Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

NCT01511445 | Completed Results DMC

• 2 other identifiers: Amedica 2010-1NL36103.098.11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiating Pain; Myelopathy; Cervicobrachial Syndrome

Keywords

Cervicobrachial pain; radicular pain; arm pain; myelopathy; radiculitis; Radiating pain with or without signs of myelopathy.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fusion Status

  3 mo., 6mo., 12 mo., 24 months

Study Arms (2)

ACDF with PEEK interbody cage

ACTIVE COMPARATOR

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

ACDF with Valeo CSC Ceramic Cage

EXPERIMENTAL

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

Interventions

Anterior cervical discectomy and fusion (ACDF) with PEEK Cage DEVICE

Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer

Also known as: Medicrea Manta or similar PEEK cage

ACDF with PEEK interbody cage

Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage DEVICE

Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.

Also known as: Valeo CSC (Cancellous Structured Ceramic), Silicon Nitride ceramic

ACDF with Valeo CSC Ceramic Cage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amedica Corporation: lead

Study Sites (1)

Medical Center Haaglanden

The Hague, 2501 CK, Netherlands

Location

MeSH Terms

Conditions

Pain; Spinal Cord Diseases; Radiculopathy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Sonny Bal, MD
• Organization: Amedica Corporation

SBal@amedica.com

(573) 808-4512

Study Officials

• Mark P Arts, MD, PhD

  Medical Center Haaglanden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 18, 2012
• Study Start: December 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2015
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)