This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
PEEK cage suitable for oblique placement in the lumbar spine
Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
Medical Center Haaglanden
The Hague, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Roland Morris Disability Questionnaire (RMDQ)
The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared
Time frame: 12 months post-op
Fusion status
Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed.
Time frame: 3 mo., 6 mo., 12 mo., 24 months
Oswestry Disability Index (ODI)
The improvement in the ODI over the pre-op ODI for each Group
Time frame: 12 months post-op
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