NCT06320899|Recruiting
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Sponsor study identifier
Secondary identifiers
OTHER · Ethics Committee Bern
interventional
126
1 country
2
Study Start
June 4, 2024
Actual (reported)Primary Completion
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 13, 2024
Actual (reported)March 20, 2024
Actual (reported)June 4, 2024
Actual (reported)August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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"
24 months post-implantation
Visual Analogue Scale (VAS) leg pain
3, 12, 24, 60 months post-implantation
walking duration
3, 12, 24, 60 months post-implantation
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex)
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex)
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex)
Implantation of SpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod medium (mid-flex)
Spital Aarberg
Aarberg, 3270, Switzerland
Hirslanden Klinik Linde
Biel, 2501, Switzerland
Philipp Cathrein, Dr.med.
Hirslanden Klinik Linde
First Submitted
March 13, 2024
First Posted
March 20, 2024
Study Start
June 4, 2024
Actual (reported)Primary Completion
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
medication consumption
3, 12, 24, 60 months post-implantation
adverse events
after 3, 12, 24, 60 months post-implantation
segmental mobility index level
3, 12, 24, 60 months post-implantation
Implantation of SpineShape System IV straight rod stiff (low-flex)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
August 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 25, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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