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

Primary Purpose

Radiating Pain, Myelopathy, Cervicobrachial Syndrome

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Anterior cervical discectomy and fusion (ACDF) with PEEK Cage
Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
Sponsored by
Amedica Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiating Pain focused on measuring Cervicobrachial pain, radicular pain, arm pain, myelopathy, radiculitis, Radiating pain with or without signs of myelopathy.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center Haaglanden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ACDF with PEEK interbody cage

ACDF with Valeo CSC Ceramic Cage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 13, 2012
Last Updated
March 27, 2017
Sponsor
Amedica Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01511445
Brief Title
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome
Acronym
CASCADE
Official Title
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amedica Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiating Pain, Myelopathy, Cervicobrachial Syndrome
Keywords
Cervicobrachial pain, radicular pain, arm pain, myelopathy, radiculitis, Radiating pain with or without signs of myelopathy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACDF with PEEK interbody cage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ACDF with Valeo CSC Ceramic Cage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anterior cervical discectomy and fusion (ACDF) with PEEK Cage
Other Intervention Name(s)
Medicrea Manta or similar PEEK cage
Intervention Description
Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
Intervention Type
Device
Intervention Name(s)
Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
Other Intervention Name(s)
Valeo CSC (Cancellous Structured Ceramic), Silicon Nitride ceramic
Intervention Description
Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
Time Frame
24 months post-op
Secondary Outcome Measure Information:
Title
Fusion Status
Description
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.
Time Frame
3 mo., 6mo., 12 mo., 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark P Arts, MD, PhD
Organizational Affiliation
Medical Center Haaglanden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Haaglanden
City
The Hague
ZIP/Postal Code
2501 CK
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

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