Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial (SNAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01557829|
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Disc Degeneration of Pfirrmann Grade III or Greater Degenerative Spondylolisthesis Isthmic Spondylolisthesis of Grade I or II||Device: Posterior lumbar interbody fusion with a PEEK cage Device: Posterior lumbar interbody fusion with a Valeo OL cage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2017|
Active Comparator: PEEK interbody cage
Posterior fusion with an interbody spacer (cage) made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is filled with local bone or bone harvested from the iliac crest.
Device: Posterior lumbar interbody fusion with a PEEK cage
PEEK cage suitable for oblique placement in the lumbar spine
Other Name: Amedica Phantom Plus or Pioneer Bullet-Tip cage
Experimental: Valeo OL ceramic cage
Posterior fusion with the Valeo OL cage, a silicon nitride ceramic interbody spacer. The center area of the cage is filled with autograft local bone or bone harvested from the iliac crest.
Device: Posterior lumbar interbody fusion with a Valeo OL cage
Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 12 months post-op ]The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared
- Fusion status [ Time Frame: 3 mo., 6 mo., 12 mo., 24 months ]Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed.
- Oswestry Disability Index (ODI) [ Time Frame: 12 months post-op ]The improvement in the ODI over the pre-op ODI for each Group
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): NCT01557829
|Medical Center Haaglanden|
|The Hague, Netherlands, 2501 CK|