An interventional study of SpineShape System IV straight rod elastic and SpineShape System IV straight rod medium in Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis and Spondylarthritis, sponsored by SpineSave AG. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by SpineSave AG · Not applicable, Interventional, and Treatment
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.
202 studies on the registry are indexed under Spondylarthritis; 51 are open to participants now.
This study's planned enrollment of 126 is above the median of 107 across 105 interventional studies indexed under Spondylarthritis.
Browse Spondylarthritis studies →This is the only study on the registry with SpineSave AG as lead sponsor.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex)
Device: SpineShape System IV straight rod elastic
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex)
Device: SpineShape System IV straight rod medium
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex)
Device: SpineShape System IV straight rod stiff
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)
Visual 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
Started Jun 2024 (actual). Primary completion is estimated for Aug 2031, 86 months after the start.
Of 46 interventional studies with no phase under Spondylarthritis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 77. This study's planned 86 months is above that.
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