
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Disease; Hematologic Diseases; Syndrome; Pain; Spinal Cord Diseases; Bone Marrow Diseases; Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: Amedica 2010-1; NL36103.098.11 (REGISTRY: Netherlands Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO