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Completed

NCT Number: NCT01511445

Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

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.

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Key information

Conditions

Radiating Pain Central Nervous System Diseases Cervicobrachial Syndrome Myelopathy Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms Spinal Cord Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center Haaglanden

The Hague, 2501 CK, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anterior cervical discectomy and fusion (ACDF) with PEEK Cage

Device

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

Other names: Medicrea Manta or similar PEEK 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.

Other names: Valeo CSC (Cancellous Structured Ceramic), Silicon Nitride ceramic

Primary outcomes

  1. Neck Disability Index

    Time frame: 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 outcomes

  1. Fusion Status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amedica Corporation

Industry

Registry information

Official study title

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

Acronym: CASCADE

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jan 18, 2012
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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