RecruitingNot ApplicableNCT06320899

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

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

Sponsor

SpineSave AG

Enrollment

126 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

Degenerative Spondylolisthesis Spondylarthritis Degenerative Lumbar Spinal Stenosis Facet Joint Arthrosis Discopathy Instability Lumbar Spine

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SpineShape System IV straight rod elastic, a medical device called SpineShape System IV straight rod medium, and others for people with degenerative lumbar spinal stenosis, degenerative spondylolisthesis, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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