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| ID | Type | Description | Link |
|---|---|---|---|
| BASEC 2023-D0092 | Other Identifier | Ethics Committee Bern |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpineShape System IV straight rod elastic | Experimental | Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex) |
|
| SpineShape System IV straight rod medium | Experimental | Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex) |
|
| SpineShape System IV straight rod stiff | Active Comparator | Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpineShape System IV straight rod elastic | Device | Implantation of SpineShape System IV straight rod elastic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) leg pain | self reported leg pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain" | 3, 12, 24, 60 months post-implantation |
| walking duration |
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Inclusion Criteria:
degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
signed informed consent of participant
confirmation of the participant that the attendance of follow-up visits are intended
Body-Mass-Index < 32
Pedicle screw axis distance < 30mm
one or more of the following indications:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Abramovic | Contact | +41448669280 | sarah.abramovic@spinesave.com |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Cathrein, Dr.med. | Hirslanden Klinik Linde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spital Aarberg | Recruiting | Aarberg | 3270 | Switzerland |
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| SpineShape System IV straight rod medium | Device | Implantation of SpineShape System IV straight rod medium (mid-flex) |
|
| SpineShape System IV straight rod stiff | Device | Implantation of SpineShape System IV straight rod stiff (low-flex) |
|
self reported walking duration in 5 categories (0-5 min, 6-15 min, 16-30 min, 31-60 min and >60min)
| 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 | 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) | 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 | 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%) | 3, 12, 24, 60 months post-implantation |
| Hirslanden Klinik Linde | Recruiting | Biel | 2501 | Switzerland |
|
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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