Comparing Mid- or High-flex Rods to Low-flex Rods in SpineShape System IV for Treating Degenerative Lumbar Spine Conditions A Randomized Clinical Study Evaluating Treatment Effectiveness and Safety

What this Trial Is About

This research aims to compare different types of rods used in the surgical treatment of degenerative lumbar spine diseases. The study focuses on patients with degenerative symptoms in one or two segments of the lumbar spine from L1 to S1. It seeks to determine whether the use of high-flex elastic or mid-flex medium rods provides clinical and safety outcomes that are not inferior to those achieved with low-flex stiff rods, with a special focus on reducing back pain and improving functionality after surgery. Participants will be randomly assigned to receive one of three types of SpineShape System IV rods elastic high-flex, medium mid-flex, or stiff low-flex. Each group will undergo dynamic stabilization surgery using the assigned rod type. The study will follow patients over five years, with evaluations occurring before surgery and at 3, 12, 24, and 60 months after implantation to assess pain levels, mobility, medication use, and other health indicators. During the study, participants will complete questionnaires and undergo clinical assessments to measure back and leg pain using the Visual Analogue Scale VAS, walking duration, medication consumption, and segmental mobility. Researchers will also monitor adverse events and participants ability to work or perform activities. The total participation spans at least five years, with regular follow-up visits to collect data on safety and treatment outcomes.

Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases