Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - a Prospective, Multicenter, Randomized Controlled Non-inferiority Study
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results. The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.
• degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
• signed informed consent of participant
• confirmation of the participant that the attendance of follow-up visits are intended
• Body-Mass-Index \< 32
• Pedicle screw axis distance \< 30mm
• one or more of the following indications:
‣ (dynamic) stenosis in the spinal canal
⁃ neuroforaminal stenosis
⁃ facet joint syndrome / spondylarthrosis
⁃ discopathy (recurrent disc hernia)
⁃ degenerative spondylolisthesis (Meyerding \<1)
⁃ instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)