Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

NCT ID: NCT01511445

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Anterior cervical discectomy and fusion (ACDF) with PEEK Cage

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

Anterior cervical discectomy and fusion (ACDF) with PEEK Cage

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Other Intervention Names

Medicrea Manta or similar PEEK cage; Valeo CSC (Cancellous Structured Ceramic); Silicon Nitride ceramic

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amedica Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark P Arts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Haaglanden

Locations

Medical Center Haaglanden

The Hague, , Netherlands

Countries

Netherlands

Other Identifiers

NL36103.098.11

Identifier Type: REGISTRY

Identifier Source: secondary_id

Amedica 2010-1

Identifier Type: -

Identifier Source: org_study_id