Intervertebral Disk Degeneration Clinical Trial
Official title:
Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases: Study Protocol for a Prospective, Self-controlled, Clinical Trial
To conduct a prospective, single-center, self-controlled, clinical trial to verify the efficacy and safety of K-Rod dynamic stability system in the repair of lumbar degenerative diseases following 2 years follow-up, aiming to provide references for clinical treatment of lumbar degenerative diseases.
Posterior internal fixation and fusion systems are still one of the main methods for the
treatment of chronic back pain due to intervertebral disc degeneration, but adverse
reactions, such as accelerated regression of adjacent segments, are often inevitable during
the treatment.
At present, various pedicle screw-based posterior dynamic stability systems of the lumbar
spine have become an alternative fusion therapy for lumbar degenerative diseases. Dynamic
stability is defined to reduce the loading on the intervertebral disc/articular surfaces, to
maintain movement under mechanical load, to limit the abnormal movement of the spinal
segment, and to reduce the stress on the bone-screw interface dynamically and stably. An
ideal fixation system will be stable enough to maximize the fusion rate without the need for
excessive rigidity, as well as to maintain maximum load and physiological posture of the
vertebral segment, thereby reducing the horizontal stress of the adjacent segment.
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