Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Recruiting · NCT06320899 · Interventional (participants receive a specific treatment) · Lead sponsor: SpineSave AG
View the official record on ClinicalTrials.gov →Interventions studied
SpineShape System IV straight rod elasticSpineShape System IV straight rod mediumSpineShape System IV straight rod stiff
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Spital Aarberg - Aarberg, Switzerland
- Hirslanden Klinik Linde - Biel, Switzerland