Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
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
SpineSave AG
126 participants
Jun 4, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- 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 Criteria20
- 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
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Interventions
Implantation of SpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod medium (mid-flex)
Implantation of SpineShape System IV straight rod stiff (low-flex)
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06320899