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.
Dynamic stabilization systems for the lumbar spine are no novelty. The SpineShape System IV builds on the experience of previous systems and attempts to provide additional benefits primarily through three different and relatively elastic rod stiffnesses. 126 subjects with degenerative symptoms in 1 to 2 segments of the lumbar spine L1 to S1 will be recruited. The participants will be randomized in a 1:1:1 ratio to undergo implantation of either the elastic (experimental product group 1), medium (experimental product group 2) or stiff rod (comparison product group). The aim of the study is to show that the treatment of degenerative lumbar spine with elastic or medium rod variants is not inferior to treatment with hard rods in terms of clinical and safety-related results. This is checked by completing a questionnaire before the surgical procedure and 3 months, 12 months, 24 months and 60 months after the surgical procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
Implantation of SpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod medium (mid-flex)
Implantation of SpineShape System IV straight rod stiff (low-flex)
Spital Aarberg
Aarberg, Switzerland
RECRUITINGHirslanden Klinik Linde
Biel, Switzerland
RECRUITINGVisual Analogue Scale (VAS) lower back pain
self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
Time frame: 24 months post-implantation
Visual Analogue Scale (VAS) leg pain
self reported leg pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
Time frame: 3, 12, 24, 60 months post-implantation
walking duration
self reported walking duration in 5 categories (0-5 min, 6-15 min, 16-30 min, 31-60 min and \>60min)
Time frame: 3, 12, 24, 60 months post-implantation
medication consumption
use of none, mild pain medication, non-steroidal anti-inflammatory drugs, opioids, and/or antidepressiva documented in patient's health records
Time frame: 3, 12, 24, 60 months post-implantation
adverse events
adverse events related to the device (e.g. screw loosening, screw breakage, torn rod, slipped rod or too short rod)
Time frame: after 3, 12, 24, 60 months post-implantation
segmental mobility index level
measuring the segmental mobility at index level to verify the preservation of the mobility. an average mobility per segment of \>1° is considered a success
Time frame: 3, 12, 24, 60 months post-implantation
ability to work/ activity (for retirees)
self reported ability to work or activity (for retirees) in 5 categories (0%, 25%, 50%, 75%, 100%)
Time frame: 3, 12, 24, 60 months post-implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.