Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Discopathy, Facet Joint Arthrosis, Instability Lumbar Spine, Spondylarthritis
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICESpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod elastic
DEVICESpineShape System IV straight rod medium
Implantation of SpineShape System IV straight rod medium (mid-flex)
DEVICESpineShape System IV straight rod stiff
Implantation of SpineShape System IV straight rod stiff (low-flex)
Sponsors
SpineSave AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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: * (dynamic) stenosis in the spinal canal * neuroforaminal stenosis * facet joint syndrome / spondylarthrosis * discopathy (recurrent disc hernia) * degenerative spondylolisthesis (Meyerding \<1) * instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)
Exclusion criteria
* missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible * damaged structural tissue, e.g. due to a bone fracture * application to the thoracic or cervical spine * pronounced idiopathic scoliosis * spondylolisthesis \> Meyerding grad 1 * isthmic spondolylysis * bone tumor * osteochondrosis modic type I, II or III * osteoporosis, which could impair screw anchoring * history with third party implants * patients with an active local or systemic infection * known allergy to titatnium alloys * skeleton in growth (epiphyseal joints not closed) * severe muscular neuronal or vascular disease * immunosuppresive therapy * long-term therapy with cortisone * heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics * chronic pain patients * incapable of judgment or emergency situation * implantation during pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) lower back pain | 24 months post-implantation | self reported back pain intensity using Visual Analogue Scale system. 0 no pain to 10 worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| walking duration | 3, 12, 24, 60 months post-implantation | self reported walking duration in 5 categories (0-5 min, 6-15 min, 16-30 min, 31-60 min and \>60min) |
| medication consumption | 3, 12, 24, 60 months post-implantation | use of none, mild pain medication, non-steroidal anti-inflammatory drugs, opioids, and/or antidepressiva documented in patient's health records |
| Visual Analogue Scale (VAS) leg pain | 3, 12, 24, 60 months post-implantation | self reported leg pain intensity using Visual Analogue Scale system. 0 no pain to 10 worst possible pain |
| segmental mobility index level | 3, 12, 24, 60 months post-implantation | 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 |
| ability to work/ activity (for retirees) | 3, 12, 24, 60 months post-implantation | self reported ability to work or activity (for retirees) in 5 categories (0%, 25%, 50%, 75%, 100%) |
| adverse events | after 3, 12, 24, 60 months post-implantation | adverse events related to the device (e.g. screw loosening, screw breakage, torn rod, slipped rod or too short rod) |
Countries
Switzerland
Contacts
Primary ContactSarah Abramovic
Outcome results
None listed