Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

Not Applicable

Completed

• Conditions: Radiating Pain; Cervicobrachial Syndrome; Myelopathy
• Interventions: Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage; Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage

• Registration Number: NCT01511445
• Lead Sponsor: Amedica Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Primary Completion: 2014-10
• Study Completion: 2015-11
• Results First Submitted: 2017-01-26
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-27
• Last Update Submitted: 2017-03-27
• Results First Posted: 2017-05-08
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACDF with Valeo CSC Ceramic Cage	Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC 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.
ACDF with PEEK interbody cage	Anterior cervical discectomy and fusion (ACDF) with PEEK 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.

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	24 months post-op	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

Name	Time	Method
Fusion Status	3 mo., 6mo., 12 mo., 24 months	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.

Trial Locations

Locations (1)

Medical Center Haaglanden; 🇳🇱 The Hague, Netherlands