Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Key facts
- Where
- Aarberg and Biel, SwitzerlandSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06320899, who can take part
Where in Switzerland
- Spital AarbergAarberg, SwitzerlandContact: CathreinTaking people
- Hirslanden Klinik LindeBiel, SwitzerlandContact: CathreinTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- SpineSave AG
- Trial code
- NCT06320899
- Record updated
- 25 June 2024
- Original description
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.Read full original descriptionShow less
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - a Prospective, Multicenter, Randomized Controlled Non-inferiority Study
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.
Inclusion: 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: missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible; history with third party implants; immunosuppresive therapy; long-term therapy with cortisone; heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics; patients with an active local or systemic infection; known allergy to titatnium alloys; severe muscular neuronal or vascular disease; 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; skeleton in growth (epiphyseal joints not closed); chronic pain patients; incapable of judgment or emergency situation; implantation during pregnancy.