Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative… (NCT06320899) | Clinical Trial Compass
RecruitingNot Applicable
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Switzerland126 participantsStarted 2024-06-04
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…