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Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Sponsor: SpineSave AG
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2024-06-04
Completion Date
2031-08-31
Last Updated
2024-06-25
Healthy Volunteers
No
Conditions
Interventions
SpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod elastic
SpineShape System IV straight rod medium
Implantation of SpineShape System IV straight rod medium (mid-flex)
SpineShape System IV straight rod stiff
Implantation of SpineShape System IV straight rod stiff (low-flex)
Locations (2)
Spital Aarberg
Aarberg, Switzerland
Hirslanden Klinik Linde
Biel, Switzerland