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Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

NCT01511445 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-05-08

Study results available
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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

Interventions

DEVICE

Anterior cervical discectomy and fusion (ACDF) with PEEK Cage

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

DEVICE

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

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

Sponsors & Collaborators

  • Amedica Corporation

    lead INDUSTRY

Principal Investigators

  • Mark P Arts, MD, PhD · Medical Center Haaglanden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-10-31
Completion
2015-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511445 on ClinicalTrials.gov