Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome (CASCADE)
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|ClinicalTrials.gov Identifier: NCT01511445|
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Radiating Pain Myelopathy Cervicobrachial Syndrome||Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||November 2015|
Active Comparator: 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.
Device: Anterior cervical discectomy and fusion (ACDF) with PEEK Cage
Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
Other Name: Medicrea Manta or similar PEEK cage
Experimental: 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.
Device: Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511445
|Medical Center Haaglanden|
|The Hague, Netherlands, 2501 CK|
|Principal Investigator:||Mark P Arts, MD, PhD||Medical Center Haaglanden|