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
missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible
damaged structural tissue, e.g. due to a bone fracture
application to the thoracic or cervical spine
pronounced idiopathic scoliosis
SpineSave AG
Lead sponsor