Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

Myelopathy Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511445
• Other study ID #: Amedica 2010-1
• Secondary ID: NL36103.098.11
• Status: Completed
• Phase: N/A
• First received: January 13, 2012
• Last updated: July 22, 2016
• Start date: December 2011
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Amedica Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervicobrachial Syndrome
• Myelopathy
• Pain
• Radiating Pain
• Spinal Cord Diseases
• Syndrome

Intervention

Device:
• Anterior cervical discectomy and fusion (ACDF) with PEEK Cage
Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
• Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.

Locations

Country	Name	City	State
Netherlands	Medical Center Haaglanden	The Hague

Sponsors (1)

Lead Sponsor	Collaborator
Amedica Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index	The improvement in the Neck Disability Index compared to the pre-op value for each group will be compared.	12 months post-op	No
Secondary	Fusion status	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.	3 mo., 6mo., 12 mo., 24 months	No